Industry Trends

Moving Your Trials To The USA? Here’s What You Need To Know.

As the biggest market under one regulation, the US is always at the top of our clients’ lists. However, not all trials are designed for US regulations. We’re here to help you decide whether the US is the best fit for your trial, and where else you might consider running your trial for the best chance of success. 

Before diving into a US-based trial, you should know these five things about getting an IND in the USA: 

  1. Start with the end in mind. Where do you want to end? Be certain of the product labeling claims, efficacy, and safety data needed for approval. With this information, you can determine the most efficient route to plan your overall development pathway and achieve your end goal. Even if you aren’t planning to take the product across the finish line yourself, it is still worth outlining the development program as if you are to help predict challenges along the way. 
  2. Hold a pre-IND meeting. You are typically granted a finite number of Type B meetings (e.g., one pre-Investigational New Drug (IND) application meeting, one pre-New Drug Application (NDA)/Biologics License Application (BLA) meeting). Be sure to avoid open-ended questions.  You should have a fleshed-out plan to present and ask the appropriate approval agency if they agree with that plan. 
  3. Go Phase 3-2-1: Outline the ideal phase 3 study or studies in the target patient population. After designing the phase 3 study (or studies), outline the early-phase studies necessary to establish the initial safety and proof-of-concept data needed before embarking on a phase 3 program. 
  4. Be strategic—utilize plans. Use strategic development plans such as a target product profile (TPP) or an integrated product development plan (IPDP) to organize your strategy. Remember, the TPP is a roadmap of a development program and the basis for annotated product labels (for marketing applications) and intended labeling claims. The IPDP includes detailed plans for clinical, nonclinical, and Chemistry, Manufacturing, and Controls (CMC) programs. 
  5. Be brave. Don’t follow the usual path. It’s easy to fall into the same strategy and game every other trial runs through. Be sure to step outside the box. Are you working with a site because it’s the best site to work with, or is it because the site is well known? Are you working with vendors that can deliver effectively and on time, or are you sticking with the same vendors that everyone else is using? Seek advice, research, and don’t be afraid to try something new. 

Looking for help planning your trial in the US? I’m here to help. Please visit my page to schedule a meeting.  

About the Author: With more than 12 years of industry experience, Gavin Li is Director, Business Development, Asia-Pac, at PSI CRO.  

Moving Your Trials To The USA? Here’s What You Need To Know. Read More »

globe view of asia

From Asia to the World: 5 Tips From The CRO That Delivers Studies on Time

At PSI, we see an exciting future for pharma and biotech developments in Asia. Smart people are creating smart ideas and innovations to change the world.  

PSI has a reputation for delivering. How do we run trials on time? 

  1. Focusing on a select few indications. This specialized focus allows us to build and maintain reliable site networks, detailed experience portfolios, and optimized process improvement strategies. 
  2. Treating our sites as clients. We believe that patient recruitment is foremost influenced by investigators, study nurses, and local site teams. PSI encourages teams by providing individualized, tailored support to local sites to increase site engagement and patient enrollment. 
  3. Creating stability and consistency. We are privately owned by the same group of people who founded the company more than 25 years ago, and we’re dedicated to delivering unmatched reliability and unparalleled support. Our teams understand that our clients come first and foster a company culture where our employees enjoy their careers and want to stay long-term. That means that the project team you start with will be the team that sticks with you throughout the entirety of your trial.  
  4. Building client loyalty. Our repeat and referral business rate is 95%. PSI focuses on working with biotech and small-to-midsized pharma companies because we understand these clients’ specific needs.  
  5. Staying accountable. 93% of all our trials ended on time or ahead of schedule in 2023. This impressive delivery rate is our claim to fame. Too many CROs fall short of expectations, and we’re working to change that trend.  

Ready to learn more about running clinical trials with PSI? I’m here to help. Please visit my page to schedule a meeting. 

About the Author: With more than 12 years of industry experience, Gavin Li is Director, Business Development, Asia-Pac, at PSI CRO.  

From Asia to the World: 5 Tips From The CRO That Delivers Studies on Time Read More »

Case Study: Delivering a Global Pivotal, Phase 3 Trial in 2020

Design: Adaptive, Randomized, Double-blind, Double-dummy, Prospective Trial 

Phase: III 

Drug Class: Antibiotic 

Indication: Complicated urinary tract infection (cUTI)

Geography: 15 countries across three continents: USA, Bulgaria, Czech Republic, Estonia, Georgia, Hungary, Latvia, Moldova, Poland, Romania, Russia, Serbia, Slovakia, Ukraine, South Africa 

Sites: 101 sites, more than 95% enrolled patients 

Simply put, delivering trials is what we do. It’s our expertise – it’s what we’re dedicated to, and it’s what our teams are built for. But, not so simple, is the trial itself. In fact, when has an Adaptive, Randomized, Double-blind, Double-dummy, Prospective Trial been easy? When has a pivotal, phase 3 program been defined as “simple” by any means?

At PSI, we can do hard things. And that’s how we ran this study in 15 countries, across 3 continents, at more than 100+ sites. Take a look at the video below to learn more about the study, and see the hidden dimensions behind what it takes to enroll.

We completed enrollment on time, with Last Patient In (LPI) occurring during the peak of the first COVID-19 wave. Because PSI invests significant time and resources to build close site relationships, our CRAs are considered as ambassadors of the sites – they go further than what is typical across the industry. This means that sites want to work with PSI, they prioritize our studies, and we understand their preferred methods of working. In turn, we’re able to complete enrollment on-time, even in the midst of a global pandemic.

We Can Do Hard Things

PSI enrolled the described trial at a rate 23% higher than industry metrics in the same indication, while achieving all key milestones on schedule.

To say that this wasn’t easy would be an understatement.  Where did anyone see an easy phase III trial lately:  timelines slip, vendors get acquired, standards of care change, interest dwindles, competition doesn’t stand still…the list goes on and on.  These studies are meticulous, and require a great amount of time and attention. 

Making the Difference: The Right Team

It takes an inordinate amount of dedication, uncommon commitment to owning contractual promises and a team that’s stable, dependable and focused on the right things at the right time.  Do you want to work with a team like that?

Contact us today to discuss your pivotal trial needs!

Case Study: Delivering a Global Pivotal, Phase 3 Trial in 2020 Read More »

Of Course Your Clinical Trial is Delayed: Ready for a Divorce?

Even if your trial wasn’t already delayed before COVID-19, it probably is now. And although the world is slowly going back to “normal”, it’s going to take a new kind of resilience to catch up and get back on an acceptable track.

In light of the pandemic and looming revenue plunges, many CROs started reduced their workforces early on, making steep cutbacks, and introducing hiring freezes.  With so many CRO folks laid off or fearing for their jobs, who and how is going to step up and to take care of the enormous backlog?

The authorities did their best to jump in and ease up the stringency on protocol deviations during the pandemic. Tech providers came up with a few on-line solutions to substitute physical presence. And yet the bulk of the make-or-break work to spike up that patient enrollment graph is in the hands of CRO clinical teams and their tenacity and result-oriented style of working with the sites.

All this is to say, it’s the perfect time to question whether your CRO has the grit, the stable study team, and a trust-worthy plan to transition from a delay to a more-or-less timely LPI without sending the cost of your trial through the roof.

No surprise that these days we are seeing a considerable uptick in requests to transition or rescue entire pivotal studies and phase III programs away from former CROs. And there is a lot more observable agility about making CRO transition decisions.  Just like divorce rates spiked after the weeks of lock-down, sponsors have become much more resolute about making CRO changes here and now.

It’s hard, but not as hard as you might think

Just like a divorce, it can be an emotionally draining experience, though it doesn’t have to be. If your new CRO has well-established transition processes, checklists, per-country requirements, ample support from in-house regulatory and legal staff savvy in CRO transition particularities in each of the involved countries, and a good plan for how to communicate with the sponsor and former CRO for the next few months, you’ll be fine.

Having taken part in hundreds of rescues and dozens of major full-service take-overs we have established SOPs, detailed processes and smooth communication techniques to facilitate the transition. Our 7-Step CRO Transition Program has been run and tested on several pivotal transitions just in the last few years, resulting in increased enrollment rates and reduction of the overall study timeline every single time.

Your CRO keeps changing people?

Great enrollment should be largely attributed to great site relationships – specific people at the CRO having built trust and rapport with specific people at the trial site, and these specific CRO people being available to work on your study.

No amount of expensive technology or promised access to patient banks can replace the good old power of a strong human connection. If the investigators are not excited about working with your CRO (meaning CRO’s specific people visiting, calling on, talking to their site staff), chances are they may not be that excited about enrolling patients in your study.

When we are asked to assess the enrollment potential of a lagging study, we would always take into account whether the right sites had been chosen to begin with and, if so, have they been nurtured enough to produce results.

You’ll be surprised how easy it is to tell after a careful glance at the site list and a few conversations with the site staff why enrollment hasn’t been quite happening. Often, just like Sponsors, the sites point at the unfortunately high turnover of people they are dealing with on the CRO side.

It doesn’t have to be the lasting fate of your study. And if it is, come talk to CROs who are known for exactly the opposite: very low staff turnover rates and top investigator ratings. I bet these two are somehow connected.

Where does one find a stable CRO these days?

In Switzerland… Just kidding. Well, maybe not. Everything is stable in Switzerland, they might as well have stable CROs!

Look for someone who’s privately owned by management and doesn’t have to report to anyone but themselves, never borrowed a dollar, has always been fully self-financed through clinical project work, has grown into a global organization by meticulous hiring, training, and cultivation of company culture, has a great reputation (you find that out by talking to their clients) and are known for uncompromised focused on delivery and service.

If you find them, chances are you are finding a partner for life.

About the author: Olga Alfonsova has been with PSI from day one and has overseen launches of dozens of CRO transitions. If you’re a sponsoring company considering a CRO change, you can reach out to her for a free consultation by leaving a comment here or through her LinkedIn page.


Of Course Your Clinical Trial is Delayed: Ready for a Divorce? Read More »

Clinical Trials Are Only Getting More Complex, and Wishful Thinking Has to Go

It’s getting harder for sites. It’s getting harder for patients. And that’s not the only problem.

If you look at the data trends over the last decade, there’s no avoiding the truth: clinical trials are getting more complex, and every year. According to Tufts’s Ken Getz, “protocol design elements associated with protocol execution have grown rapidly” as demonstrated in a comprehensive study comparing 2010-2005 and 2011-2015. Getz and his team’s research indicated that even with the decline of some routine procedures – like blood tests – overall the cost per volunteer has grown due to a hefty increase in the total number of procedures: a 69% growth in Phase II and a 49% growth in Phase III.

Outside of Tufts, there is little discussion as to what this means for sponsors and, most importantly, for patients. It’s an ugly truth buried in proposals and budgets that many CROs are just willing to gloss over and avoid. We are asking more of patients, more of sites, and as medicine becomes more personalized and integrates more technology, the budgetary bloat easily gets out of hand.

But what does that mean for patient enrollment? Are more complex trials positively impacting patient recruitment? With no end in sight to the constant technological and data-centric “solutions” in the industry, the outcomes should be the best indication.

Getz says that’s not the case at all: “These study findings are striking given research linking protocol complexity to longer cycle times, higher numbers of protocol amendments and lower patient recruitment and retention rates. The collection of excessive and unnecessary clinical data may also compromise data integrity and analysis, lead to higher error rates, drive longer study durations, and delay submissions to regulatory agencies.”

So this steep increase in complexities isn’t actually moving the dial.

The Cost of Big Promises in the Face of Over-Complicated Clinical Trials

From the start, CROs need to be candid with sponsors about trial complexities and their ramifications in the process. It’s easy to fall into a mode of wanting to please everyone. A trial in a promising therapeutic area or with an exciting new molecule might get teams ready to bend over backward to make an appealing proposal and win business. But half-empty promises don’t lead to good relationships, repeat business, or trust. The biggest issue with over-promising and under-delivering is the impact on budgets and, ultimately, lackluster patient enrollment.

Sponsors end up burned when CROs are falling short of tackling challenging protocols, but they’re not the only ones. Patients suffer, too. Due to the collaborative nature of protocol development, it’s easy for each “piece” to fall into place but not work harmoniously as a whole. CROs should be part of the conversation, helping to advocate for protocol clarity aimed at making the enrollment process easier on the patient. Often, overlooked components of a protocol – like considering the burden on the patients from multiple angles – fall by the wayside.

Rhonda Critchlow, PSI’s Senior Director, Operations Oncology at PSI, explains: “We really should be tapping into patient advocacy groups, listening to the key opinion leaders at sites and asking: is this protocol going to be burdensome on the patient? Do we really need to do an 8 hour PK and a 12 hour PK, for example.” This means considering operational, real-world applications. Additional PK infusions mean more staff needed, more attention given to patients who will need more accommodations and a likelihood that many patients will simply feel that the ask is too high. These kinds of ramifications must be addressed early on in protocol discussions, and the right CRO will spot possible pain points.

Too many interventions may make the clinical trial unappealing to the patient who is often already under a lot of medical treatment. Unless the science is truly groundbreaking, it’s a difficult sell to patients and their families who may be on limited time as it is. And although patients receive informed consent documents, they’re often not provided enough information written in lay person’s perspective, presented in a way that clearly outlines the risks and the benefits of the trial. It puts a bit too much of the responsibility to put that information solely in the hands of investigators and site coordinators when CROs can partner with sponsors to provide that level of detail earlier on in the process.

When Technology Becomes Just Another Complication

New technologies crop up in clinical trials every few seconds, it seems, and while innovation is tantalizing – and can help smooth over difficult aspects of running clinical trials – they can also add undue complications. The trouble is that technologies aren’t one size fits all: not for every sponsor, not for every indication, not for every site, and especially not for every patient.

Working in an elderly population, for example, may end up benefiting a vendor but not actually impacting enrollment at all. eDiaries, for example, may be a roadblock for elderly patients with visual or hearing impairment or without access to the internet. Software designed to monitor taking medicine might glitch out and give false positives or negatives, putting the study at risk, when an office visit would have sufficed. The focus should never be on the technology: it should start with the patient.

The same can be said for a wide array of technological add-ons. If they’re not benefitting the patient, if they’re not going to help move the dial toward faster, more efficient enrollment, it’s important to take a very good look at the whys and hows. It’s easy to be distracted by the new and now, but just because the technology is state-of-the-art, it doesn’t mean the impact is measurable or beneficial to the study on the whole.

But Sponsors Need to be Willing to Listen, Too

Spilling hard truths that sponsors don’t want to hear can be a precarious situation. But with the right relationships, sponsors will collaborate with the CRO, especially when it comes to patient enrollment issues. “PSI never shows them the problem without giving them an alternative solution,” says Critchlow. “Sometimes the enrollment rate might be lower than what the sponsor is seeing, and not every client will not want to hear the reality. Ultimately it comes down to patient lives and costs along the journey, and that’s always our focus.”

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Latest eBook: PSI CRO with InformaConnect

Radiopharmaceuticals, Partnerships, and More with InformaConnect

What does it mean to build partnerships between CROs and small biotechs and pharmaceutical companies? In their latest Clinical Trials eBook Series, InformaConnect dives in to hear from both biotechs and CROs to learn about their approaches to partnership. 

Learn from Michael Zörer of AOP Orphan Pharmaceuticals, read about the key components of global coordination and cooperation for successful radiopharmaceutical trials from PSI CRO, and continue on to gain additional insights into the world of CRO and biotech partnership. 

Click here to access the eBook! 

This content is brought to you by InformaConnect



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For Radiopharmaceutical Clinical Trials, Cooperation & Coordination on a Global Scale is a Must

Radiopharmaceutical therapy isn’t exactly new using radionuclides to target cancer cells via an antibody or other conjugate has been in clinical trials for well over twenty years — but it continues to challenge how clinical trials are run across borders.

Due to the complexity of regulatory requirements within each country, clinical trials in radiopharmaceuticals run the risk of becoming delayed due to a myriad of possible complications. Because progress isn’t just about advancing new therapeutic agents but also navigating through the new regulations needed for these radioactive isotopes to travel about the world.

“Using radiopharmaceuticals as treatments is the biggest change over the last few decades,” says Rhonda Critchlow, Director of Operations, Oncology at PSI CRO. “Originally the only treatment was for thyroid conditions. Now we’re seeing it for prostate cancer, treating bone metastases, some neuroendocrine tumors, with more indications to come. We’re seeing a lot more of those products that are in clinical trials or moving out to approval.”

Nuclear medicine therapy uses radiopharmaceuticals to target specific tumors by delivering radiation to cure or control the disease. It can also be used either on selective targets or throughout the entire body or even combined with immunotherapy which uses the body’s own immune system to target the disease. When monoclonal antibodies are paired with a radioactive substance they can target cancer cells and deliver high levels of radiation directly to the tumor. Zevalin® (Ibritumomab tiuxetan) was the first pharmaceutical for radio-immunotherapy commercially available worldwide. In February 2002, the U.S. Food and Drug Administration (FDA) approved it for the therapy of recurrent and resistant forms of low-grade follicular B-cell non-Hodgkin’s lymphoma.

But we’re not talking traditional drugs: we’re talking about administering a product that has a very short half-life quickly starts to decay and become inert, hampering its usefulness to the patient. Cooperation and coordination is imperative every step along the way: from the facilities and procedures where the nuclear material is produced, to their handling and storage, all the way to the transportation of the drug and dispensation. In extreme cases, sites need to be chosen due to their proximity to the manufacturing site, with transport plans & timelines showing the maximum distance between the two locations. At every stage of its life, from its creation in the cylinder (called a cyclotron), or a reactor,  to when it is given to a patient, and even beyond that, stringent regulations abound, especially on a global scale.

Many radiopharmaceuticals are now in clinical trials or moving out to approval. But timeliness defines each and every turn. Rhonda Critchlow points out, “In the US, the regulatory issues are as big as those outside of the US. But it’s true for just about any country that when it comes to these drugs; it’s all around the timing. There are always things that come up that you have to be ready for.” Anticipation is key.

Crossing Borders

When it comes to radiopharmaceuticals, regulatory is the name of the game. Stringent regulatory guidelines above and beyond the normal process have the possibility of hampering the process every step of the way. Having a CRO that understands these new regulations, not just in one country but many is imperative. Delays can occur, for example, in obtaining core submission documents. When there are queries from competent authorities those queries can take time to answer and resolve.

Having only limited experience with the regulatory process in multiple regions for clinical trials can lead to long delays. “In Europe, every country and almost every site has a different set of rules,” says John Round, Director of Business Development at PSI CRO. “That’s the added value we provide our clients simply because we’ve been involved in this area long enough, so we know what the rules are for 17 countries in Europe. There are a lot, and they’re all different.”

This is especially the case outside of the US. According to the National Center for Biotechnology Information, “in every single EU member state there is national legislation on medicinal products referring to EU directives, and in some instances, to regulations issued by the national competent authorities. Despite their shared references to the relevant EU directives, national regulations are not exactly equivalent to each other.”

Alan Morton, a Supply Chain Manager for PSI, explains that “transportation across borders needs to happen in accordance with the International Air Transport Regulations (IATA) Dangerous Goods Regulations (assuming it is being transported by air – other regulations cover surface transport).  These govern how the supplies should be packaged and labeled for transport depending on the type and activity of the material being transported.  US 49CFR Part 173 provides this direction for moving the material within the US.”

These directives are often based on jurisdictional politics and not usually on scientific evidence. This can hinder country cooperation which can lead to untimely delays and higher costs.

A good example is Germany. The Federal Office for Radiation Protection (BfS) must grant additional approval. This review can take time, almost seven months. Additionally, selected sites require specific training certificates. Plus, the manufacturing process is very different between a clinical trial vs routine practice, which means that a special manufacturing license is required for anything involving nuclear pharmacies.

The US requires approval from the Radioisotope Review committee, and that is needed before IRB submission for most sites. The sites that use Central IRBs are usually approved within 3-4 months. However, there are some that have to go through local radiation committee approval and local IRB waivers that will take 4-6 months to approve.

In Finland, an ethics committee and Regulatory Agency (Fimea) conducts reviews of studies with radiolabeled diagnostic ligands. Fimea recommends that a trial-specific calculation on radiation burden is included into submissions packages and that the radiation burden calculations are outlined in order to reduce delays.

Additional Considerations

Regulatory challenges just scratch the surface. There are even more obstacles standing in the way of running successful radiopharmaceutical clinical trials. Additional time, resources, and budget are required for applications for radiolabeling. CROs with little or no experience in radiopharmaceutical clinical trials often struggle to coordinate all these shifts in their typical mode of operation.

Only a few nuclear pharmacies can provide the needed expertise and support for such trials, including staff and facility adjustments. There are also restrictions to site locations. This is because of the instability of the radiolabeled product, if it is to be transported to a single-photon emission computerized tomography (SPECT) facility for example.

This also extends to the imaging devices used to track the isotype inside the patient. All cameras used in the radiopharmaceutical clinical trial have to be validated. There’s a whole process required to validate cameras across sites. And that needs to be done before you even start the study. Knowing that validation has to occur and making sure it occurs in a timely manner, gets documented and submitted and proofed is all part of running that trial.

Even the manufacturing of these supplies becomes a concern. “Normally supplies are packaged, released for a study, then have some time prior to being dispensed to a patient – in some cases, this can be months or years,” Alan Morton points out.  “Due to the sometimes very short half-life when shipping ‘hot’ products, it is not uncommon for radiopharmaceuticals to have the manufacturing process to be turned backward and be scheduled to meet with a specific patient visit. This means that the production, release (QP Release, if within the EU) and transport to the site need to be coordinated with absolute precision in order to meet with the date & time of the patient visit.”

Currently, each country has their own set of rules and regulations for radiopharmaceuticals. There is no uniformity at present, so understanding the granularity and variety at the country level is imperative.

An article by the Journal of Nuclear Medicine states that “extensive documentation is required for investigational submissions. Although use of the common-technical-document format has been undertaken, a harmonized format between regulatory authorities and radiopharmaceutical-specific documentation has not yet been realized. This realization is vital, because reform and standardization will streamline submission preparation and review time and potentially decrease costs. An effort as simple as harmonizing submission document names between countries would be a significant step in more effective communication between jurisdictions.”

The Next Phase

Harmonization may take time to implement — if it can even be achieved. Granted, this is nothing new in terms of regulatory requirements; however, keeping abreast of new laws and requirements that crop up daily for radiopharmaceutical therapy is the key to successful clinical trials.

The ability to safely bring this new treatment from the clinical trial side to the bedside of the patient is paramount. Creating uniformity across global borders is still a long way off. Until then, clinical research organizations must be diligent and informed about the complexities of the regulatory process for radiopharmaceuticals. Only through knowledge and cooperation will clinical trials in this therapeutic area continue to move toward timely success.

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The quest for patient centricity: The travel conundrum

Patient enrollment represents a central part of a clinical trial. Simply put, if patients aren’t enrolling, the study isn’t happening. 

The success of enrollment, especially in an on-budget and on-time manner, is dependent on how willing the patients are to enroll and how well the sites are motivated to involve the patients in one trial versus another. With much focus put on patient-centricity these days, it stands to reason that sponsors and CROs alike would invest a lot of time into thinking like a patient when designing and planning clinical trials.

One challenge that faces patient enrollment, often seen in difficult to recruit indications or indications among sick populations, is transportation and travel. In some countries, a train ride is all that’s needed to get from points A to B. In others, it’s nowhere near as easy. This is particularly true for patients that are chronically or terminally ill, or those with significant financial challenges. It’s reported that transportation concerns are a significant barrier to entry for patients enrolling in clinical trials.

But what does the current travel landscape look like? And what advances, in this time of incredible technological growth, look like? Recent statistics show that only about half of clinical trial sites offer transportation reimbursement in one form or another, but taxi services are still overwhelmingly the most common form of transport. 

Thinking Like a Patient Should be Uncomfortable

Committing to be patient-centric means more than examining a demographic readout or inviting a patient advocacy organization to contribute to protocols. It requires us to consider the true ramifications of disease on a patient’s life. It means looking them in the eye and imagining the cataclysmic shift of a cancer or an autoimmune disease diagnosis and understanding all the intersections of their lives that change. The harsh reality is that many studies require taking time out of sick patient’s lives, patients who may know their prognosis is bleak. Late stage cancer patients consenting to clinical trials are giving something irreplaceable to the study: their limited time. And successfully enrolling patients hinges on a deep understanding of that limited resource.

And for travel, the focus should be on making the process as comfortable as possible. That doesn’t mean just enlisting any travel vendor. It means stopping to think about what travel would be like for a patient with a terminal diagnosis. Or, it means considering what a lengthy trip might mean to a patient with Crohn’s disease; or the comfort of a seat for a patient with severe rheumatoid arthritis. Patient centricity means stopping and truly considering the ramifications of a patient’s disease, and how that impacts their participation in clinical trials even before they’ve ever set foot in a clinic or hospital.

Most frequently, sponsors or CROs contract with travel vendors to help arrange patient transportation. This is, of course, essential from a privacy perspective. However, just because the vendor is the one working directly with the patients doesn’t mean CROs are off the hook for quality. There’s been a lot of discussion regarding ride-sharing or Uber-like options, one of the only signs that clinical trials transportation is changing at all. Although it’s a promising idea on the whole, this approach works best with patients who are relatively healthy. Because it’s not just about physical comfort, but about the psychological comfort of patients as well. It’s likely that sponsors and CROs are attracted to ride-sharing concepts because it promises cost-savings. Sure, saving money is a good idea, but whether or not the model will work on a large scale is up for debate. And considering Uber’s reputation for spotty and inconsistent service quality, it would beg the question if such an approach even makes sense for patient populations at all. 

We need to be vigilant with transportation vendors and wary of quick fixes. This should include a robust vendor management audit, on-site visits, review of referrals, and discussions about the variety of services offered. Ultimately, the sponsor or CRO should be the entity making the call about the level of service delivered during transportation, not waiting for vendors to rise to the occasion. 

If possible, CROs could even work directly with transportation vendors to design new, innovative approaches to travel: consider the comfort of the car seat, the availability of toilets, the temperature and amenities included. What worked for one clinical trial in a certain indication may not be as effective in another.

Digging Deeper in the Commitment to Patient Centricity

The heart of patient centricity isn’t a blanket statement promising to focus on patients as a whole. It’s action. It’s a radical shift from thinking of patients as data points – part of a product – to understanding them individually. It’s about learning to see each patient—their disease, their age, their lives, their time. 

Mitigating the burden of clinical trial participation is absolutely essential to enroll studies on time and to provide patients with a positive experience. Making that first impression, going the little extra mile by offering better transportation options, will go a long way in ensuring that everything possible has been done to get life-saving drugs to market in a timely, cost-effective way.

The quest for patient centricity: The travel conundrum Read More »

Patient Centricity: Buzzword or Rebirth of the CRO Industry?

Browse through any clinical trial-focused conference agenda around the world, and you’ll see a new, hot, must-attend topic: patient centricity. At first glance, it seems relatively straightforward, right? After all, patients are literally where clinical trials happen. We ought to consider them in the work we do. That should go without saying.

Yet, and as with so many trends turned buzzwords, in spite of the popularity of patient centricity, there’s a distinct lack of clarity as to what it even means. There are dozens of articles, panels, and papers about the importance of patient centricity; new technologies spring up every day, and patient advocacy is suddenly on everyone’s minds. We’re willing to invest to look good, it seems. But try and find an in-depth critique, or deep data, on the results of patient centricity, and you’ll come up relatively empty-handed. New technology, digital enrollment, VR, or any other new trend, does not equal patient centricity. It may be part of it, but it is not the whole sum.

The truth is, our industry has avoided the voice of the patient for years. And now that it’s all the rage, we’re scrambling to look good for sponsors, investors, and ultimately, patients. You could go as far as to say that the concept of patient centricity has been obscured significantly in the last few years, diminished to little more than another sales ploy, that all-important punctuation for sponsors to help in their decision-making processes.

But it doesn’t have to be that way. The truth is that patient centricity, real patient centricity, is difficult but essential. And companies hoping to get by on the least effort are going to be in for a big surprise in the next few years if they don’t learn to adapt.


Marketing and Patient Centricity

Patient centricity, as a concept, isn’t new. In fact, it owes a certain debt to consumer marketing. In brand lingo, it’s called the customer journey, and it’s a new way of thinking of the end user first, rather than the brand’s messages or aims.

Forrester defines the customer journey as “…the series of interactions between a customer and a company that occur as the customer pursues a specific goal. (The journey may not conform to the company’s intentions.)”

In the clinical trial space, by extension, that means that the planning, protocol, goals, and means, should all consider the patient first. And though it looks very good on paper, many “patient centricity” attempts still define the trend by their own goals. Here is an example:

Patient centricity in clinical trials means designing clinical trials so their endpoints and objectives are in the interest of the patient community.  

Unfortunately, the patient is significantly divorced from the actual aim in this definition: we’re talking clinical trial endpoints and objectives. It looks right on a first glance, but what does “interest in the patient community” mean, anyway? How is it measured? How does it change the goals of the trial?

Like the customer journey, patient centricity seems a natural fit in the information age. Everyone has a voice, and the digital landscape is a breeding ground for data. Simple social media searches can help predict outbreaks. Complex algorithms can break down the prevalence of certain diseases in patient populations.

But it’s not so easy to be patient-centric. It requires doing a whole lot more. According to Hensley Evans of Zs, getting pharmaceutical companies on board isn’t easy. “Pharmaceutical companies are anxious about having direct conversations with patients. There’s been so much concern about adverse event reporting, and compliance and regulatory issues,” Hensley says. It’s not just about listening to patients, it’s about being willing to make changes and adapt on their behalf. And clinical trials are notoriously bad at adapting.


The Cost of Failure Isn’t Just Measured in Dollars

That’s because the problem, of course, isn’t simply humanitarian, nor is it something that patient centricity can solve. It’s about money, time, and effort. As costs have grown exponentially, the industry has had to examine their approach to clinical trials as a whole. The interest in patient centricity arose when it became a cost issue: the demand for new drugs has surged, and along with that, general distrust from consumers regarding pharmaceutical companies (recent surveys have the distrust percentage dropping from 51% to 38% in 2018). Turning patients into products didn’t work, so now companies are scrambling to involve patients in the trial at every step, even if it isn’t working it appears to be a good selling point.

Yes, cost is one of the problems, but claiming that patient centricity is going to be a panacea is far from realistic. With only 3-5% of the population participating in clinical trials to begin with, a new picture emerges. How do we truly commit to patient centricity when we have such a low permeation among patients themselves? Patient centricity has to start before the trial, in many ways, to truly make an impact. And that means some seriously hard work on the side of CROs and sponsors in terms of their site relationships.

Throwing new technologies, new buzzwords, and new price tags on patient centricity isn’t going to solve the problem: not enough patients are involved in clinical trials, and that’s mainly due to the fact that CROs struggle to start with the patient as a person and not a point of data. When we consider the sobering facts that contribute to the larger problem, we see an even bleaker picture: about 80% of clinical trials fail to finish on time, the dropout rate is about 30%, 50% of sites fail to enroll a single patient, and a staggering 85% of trials fail to retain enough patients. As an industry, those numbers are sobering, to say the least. Not only do these factors drive up the cost of running trials globally, but when you consider that roughly 14% of drugs in clinical trials go on to FDA approval, it’s clear that life-saving medicines aren’t making it to patients in time.

Does Patient Centricity Always Mean the Patient is Involved?

Sitting down across the table from a patient might not always be the best idea, though it certainly looks good on paper (and, let’s face it, on a shiny brochure). But we’re forgetting the most important piece of the puzzle: being patient-centric means thinking about the patient, and their suffering, first and foremost. That means eliminating hurdles in the clinical trial process. Those costly delays? It’s not just sponsor’s dollars that are at stake here: it’s patient’s lives. Patients need new drugs sooner, and we’re failing them in almost every possible way, all while saying we’re trying to focus more on patients and their needs. Most CROs just aren’t willing to change and to improve their efficiencies to meet those needs.

Take site agreements. While the tedious process goes on and on, patients are literally dying before they can even participate in a trial – at that point, does it matter if they had a look at the protocol? Not for the individual who’s battling a terminal illness. Contract negotiations, according to CenterWatch, makes up $350M annually in spending. Forget dollars: that’s a ton of time.

And here’s an interesting tidbit. From the CenterWatch article, quoting Susan Caruso, WSG’s vice president for clinical solutions: “… if it takes 130 days on average to open a site in Poland and 75 in Spain… why wouldn’t you choose to go to Spain?”  Does this make Spain generally more patient-centric than Poland?

The interesting question that we may want to ask ourselves is how can we as an industry become truly patient-centric by cutting out the unnecessary red tape and minimizing all the known hurdles on the way to on-time study start-up and patient enrollment. That would be really patient-centric, wouldn’t it?

What do you think about patient centricity? What does, and doesn’t, really qualify? How can we improve efficiencies in the industry?

In the coming weeks, we’re diving deeper into what patient-centricity really means. If you’re ready to hear more, sign up here and we’ll let you know as soon as the next article in the series is available.

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PSI Earns Five CRO Leadership Awards

PSI CRO, ZUG, SWITZERLAND, 15 March 2019 – PSI CRO has received CRO Leadership Awards in five categories, including Compatibility, Expertise, Quality, Reliability, and Capabilities across two respondent groups (Overall and Small Pharma). The CRO Leadership Awards are presented by Life Sciences Leader based on research conducted by ISR reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.  

PSI’s President Nick Sinackevich said, “Receiving the CRO Leadership Award for the second year in a row is immensely gratifying. Collecting top rankings in as many as five categories — compatibility, expertise, quality, reliability, and capabilities – makes it sweeter still.  A heartfelt thank-you goes to those loyal customers who have cast their vote in our favor and, even more so, to the PSI employees who wowed the customers with their superb effort and commitment in the first place.” 

The CRO Leadership Awards utilize the ISR’s Contract Research Organization Quality Benchmarking annual online survey as the basis for recognition. For this round, 60 CROs were evaluated on more than 20 performance metrics. “We believe the CROs receiving an award this year are truly at the top of their class and are deserving of this recognition. Being a top performer in any of these categories shows a level of expertise and commitment to clinical trials and serving the needs of biopharmaceutical companies and their patients.” Ed Miseta, Executive Editor, Life Science Leader. 

Additionally, PSI placed in attribute awards for Data Quality, Meeting Overall Project Timelines, Technology for Access to Data, Operational Excellence, and Responsiveness. 

In 2018, PSI received four CRO Leadership Awards across Compatibility, Expertise, Quality, and Reliability. The bar was raised high, and it is exciting that the company continues to grow and excel in every aspect of its operational performance.

About PSI: PSI CRO is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents and is known to be highly selective about the work that they pursue. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its customers and its employees.

For Media Inquires: 

Kayt Leonard, Public Relations Manager

919-249-2671 |

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