Case Study

woman with cancer looking at the viewer

Enrolling a Rare Ovarian Cancer Trial 2 Years Ahead of Schedule

At a Glance

The sponsor of a Phase 2 trial in rare ovarian tumors knew enrolling on time with an exceedingly small patient population and a wide global spread would be challenging. PSI worked with the sponsor and leveraged our strong site relationships around the globe, to not only meet but exceed enrollment goals. Ultimately, we supported the sponsor by completing enrollment in nine months, more than two years ahead of schedule, and enrolling ten more patients than initially planned.

enrollment graph with red and blue lines

Phase 2 Rare Ovarian Cancer Study

Sponsor Challenges

As with many rare disease trials, one of the greatest challenges was that there had never been a study that enrolled this specific population, and epidemiology data was likewise scarce. There is also a high administrative burden for rare disease trials that are slow to enroll; locating enthusiastic investigators who will stay motivated throughout the trial is vitally important.

PSI Strategy

1) Finding the right sites and patients

PSI turned to our network of more than 4,000 oncology sites, and positive working relationships with investigators active in gynecological cancer research around the world. This allowed us to identify the ideal sites with a high volume of ovarian cancer patients and key opinion leaders specializing in rare ovarian tumors. Many of these centers met our ideal site profile, as the sites are large institutions that see a high flow of ovarian cancer patients. The data from other countries was perfectly acceptable.

2) The value of site relationships

Because our CRAs understand each site’s organizational structure and can anticipate their needs, PSI was able to provide tailored site support to ensure consistent enrollment. In order to screen and enroll every patient possible, our team worked with the investigators to track and monitor patients with eligible criteria, so that upon relapse, patients could be screened for potential entry into the study.

3) Every patient counts

Enrollment was often a literal race against time. A last-minute eligible patient was scheduled to travel to a site to enroll in the study, but the IRB (Institutional Review Board) required additional changes to the ICF (Informed Consent Form) for this particular study the day before the patient’s arrival. The team was able to get the consent language finalized and resubmitted the same day. The approval came in the day of the patient’s arrival, and PSI worked simultaneously with the sponsor to get the IP-RED approved in time.

Results

  • 25% more patients enrolled than targeted
  • LPI achieved in 9 months
  • Enrollment completed 2 years ahead of schedule

Learn how PSI can support your oncology study at the resources below or contact us today

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Oncology Experience

Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer, and other Oncology indications. 93 percent of PSI’s oncology studies meet or beat projected enrollment timelines.

The Future of Oncology Clinical Research

This white paper provides essential insights for sponsors into the trends with the greatest potential to affect clinical trial design and operationalization.

Enrolling a Rare Ovarian Cancer Trial 2 Years Ahead of Schedule Read More »

nurse holding the hand of an older man

Winning the Biosimilar Race: Trastuzumab Biosimilar Phase III Breast Cancer Study

At a Glance

A sponsor of a global Phase 3 study of a trastuzumab biosimilar came to PSI after falling behind schedule with their current CRO. Drawing on PSI’s biosimilar experience going back to the first such product ever approved by the FDA, we supported the sponsor in recruiting the required 800 patients in just over a year, leading to an EMA approval. Before getting there, though, we had to navigate additional challenges, including an unexpected delay that led to late site activation – just before the summer slow-down.

Phase 3 study in a Trastuzumab biosimilar

Sponsor Challenges

Speed and cost are key for biosimilar development, but development is not necessarily less complex than for a reference biologic. It requires state-of-the-art manufacturing expertise to ensure the biosimilar is “highly similar” with no significant clinical differences in safety profile, efficacy, and potency. Competition for patients against other studies with novel therapeutics often amplifies these challenges.

For PSI’s transition of a global Phase 3 study of a trastuzumab biosimilar in HER2+ early breast cancer patients, it was critical to understand the patient flow from surgery to chemotherapy and back. An additional challenge was that the sponsor’s previous CRO had placed the study primarily in Western countries, where higher standards of care and availability of trastuzumab are common.

How our team made a difference

1) Understanding the landscape

PSI started by thoroughly assessing the country landscape and the product’s reception by sites from our vast oncology network. We selected 100 sites in 10 countries in Eastern Europe, Asia-Pacific, Latin America, and South Africa. The US was also included due to prior expectations from the FDA. The data from other countries was perfectly acceptable.

2) Ready for the green light

Our startup roadmap had to be adjusted when the sponsor put the study on hold for internal reasons, leading to almost half a year of delay in site activation. While waiting for the go-ahead to resume activation, the PSI team prepared contracts ahead of time and had vendors and sites in standby mode. The preparation paid off: as soon as PSI was notified, our teams activated the remaining sites almost simultaneously.

3) Relentless focus on patient enrollment

Because of the delay, site activation occurred just before the summer break, leading to a slow start to patient enrollment. PSI and the sponsor decided to implement several enrollment-boosting measures and organized local investigator meetings for open discussion. A common concern we heard from sites was time and resources, so we optimized site processes to make their work more efficient and focused on the personal relationships of our CRAs and Medical Monitors with investigators and site staff. By optimizing our SDV strategy, close cost control, and the implementation of a blinding system that allowed us to perform drug accountability without the need for a whole unblinded team, we obtained important cost efficiencies.

Program Successes and Outcomes

  • 800 patients enrolled in just over a year
  • Last patient enrolled only 2 months later than initial goal, despite 6-month startup delay
  • Successful FDA inspection and EMA approval

Learn how PSI can support your hemophilia study at the resources below or contact us today

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Oncology Experience

Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer, and other Oncology indications. 93 percent of PSI’s oncology studies meet or beat projected enrollment timelines.

The Future of Oncology Clinical Research

This white paper provides essential insights for sponsors into the trends with the greatest potential to affect clinical trial design and operationalization.

Winning the Biosimilar Race: Trastuzumab Biosimilar Phase III Breast Cancer Study Read More »

Overcoming Global Challenges and Meeting Enrollment on a Phase III cUTI Antibiotic Study

At a Glance

Antibiotic development is notoriously underfunded, so running a pivotal phase 3 study can be a challenge. From the beginning, PSI supported the sponsor by leveraging our global site relationships and experience with pivotal antibiotic trials for the most pragmatic site selection. This helped us enroll the trial at a rate 23% higher than industry metrics in the same indication, with Last Patient In (LPI) occurring during the peak of the first COVID-19 wave. It wouldn’t have been possible without our investment in building close site relationships – because our CRAs act as site ambassadors, sites want to work with PSI and prioritize our studies, even in the midst of a pandemic. 

Antibiotic CS enrollment

Phase 3 study in cUTI - Enrolled 23% above industry metrics in the same indication

Sponsor Challenges

Where did anyone see an easy Phase 3 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.  With a study of this magnitude, ensuring the quality of data globally was also critical.

PSI Strategy

1) Antibiotic Experience

PSI’s strategy for delivering these studies has been tried and tested, ensuring our sponsors the most effective way to deliver antibiotics to market. We also have experience working with BARDA, so we were able to manage the complexities of working with them on this study.

2) The Right Team

PSI invests time and resources to build close site relationships; we empower our CRAs to go further than is typical across the industry. This means sites want to work with PSI, they prioritize our studies, and we understand their preferred methods of working and individual quirks.  

3) Commitment to Quality

The team understood that delivering the data on time was crucial for the study’s success. PSI used a network of regional microbiology labs to ensure the quality of data globally. Despite COVID-19 lockdowns and limited access to sites and patients, our CRAs were able to work closely with site staff to understand each sites individual needs and processes and ensure that all necessary data was collected and cleaned in time to meet key trial milestones.

Results

  • Enrollment rate 23% higher than industry metrics in the same indication 
  • More than 95% of sites enrolling patients 
  • Enrollment of 1,370 patients delivered in 11 months  
  • Screen failure rate of only 5% 

Learn how PSI can support your antibiotic or infectious disease study at the resources below or contact us today

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Infectious Disease Experience

We are an antibiotic powerhouse. 8 out of 12 novel antibiotics approved by the FDA since 2010 used pivotal clinical data generated by PSI sites.

White Paper

Are Your CRO’s Site Relationships Helping or Harming Your Clinical Trial? Solid site relationships are the backbone of successful clinical trials. Without happy, supported sites, enrollment simply cannot happen predictably or within budgetary constraints 

Overcoming Global Challenges and Meeting Enrollment on a Phase III cUTI Antibiotic Study Read More »

nurse holding the hand of an older man

Fast Start-Up & Beating Enrollment Milestones on a Phase II UC Study

At a Glance

When a small biotech approached PSI to run a complex UC study, the sponsor’s concerns were clear: streamline initial set-up, avoid complex vendor management, and overcome multiple operational challenges. PSI was up to the challenge, helping the sponsor achieve 50% enrollment five weeks before their goal and complete enrollment more than five months ahead of schedule.

Ventyx Graph

Phase 2 study in UC - Achieved 50% enrollment five weeks before their goal

Sponsor Challenges

Clinical trials are inherently uncertain, and this study highlighted the inevitability of unforeseen challenges more than most. Along with the impact of the COVID-19 pandemic, this sponsor encountered challenges such as poor performance of a central lab, issues with their IP supplies vendor, medical staff turnover, site activation delays due to equipment set-up, and the greatest challenge of all, a major study redesign and update post startup following FDA feedback.

PSI Strategy

1) Identifying the Perfect Geomix and Ensuring Fast Startup

To ensure fast site startup in the US, PSI identified the central IRB sites with both the right experience and the shortest contract finalization timelines from our database of more than 4,000 global sites. Our Site Qualification Specialists also confirmed sites were properly equipped to use study equipment before the Site Initiation Visit to avoid slowdown during activation. Using VISIONAL™, PSI’s proprietary data-driven feasibility and enrollment forecasting tool, the team identified the best country mix and site profile by collating historical enrollment rates in the given patient population from both internal and external data sources.

2) Invested in Communication

Communication with sites was crucial to enroll patients ahead of schedule. The Study Coordinator organized meetings with each site to discuss the study and each site’s immediate next steps. During the startup process, our CRAs began in-depth training and coaching with all relevant site staff on topics such as best practices for patient consent conversations, raising site awareness, study-specific tasks, and developing a site-specific patient flow to understand the referral process. PSI also developed site-facing enrollment boosting materials and contacted sites weekly to maintain investigator motivation, track screening and enrollment, and investigate any challenges with low enrollment.

3) Next-Level Site Support

Dedicated to building site relationships and understanding the dynamics of each site at the local level, PSI’s Site Support Specialists ensured that each site was supported and had the resources necessary to enroll patients effectively and maximize protocol compliance. The team developed and maintained communication pathways between the combination of physicians/departments, lab specialists, and nurses to facilitate the smooth flow of referrals, and utilized a suite of proprietary PSI tools to ensure sites understood individual stakeholder responsibilities and key study strategies.

Results

With the help of our CRAs, site support specialists, and other team members, PSI closed screening due to high volume even while sites had additional patients. We achieved 50% of the enrollment goal five weeks before the sponsor’s goal and completed enrollment more than five months ahead of schedule. The team also worked closely with investigators to ensure activation timelines were met, helping us achieve the first site activation in just 3.5 months.

“You have met and exceeded my hopes and expectations. I have seen so many challenges, and together we work through them. Speaking for myself and the entire team, we are grateful for this partnership and proud of what we have all accomplished together.”

Learn how PSI can support your hemophilia study at the resources below or contact us today

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

GI Experience

As the need for clinical trials in Crohn’s disease and ulcerative colitis grows, partnering with the right CRO matters more than ever. 100% of PSI’s GI and IBD studies have enrolled on time or ahead of schedule.

White Paper

Are Your CRO’s Site Relationships Helping or Harming Your Clinical Trial? Solid site relationships are the backbone of successful clinical trials. Without happy, supported sites, enrollment simply cannot happen predictably or within budgetary constraints 

Fast Start-Up & Beating Enrollment Milestones on a Phase II UC Study Read More »

Case Study: Achieving Success in the Largest-Ever Study of a Hemophilia Gene Therapy

At a Glance: Managing a 9-study, 21-year program with over 1,240 patients enrolled

PSI supported the sponsor of a program of studies that allowed hemophilia patients access to a gene therapy product for the first time, including the first gene therapy product to be administered in Brazil. By working closely with sites, building trust, and mitigating staff turnover, PSI was able to achieve FDA and EMA approval for nine studies over the course of a 20+ year program, including the largest-ever study of a hemophilia gene therapy.

HemophiliaCSgraph

Phase 3 study in severe hemophilia A

Sponsor Challenges

The first of its kind to offer gene therapy options to hemophilia patients, this extensive nine-study program required stellar teamwork to mitigate challenges from the outset, including high competition for patients, an intensive patient visit schedule, and complex dosing requirements and lab management. Maintaining consistency in trial oversight over the course of two decades to ensure the highest level of management and governance was crucial for the success of such a trial.

PSI Strategy

  • Strong site relationships: PSI has been building hemophilia site relationships for over 20 years. PSI knows the investigators and invests time and resources to build close site relationships, so sites want to work with us and prioritize our studies.
  • Building trust: From the outset, we worked closely with sites, where possible selecting sites that delivered for us on other studies. Additionally, the team implemented meticulous visit planning and site support, using both the Investigator Meeting and co-monitoring visits to build motivation for investigators and help the client gain valuable insights during the program.
  • Low staff turnover rate: PSI enjoys a low turnover rate – just 15% for the key staff on this portfolio. As we retained our staff, there was significant overlap across the portfolio teams, keeping valuable knowledge of the IMP and maintaining site relationships to deliver recruitment that exceeded the global average.

Program Successes and Outcomes

  • 7 successful FDA Inspections
  • EMA and FDA approvals granted
  • Same Project Manager/Project Director for 5 years
  • Creation of client-specific data and budget tracking system
  • 10+ long-term follow-up studies awarded to PSI based on performance

Learn how PSI can support your hemophilia study at the resources below or contact us today

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Hematology Experience

Multiple Myeloma, Lymphomas, Leukemias, and other oncohematological indications. More than 50% of operational staff has hematology and/or oncohematology experience.

Demystifying Biosimilar Development Regulations

Meet our team of experts at this year’s conference where we will be exhibiting at our booth #3352. 

Case Study: Achieving Success in the Largest-Ever Study of a Hemophilia Gene Therapy Read More »

Case Study: How VISIONAL™ is Helping to Accurately Predict Study Enrollment Timelines

At a Glance: AI and ML-powered insights for your next trial

A sponsor of a challenging breast cancer study needed to identify the optimal mix of countries and sites with similar experience and access to a hard-to-recruit subpopulation of breast cancer. Using internal and external data sources, PSI’s VISIONAL™ platform compared thousands of feasible country-site combinations and recommended the optimal enrollment scenario to meet the sponsor’s timelines and cost constraints.

Trial Enrollment Recommendations from VISIONAL™
key metrics for VISIONAL case study. 520 patients with heart in hand symbol. 126 trial sites with a target in a human head symbol. 7 countries with a world symbol. all in white text.

Sponsor Challenges

The study targeted patients pretreated with recently approved drugs. Our key criteria for country and site selection included local standards of care, historical performance in the indication, and current competition. After the initial planning had begun, the sponsor also requested 20% of patients from Latin America.

How VISIONAL™ Helps Make Strategic Decisions

Working with internal and external data sources and KOLs, PSI feasibility team quickly pulled all available data on standards of care, site performance, and historical enrollment rates, carefully curated for similarity. The dataset included 40+ countries in North America, South America, Europe, Asia-Pacific, and Africa. Using this trove of data, VISIONAL™ compared hundreds of country/site combinations, taking into account study costs and probability of success.

We were able to easily adjust the constraints for regional patient quotas as well as additional requirements from the FDA and EMA after two rounds of protocol review.

Results

1. Optimal Enrollment Scenario

VISIONAL™ recommended the most optimal combination of sites, countries, and timelines based on the current landscape and historical benchmarks, while taking into account all constraints set by the sponsor and the FDA.

2. Cost vs. Speed
The system recommended the fastest and most cost-efficient scenario within the sponsor’s budget range and timelines. We were also able to quickly evaluate alternative options:

  • Faster scenarios with an acceptable risk level
  • Longer but less expensive scenarios
  • Scenarios that buffer for unexpected delays

3. Customizable and Adaptive Reports
The initial work done during the planning stage also provided the sponsor with peace of mind during the study launch with the ability to rapidly model new scenarios based on additional constraints/new requirements.

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Therapeutic Areas

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Case Study: How VISIONAL™ is Helping to Accurately Predict Study Enrollment Timelines Read More »

up close image of a small clear vial, a CT scan of a brain and a stethoscope

Case Study: Phase 3 Radiopharmaceutical Clinical Trial in Oncology

At a Glance: FDA Approval in 4 Years

Radiopharmaceutical clinical trials face a host of logistical challenges from startup through the clinical phase. A sponsor of a pivotal Phase 3 prostate cancer study investigating a radiopharm product approached PSI for support based on our experience and established network of over 400 global radiopharmaceutical sites. By working closely with our sites and vendors, PSI met or beat all critical milestones, helping our client secure FDA approval for their radiopharmaceutical product in under four years.

graph representing predicted vs. actual patient enrollment and patient screening numbers
Patient Screening and Enrollment Numbers
key metrics for radiopharmacy case study. 1200 patients with heart in hand symbol. 860 trial sites with a target in a human head symbol. 10 countries with a world symbol. 90 trial sites with a hospital symbol. all in white text.

Sponsor Challenges

The major challenges in global nuclear medicine trials include the complexity of regulatory requirements in each country and the necessity for experienced, highly trained sites either within close proximity to the material’s manufacturing site or with the ability to provide at the site level. The investigational product in this study had a half-life of three days, necessitating diligent time management and site engagement to deliver the study on schedule.

PSI Strategy

To make sure eligible patients didn’t miss these three-day windows, PSI’s CRAs encouraged sites to maintain frequently updated pre-screening logs and regularly discuss the pool of potential patients with the investigators. We also worked closely with sites and the manufacturing facilities to time the inclusion of each patient appropriately, especially around local bank holidays when a manufacturing facility would not be available.

Results

1) Expedited Study Timelines
PSI met or beat all critical milestones during the study, including achieving FPI in the US in less than 3 months and completing NDA submission one month ahead of schedule.

2) 99% Enrolling Sites
Only one out of all initiated sites did not enroll a patient.

3) Successful Regulatory Approval
After passing three FDA inspections without major findings, PSI’s regulatory experts helped our client secure FDA approval in under four years.

“I would personally like to acknowledge and thank the entire PSI team and leadership for the dedication, perseverance and determined support that supported the early completion of the study. Your team have showcased all the capabilities and attributes of a best-in-class CRO for project delivery.”
abstract background purple cells
--Global Head
External Relationship Management

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Therapeutic Areas

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Case Study: Phase 3 Radiopharmaceutical Clinical Trial in Oncology Read More »

red blood cells under a microscope viewing with a purple dye contrast

Case Study: Optimizing Feasibility and Start-Up for a Phase III HemOnc Clinical Trial

At a Glance

No trial is ever easy. But with the continued effects of the global pandemic and the war in Ukraine, the sponsor had larger than average challenges. Nonetheless, PSI managed to demonstrate swift feasibility and start-up ahead of schedule, leveraging site relationships, and fostering team consistency and stability. In the end the study completed enrollment of nearly 900 patients on time at as many as 370 sites all around the world. Italy and Australia showed up as the top enrolling countries.
graph depicting planned vs. actual patient enrollment for the hemonc case study. There is a red and blue line
Patient Enrollment Numbers
Key metrics for HemOnc case study 900 patients enrolled with heart in hand symbol. 425 sites activated with target in a persons head symbol. 30 countries with a world symbol.

Sponsor Challenges

Enrolling over 900 patients and in a clinical trial of this complexity would pose a challenge even in the most mundane of years. Add to that continual pandemic consequences and a global conflict, the stage is set for every possible delay and communication breakdown. The sponsor needed a CRO willing to tackle an aggressive recruitment plan and provide a solid partnership in order for the trial to succeed.

Start-Up in Sync

Staying on time means starting on time. Working closely with sites to understand how the pandemic affected their ability to meet site activation, PSI offered them several technical options that allowed for remote site selection visits. PSI managed to identify over 3000 sites and select about 500 sites 3 months ahead of schedule.

Additionally, feasibility projections were actually reflected in enrollment, not merely a best-case scenario or wishful thinking. This is due in large part to knowing the sites. Today, PSI would have also added machine-learning-powered tool, VISIONAL™, to generate the most optimal enrollment scenarios that could potentially further reduce the study time and cost.

Racalibrating the Geo-mix

Not every CRO can offer flexibility and adaptability, especially in a short amount of time. During enrollment, a change of strategy on the sponsor side called for more sites, and swiftly. In order to do this, countries with initially smaller projected sites and patients had to ramp up with little to no interruption. The only way this could be accomplished was with previously established solid global site relationships and coordination and stellar communication on every level of the study team.

Managing Motivation, Staffing, & Velocity

To motivate teams on a country level, PSI staff focused on maintaining a sense of competition between teams. This helped create a friendly sense of excitement as countries saw their recruitment numbers grow.

Continuity of the study team also played an enormous role in the study’s success. This not only helped keep the study on track when the client had changes to their own staff but provided a sense of consistency and reliability throughout the course of the trial at every level. Key roles project supervisor, project manager and other key staff stayed on for the whole of two years of study duration, something almost unheard of in this ever-changing industry. They are still with PSI running the trial as we write these lines.

The PSI Advantage

For the sixth year in a row, PSI CRO has been named a CRO Leadership Award winner in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small pharma) respondent group. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR Reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral.

Oncology Experience

Including multiple myeloma, lymphomas, leukemias, and other oncohematological indications.

 

ASH 2023

Meet our team of experts at this year’s conference where we will be exhibiting at our booth #3352. 

 

Case Study: Optimizing Feasibility and Start-Up for a Phase III HemOnc Clinical Trial Read More »

Strategies for Working with NGS Testing on Site in China

Did you know that NGS testing in China can be expedited with the right site relationships? 

As treatment options move towards enhanced personalization, NGS testing, or specific gene mutation testing, has become increasingly common as part of modern oncology and hematology clinical trials. When PSI Shanghai was contacted about a specific oncology trial requiring NGS testing, the team was able to contact 24 sites with relevant indication experience, and within 3 days, received interest from 15 of those sites to participate. 

In order to accelerate patient enrollment, PSI engages a trusted network of highly qualified sites to ensure that each trial’s needs are met with specific experience. Learn more about NGS testing in China with Lisa Lu, Country Manager.

If you have a phase 2/3 clinical trial requiring NGS testing, consider clinical trial sites in China. Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Discover more about our oncology and hematology experience here or contact us to speak with an expert today.

Transcript:

Did you know the NGS testing status in China?
Modern Oncology and hematology trials often require specific mutation testing, as we all move to a more personalized
medicine in time.
While this NGS technology is well established in China, it is not used in every study yet.
We still have capacity here. Let me share with you some recent cases.
We recently had a request for a specific oncology trial to be run in China. The protocol required sites being able to run the
NGS testing in screening phase. PSI’s Shanghai team contacted 24 sites with study experience in this indication.
Overall, the sites’ attitude was positive.We only had 3 days to check our sites. Among all of them, 15 sites expressed immediate interest and had the relevant
NGS experience and equipment.
The results show that NGS testing is not a show stopper for any modern trials which need this measured in China.
Looking forward to seeing you in Shanghai.

Strategies for Working with NGS Testing on Site in China Read More »

How to Boost Patient Enrollment in a Global IBD Trial

For one of the largest-ever global IBD trials, we knew our sponsor’s success depended on identifying the right sites and keeping them engaged.

Details:

Therapeutic Area: IBD

Geography: 40 countries

Sites: 400

Patients: 800 (planned)

Current Status:

  • Patient enrollment on schedule
  • PSI is on track to enroll 500 patients by year-end

How to Engage Investigators & Patients in the Highly Competitive IBD Landscape

After a large pharmaceutical company delivered enrollment 60 days ahead of schedule for a Phase 2 inflammatory bowel disease (IBD) study with PSI CRO, the sponsor faced a new challenge: one of the largest-ever IBD programs in the same indication. Competition for IBD patients is fierce, and we knew success depended on not only identifying the right sites but also keeping them engaged throughout the duration.

The sponsor engaged PSI to manage 400 sites and enroll 800 patients across 40 countries. With the length and size of the study, many sites went silent after the initial excitement. The onset of the COVID-19 pandemic introduced a whole new set of extraordinary challenges, which was especially noticeable during the summer months – already a typically slow period, but also when many countries implemented additional restrictions to slow the spread of new variants that made enrollment even more difficult.

To re-energize the study team and keep enrollment on track, the sponsor introduced a new incentive campaign with PSI modeled after the Summer Olympics to foster a sense of friendly competition.

3 Steps to Empower Your Sites

  1. Create a compelling, inclusive campaign to motivate sites

PSI divided the study teams to stand for their respective countries and introduced the following scoring system:

  • Gold medal: Awarded for every subject randomization
  • Silver medal: Awarded for every subject screening
  • Bronze medal: Awarded for every subject rescreening

The project team developed creative materials and branding to engage the teams during the campaign and made sure that countries of all sizes stayed visible within the competition thanks to an averaged rating system.

  1. Invest time into building close relationships with the site teams

To be truly patient-centric, a CRO needs to first be site-centric. Our mission is to make the site’s life in clinical trials as trouble-free as possible. It’s not easy, because clinical trial protocols are typically overcomplicated by all sorts of requirements that add work to the site staff already exhausted by routine medical practice. That’s why we are focused on building site support processes, working closely with the site staff to prevent and fix any signs of screening and enrollment delays.

PSI works carefully with each investigator to increase the percentage of patients entering the study, providing training and resources so the site teams understand the best moment to screen patients for the study and that screen failure patients could be reassessed. The project team provides extra support to sites and patients with personal protective equipment, implements additional procedures for direct shipment of the drug to patients’ homes, identifies a big network of local labs to minimize trips during the pandemic, and arranges comfortable and safe conditions for patients’ travel or travel reimbursement.

  1. Build on a long-standing partnership

With the same leadership team in place since 2015 for the program, including the same Global PM and Co-Manager from the Phase 2 Study, the PSI teams draw on their experience from previous studies for this client during the competition. PSI Country Managers and Clinical Operations colleagues are also engaged to help the project teams come together to meet a common goal. It’s great to have a stable global team on such a complex project.

Sign up for more IBD insights from PSI CRO.

 

How to Boost Patient Enrollment in a Global IBD Trial Read More »