Regulations

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 »

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FDA Seeking Comment on New Draft Guidance on Diversity Action Plans

Increasing diversity within clinical studies, especially for historically underrepresented populations, is one of our industry’s most critical challenges today. The U.S. Food and Drug Administration (FDA) has released a long-anticipated draft guidance to assist sponsors in developing detailed strategies for reaching this key goal. Released on June 26, the draft guidance Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies is now open for comment for 90 days.

What is the purpose of the draft guidance?

The guidance provides clarity for sponsors, researchers, and stakeholders in developing Diversity Action Plans, underscoring the importance of their role in this vital initiative. “Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”

The guidance also encourages sponsors to consider dimensions of diversity beyond the usual definitions, such as age, ethnicity, sex, and race. Studies should seek to enroll and retain populations that are representative of the patients who will be treated if the drug is approved.

What does the draft guidance include?

The guidance covers such topics as:

  • The format and content of Diversity Action Plans, including data-based rationale and goals for study enrollment separated by population and how the sponsor plans to meet those goals and measure progress
  • The types of medical products and clinical studies that require a Diversity Action Plan
  • Timing and process for submitting plans to the FDA
  • The agency’s criteria and process for evaluating waiver requests for required plans

Which trials does the guidance cover?

As required by recent provisions of the Federal Food, Drug and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA), the requirement to submit Diversity Action Plans applies to phase 3 clinical studies and, as appropriate, other pivotal clinical studies of a drug or biological product. The requirement also applies to certain device trials, including those intended to serve as the FDA’s primary basis for evaluating safety and effectiveness and benefit-risk determination. Where not required, the FDA strongly recommends that sponsors implement a diversity strategy whenever possible, including in early-phase studies.

When will the guidance be in effect?

These new requirements will apply to all relevant trials that start enrollment after 180 days from the final guidance publication date. However, sponsors should begin planning early to ensure compliance.

How can I learn more?

For more information on whether your study requires a Diversity Action Plan and what should be included, schedule a meeting with PSI. PSI specializes in pivotal Phase 2 and 3 trials and has a global regulatory team to help you ensure compliance with the FDA and other key regulatory bodies. In addition, our machine-learning-powered tool VISIONAL™ makes it easy to model the optimal scenarios for enrolling key populations by comparing hundreds of country and site combinations, their budgets, and the probability of success within just a few minutes. To learn more, contact us today.

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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.  

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What to Know About Brazil’s New Clinical Research Law

On May 28, 2024, Brazilian President Luiz Inácio Lula da Silva approved new Law No. 14.874, containing new rules for human research. This milestone is the culmination of nearly a decade of negotiations since the original bill, PLS 200/2015, was presented in April 2015.

The new legislation, which takes effect on August 26, 2024, is set to provide a significant boost to sponsors conducting clinical trials in Brazil, offering enhanced security and certainty. Here’s a comprehensive look at the key aspects of this legislation.

  1. A streamlined review process: In the past, Brazil’s approval process was complex, often requiring double approvals by both local ECs and a federal review board, the National Research Ethics Commission (CONEP). The new law simplifies this process by stipulating that ethical analysis be conducted in a single instance by the EC, thereby reducing the number of review steps.
  2. More predictability for startup timelines: The legislation establishes new mandatory timelines for review by Ethics Committees and the National Health Surveillance Agency (Anvisa). Ethical review cannot exceed 30 business days from the date of acceptance of all research documents. If the EC requires additional information or documents from the sponsor, this deadline can be suspended for a maximum of 20 business days. Anvisa’s analysis of primary petitions for trials with human beings is not to exceed 90 business days.
  3. Revisions to the mandatory post-trial access requirement: The law provides greater clarity on conditions for access to the investigational drug post-trial, and when needed, provision will not be required after the product is made available by the National Health System.

With the approval of this new legislation, clinical development activity in Brazil is likely to increase, providing greater access to trials for patients within the country and accelerating the availability of new treatments.

PSI CRO has a long history of conducting trials in Brazil, including administering the country’s first gene therapy. Due to our site relationships, our startup timelines for many countries in Latin America are already comparable to those in Europe. To learn more about Law No. 14.874 and whether Brazil makes sense for your pivotal trial, contact us today.

Reviewed by:

Oscar Podesta, Head of Latin America, Country Management

Julia Begalli, Head, Regulatory Affairs, Latin America

Livia Constantini, Regional Project Lead, Latin America

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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.

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Strategies for Expediting Study Startup in Australia With Barrie Koh

Did you know that Phase 2 and 3 study startup times in Australia can be expedited with the right site relationships? In order to accelerate the first patient in, PSI engages private sites and medical centers to ensure an average startup timeline of only five months. Learn more about study startup in Australia with Barrie Koh, Country Manager.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

Hi, I’m Barrie. Did you know that Australia is quick to start up?

Everyone in the industry knows that it is easy to get an approval for an early-phase study in Australia. It is supported by streamlined regulatory processes, and you just need fewer documents for submissions. What most don’t realize is that startup in Phase 2 and Phase 3 isn’t that different.

The challenge is that most clients have a habit of going back to the same key opinion leaders or the huge institutions. they have lots of studies and they are heavily bureaucratic. To get to the first patient in quickly, PSI has been engaging the private sites, which are much more agile, only working with four to five huge private medical centers and a dozen more smaller sites.

With this particular approach, five months is feasible and it is consistent across all phases, all therapeutic areas and drugs classes. To cite you an example, in a recent microbiome study, we actually managed to achieve the first patient in in five and a half months at a private site down in Sunshine Coast. And this came in two weeks ahead of our planned first patient in.

Another example is a gene therapy study that we’re currently running. We were the first CRO to apply for a gene therapy license (in Australia). So we actually worked with each other to try to move this forward and this was done under four months itself and ever since then, we’ve completed four more gene therapy studies.

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How to Apply for Phase 1 and Phase 3 Studies in China at the Same Time With Lisa Lu

Did you know you may be able to run Phase 1 and Phase 3 studies in China in parallel, particularly for urgent medical needs?

Hear Lisa Lu, PSI CRO’s Country Manager in China, discuss how to determine if your study may qualify and how PSI’s local experts can help.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

Hello, my name is Lisa Lu. I’m the country manager for PSI in China and I’m located in Shanghai. Let me share with you some relevant aspects for running clinical trials in China.

Did you know that for new drugs coming to China, it is needed to conduct a PK study in a Chinese population locally? One can apply for an IND for Phase 1 and Phase 3 studies at the same time.

Based on NMPA’s feedback, you can potentially run Phase 1 and Phase 3 studies in parallel. Urgent medical needs like hematology studies, and lethal diseases without any drugs available at the moment, have a higher chance in running Phase 1 and 3 studies at the same time.

Usually, a PK study needs 20 to 30 healthy volunteer subjects or patients, depending on the different indication and medicine.

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Transition Your Ongoing Study to EU Clinical Trial Regulation in 3 Steps

After being adopted by the European Parliament in April 2014, the European Union’s Clinical Trials Regulation (Regulation (EU) No 536/2014) officially took effect on January 31, 2022. The regulation aims to improve the harmonization of the approval process for clinical trials and make the region more attractive as a destination for clinical research.

If you are a sponsor of active clinical trials in the European Union, you may have additional responsibilities under the new Clinical Trials Regulation. But don’t worry. Here are the steps for transitioning an active clinical study in the European Union to the new requirements under the EU Clinical Trial Regulation. For a more in-depth look at the changes, you can read our new white paper A Guide to the EU Clinical Trial Regulation: How to Ensure Timely Transition for Current Studies.

Steps for Transitioning Ongoing Studies

  1. Sponsor Evaluation
    • Evaluate your clinical trial’s current compliance with the Clinical Trial Regulation and identify the need for transition
    • Determine whether the dossier needs to be harmonized between Member State Committees
    • Confirm if the clinical trial is eligible for transition (no pending/ongoing assessment in any EU or EEA countries)
  2. Harmonization
    • Harmonize dossiers via SA application according to CTD
  3. Transition
    • Make formal application for transition (simplified dossier, no re-assessment!) in the new Clinical Trial Information System
    • A new cover letter and new application form module are required to be completed in CTIS (see Figure 1)
    • For multinational clinical trials: Sponsor’s declaration that part I/part II documents do not contain significant differences/are identical to the versions approved by each Member State (as applicable)

Figure 1. Documents required to be uploaded in the CTIS for transition

The standard timeline for the review of the transition application is 60 days. During this period, the trial cannot be amended. If and when the trial undergoes the next substantial modification following the date of applicability, the full requirements of the new CTR will apply.

As a privately owned and operated contract research organization headquartered in Switzerland, PSI CRO has continuously monitored and adapted to the changing European regulatory landscape over the last 25 years. Drawing on this experience, we can offer a unique perspective on preparing for this shift in how clinical trials are conducted in the EU. Click here to read our new white paper or get in touch with one of our regulatory affairs experts.

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A Guide to the EU Clinical Trial Regulation: How to Ensure Timely Transition for Current Studies

With the European Union’s Clinical Trial Regulation coming into effect on January 31, 2022, we know there are many questions when it comes to what’s changing and what you need to do to comply. That’s why PSI CRO, drawing on our 25 years of experience managing studies across the globe, is sharing our insights in a new white paper.

In A Guide to the EU Clinical Trial Regulation: How to Ensure Timely Transition for Current Studies, you’ll learn:

  • The new elements introduced by the EU CTR
  • The applicability for current studies
  • How to transition your study to the new requirements

Click the image below to start reading or download a copy.

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