5 Tips: What Can You Do This Year to Get Your Study Ahead in 2021?

November 23, 2020

It’s no secret that COVID-19 has caused an unprecedented disruption for sponsors, investigators, and patients in 2020. According to a recent article in Nature Reviews Drug Discovery, “around 1,000 organizations have reported trial disruption, consistent with a reported ~80% decrease in new patients entering trials per site in April 2020 compared with April 2019.” Although there has been a slight trend toward trial resumption, many trials continue to suffer from slow patient enrollment. As a recent white paper presenting the findings of Veeva Systems 2020 Study Start-Up Pulse Report highlights, organizations have an urgent need to streamline study start-up processes. As we inch toward 2021, there is an apparent desire to start the first quarter off strong, but as this past year has highlighted, COVID-19 will continue challenging study start-up moving forward.

So, what have we learned so far? And what can we do now to get you ahead moving into the new year? Here are our tips on building momentum as we round the corner of the final quarter to set your trial up for success.

1. Be Aware of the Competitive Trial Landscape

GlobalData recently reported, “for trials currently experiencing slow enrollment, one-tenth of these are specifically due to the unavailability of sites and investigators.” We’ve witnessed this scarcity firsthand as many sites you’d usually rely on are fully booked or turning down sponsors with unrealistic budgets or that take too much time negotiating budgets. Scarcity breeds competition. You cannot afford to lose valuable time and money invested in finding a site, filling out the questionnaire, and conducting the initial site visit for everything to fall through during slow budget negotiations. If you’re unwilling to create realistic site budgets, or move quickly in this competitive trial landscape, there will be someone behind you that will be.

For studies in start-up, PRC Clinical works to nurture existing relationships with sites to determine which will be the quickest for us to activate when needed. We see value in partnering with sites that can now reach your milestones, including first patient in, knowing that there are often rounds of funding dependent on meeting this target. We recognize that partnering with a site that can perform and leverage competition between sites is paramount, not only to find the ideal one for your trial but to determine which will be the quickest to activate. Generally, these will be smaller commercial sites without the internal bureaucracy you’ll find at large academic institutions that take longer to get up and running.

For ongoing studies, we recommend pausing additional site activations between now and the end of the year. Instead, try focusing on making your existing sites even more effective to maximize enrollment and increase engagement.

2. Evaluate for Your Indication

As mentioned, we are experiencing unprecedented competition and site scarcity. Studies have shown that “poor site choices can lead directly to study failure, or to a costly exercise of including additional study sites, amended protocols, and the potential for patient populations receiving different treatment regimens.” This underscores the importance of a site feasibility assessment to uncover if a site has access to your patient population profile, staffing with experience in your indication, the proper facilities to administer your treatment. And additional factors, including an evaluation of concurrent trials in the same indication or those targeting the same population profiles that are ongoing or scheduled to start during study conduct.

A feasibility assessment is a primary example of how you can initiate your trial to identify and determine the risks at different institutions. Understanding that there are many study-specific factors associated with site selection, it’s never too early to begin assessing sites to determine if you’ll meet your projected enrollment capabilities for your indication. We also recommend prepping site contract templates, budget templates, and project plans now. These are low-cost options that are easy to implement and maintain if additional changes are needed.

PRC Clinical can develop robust feasibility questionnaires and templates to help uncover many of the study-site-related factors that are essential for your trial’s success. Carefully crafting site selection questionnaires aimed at finding site capabilities, including staff qualifications for the studied indication, remote technological capabilities, and access to key patient populations within your indication, can help ensure that the sites are ready to begin receiving patients by the time your trial is ready to start.

3. Evaluate your Existing Data

It may seem obvious, but one of the most powerful tools you have to inform future tactics is your existing database, including previously utilized sites and patient population information to check inclusion/exclusion criteria. Pharmaceutical Outsourcing reports a data-driven feasibility assessment can “improve the probability of getting the right sites to improve the recruitment performance.” Where a traditional approach to identifying sites has often relied solely on feasibility questionnaires, a data-driven approach seeks to supplement a questionnaire and drive efficiency, especially during patient recruitment.

Also, partnering with a CRO with its own robust database of potential sites and patient population metrics helps make better-informed decisions to maximize your trial’s success. PRC Clinical regularly updates our internal database with new sites and nurture relationships to accelerate trial start-up. There are also many free and paid tools, such as:

• Site network organizations
• Online and offline directories
• Publications of recent clinical trials in the studied indication
• gov postings

4. Re-examine Your Protocol Through COVID Glasses

Proper site selection is not the only factor for site performance and study success. External forces and challenges often affect study conduct, and COVID is no exception as it requires additional planning and mitigation strategies. In March, the FDA released updated guidance in clinical trial conduct, recognizing that “protocol modifications may be required, and there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 public health control measures.” Additional suggestions include:

• Alternatives to in-person safety assessments such as phone contact, virtual visits, alternative locations for assessment, including local labs or imaging centers.
• Direct-to-patient investigational product delivery.
• Efficacy endpoint data collection.
• Replacing on-site monitoring with centralized or remote monitoring.
• Additional safety monitoring of trial participants if the trial is halted or treatment is discontinued.

At PRC, we understand that things are rapidly changing. It’s critical to evaluate trial protocols to build more flexibility for sponsors who are beginning to enroll once again or for those in study start-up. Our experts can work hand-in-hand with you to carefully evaluate how patients are treated during your trial and determine the best tactics for your trial, whether incorporating telemedical visits and remote monitoring or holding an advisory meeting to reevaluate current protocols starting with the best-known knowledge and the threshold for their primary endpoints. As we move forward, it is vital to proactively recognize that things have changed and look at your primary endpoints and criteria now, so your enrollment isn’t impacted in the future.

5. Start Now to Enter 2021 With Momentum

As suggested in our previous blog, Keeping Trial Momentum During COVID and Beyond, you should focus on keeping the balls in the air and rely on your team to keep moving. If your goal is to enter 2021 ahead of your competitors, there’s no better time to get started than now. If the question is, should I do this myself or should I use a CRO, there are certain things you’re going to get that can move you toward your goals. When you partner with PRC Clinical, you can rely on our services to keep trial momentum moving, including:

• Validated E Signature Platforms, eTMF and CTMS
• Site Selections for Sites with Virtual Capabilities
• Quality Oversight System
• Expert team with the right expertise for your patient population
• Experience managing sites for faster start-up

With over 15 years’ experience, PRC Clinical has specialized in working hand-in-hand with sponsors, sites, and investigators to accelerate study start-up across various therapeutic areas, including regenerative medicine, CNS, ophthalmology, and more. As the pandemic began to unfold, we started taking steps to proactively prepare you to meet the ongoing challenges head-on through our robust experience and high-touch services.

As site management is even more critical in the wake of COVID-19, we have continually nurtured relationships at the site to understand their capabilities and patient population demographics fully. Whether you’re developing innovative biotech, looking to streamline your next clinical trial, or need help managing sites, you need a CRO with the agility and tenacity to creatively solve your critical research challenges whenever they arise.

When you need specialized expertise to set you up for success in 2021, you deserve TLC from PRC.

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