Clinical trial recruitment has been understandingly difficult for the past fifteen months. Isolation and quarantine have kept patients (not to mention site and trial staff) from being able to undergo appropriate screening and enrollment measures. Because of this immense issue, many trials have been paused (or worse, stopped all together). Now that the world is reopening and taking a sigh of apprehensive relief, how do we get back on track to begin moving full steam ahead for patient recruitment?
The CDC has recently announced the laxing of many COVID-19 restrictions, including vaccinated individuals no longer requiring masks and indoor/outdoor capacity maximums increasing. While this is a positive move forward as the world gets a better handle on the pandemic, there are still apprehensions and concerns on the forefront of everyone’s minds. Is this really safe? Should we actually return to the normalcy of pre-COVID? Are sites set up to handle the world opening back up?
Addressing these concerns as a site is difficult, demonstrated by global clinical trial completion rates dropping to 13-23%1. Managing multiple trials and recruitment efforts even before the pandemic was quite a task for study coordinators, and this new pile of issues being thrown at them today makes things even more difficult. Studies are opening back up at once and sites are struggling to balance them all. Study coordinators and PIs desperately need a strong support system to overcome these hurdles, as many sites face the staffing losses they experienced throughout the pandemic.
2
This shift back to a new normal has many sites and sponsors wondering what they should do to get their studies back on track. If you find yourself falling into this category, know that you aren’t alone. Over the past few months, our team has seen similar challenges across all studies we are supporting:
To overcome these challenges, CSSi has helped our clients focus on the following:
One of the biggest challenges that we are seeing is the lack of resources at the site level to dedicate to patient recruitment– both in staff and time. Study coordinators are juggling many studies all re-opening at once and their attention is getting pulled in many directions. Sites need a dedicated resource to help them manage recruitment efforts for their studies.
CSSi is prepared to address the evolving patient recruitment support needed for both domestic and international clinical trials. Our full-service model provides a suite of services to make your study top-of-mind and answer the recruitment needs of all sites: patient and physician-facing recruitment material development, study website and pre-screener development, digital/social media and traditional advertising placement, and customized site support by our Local Enrollment Specialists. Our LES team can assist with referral management (patient follow-up, secondary patient pre-screening, study visit scheduling, reminder calls and more), chart reviews, medical professional outreach, community awareness, and advocacy outreach. We are set up to either provide a full-service program for your studies or use a plug and play model to fill in any gaps to your current recruitment strategy. Our ultimate goal is to make your study a priority at each site we support and to ease the recruitment burden on the study coordinator, so their attention can be devoted to other important study tasks.
Setting your sites up with support from CSSi will lead to an increase in site engagement, study interest and referrals/randomized patients. We understand the challenges facing researchers and clinical sites today no longer mirror the world fifteen months ago, and our team is prepared to provide the solutions you need to overcome them.
If your studies and sites are significantly affected by the pandemic and need support, reach out to CSSi today.
1https://www.sciencedaily.com/releases/2021/04/210407174310.htm
2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538012/
Gene and cellular therapy are novel treatment methods that are avidly being studied in a realm of different indications including oncology, neurology, rheumatology, pediatrics, and more. As of 2023, there are over 1,500 gene/cellular therapy trials actively enrolling with a majority being in Phase 1 and Phase 2 stages.
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During the COVID-19 pandemic, many clinical trials were halted or stopped altogether due to the inability to recruit and screen patients. Much of this was due to a centralized study set up, where patients were required to appear in person for screening and secondary study visit activities. As the pandemic progressed...
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Marketing and advertising are an art form. And as is true of all art, it evolves and adapts to the world around it (And enter the famous question: Does art imitate life or does life imitate art?). Reaching patients for clinical trials is quite a task. Creating awareness, providing education, and garnering true interest is a multi-pronged approach that requires an in-depth understanding of the needs and communication...
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The health and well-being of all persons regardless of race, religion, sexual orientation, or gender is integral to public health. As a nation, the United States is slowly improving and becoming self-aware of the maladaptive behavior towards its minority citizens both past and present.
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Clinical trial recruitment has been understandingly difficult for the past fifteen months. Isolation and quarantine have kept patients (not to mention site and trial staff) from being able to undergo appropriate screening and enrollment measures. Because of this immense issue, many trials have been paused (or worse, stopped all together).
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We have all heard these statistics before: 85% of all clinical trials fail to recruit enough patients and 80% are delayed due to patient recruitment problems.1 This makes selecting the right patient recruitment partner such an important part of setting your study up for success.
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Clients often ask if we are able to provide recruitment reporting and metrics. What’s our answer? Yes, we’ve been doing it for years!
When you hire an agency to support your patient recruitment and retention efforts, you deserve to know what they are doing and if it is working.
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Patient recruitment is often a time-consuming and high-cost step in completing your clinical trials. Your marketing team will have to develop the correct study message and a strong call-to-action to get people motivated to see if they prequalify. You must strategically target your patient population and generate interest in participation among this audience.
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The COVID-19 virus has significantly changed the way the world operates. It has caused unprecedented interruptions to many industries and businesses around the globe, and clinical trials are no exception. New guidelines have been issued by the FDA regarding clinical trials, which could have a significant impact on study enrollment and patient retention.
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As you begin the patient recruitment process for your study, it can be tempting to put all of your money towards one method. You place all bets on digital advertising because that generated the most referrals during your last study. What happens if digital doesn’t perform for you this time? It’s best to spread your advertising budget out over a number of recruitment methods. This gives you the ability to truly test what is most effective.
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Identifying and implementing ways to increase diversity in clinical trials is a growing topic in the industry. Almost 40 percent of Americans belong to a racial or ethnic minority, but roughly 80-90 percent of participants in clinical trials for new drugs are still disproportionately Caucasian.1
In order to make sure drugs and treatments are safe and reliable to all people, there needs to be a better representation
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You’ll often be faced with more work than there is time each day. Meeting with patients, scheduling appointments, fully informing patients at time of consent, training study staff, conducting study procedures, working with sponsors, advertising for the study and recruiting patients... the list goes on and on.
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We all see others do it, and we probably experience it ourselves it every day.
Watching videos and tv shows on devices other than the TV in the family room, catching up on your favorite sitcom on-demand because you weren't home to watch it at 8pm when it originally aired, or streaming videos on YouTube to pass time. As the years go by, technology and media are changing – and so is how we are using them.
Each year, $1.89 billion is spent on patient recruitment for clinical trials.1 With a 30% average dropout rate across all clinical trials, many pharmaceutical companies are spending a large amount of money to recruit patients who aren't staying enrolled in their trials.
Needed study data for regulatory submission and the overall success of a clinical trial depend largely on study participants fulfilling their roles...
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One of the top places sites look for (and sponsors depend on) when recruiting patients for clinical trials is their database of patients. It has been a go-to method of recruitment for years. In a recent study, however, only 27% of sites report being fully satisfied with their current recruitment methods, including site database searches.1
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Within the world of patient recruitment for clinical trials, delayed timelines and unforeseen budget issues are often the norm. But, what if just a bit of strategic planning up-front decreased the possibility of these barriers?
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As a research study is in its early planning phase, sponsors and CROs dedicate a significant amount to identifying and selecting the research sites who have the ideal database of eligible patients for their study.
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As a sponsor, CRO or site, there are a surplus of patient recruitment companies you can turn to when you need help finding patients for your studies, and that number grows higher every day. Most of these companies offer a niche service, but very few are a full-service, global recruitment agency like ours.
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We've all heard it before: "traditional advertising is dead." But if that were true, why are we still seeing commercials on TV, hearing ads on the radio, and seeing billboards on the highway during our morning commute?
Because it's not true! Traditional advertising is still very much alive and used by some of the largest companies worldwide.
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If you’ve been following along with our past blogs, you have gained insight into:
You're going through the checklist of everything needed to get the awareness efforts for your study up and running:
You have:
There are about 93 million Americans searching online for information related to a health-related topic, with 63% of those individuals looking up a specific disease or medical problem. In fact, looking for health or medical information comes high on the list as one of the most popular activities people do when they are online.
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Let's imagine two different scenarios:
A: You're sitting in a doctor's office, and you see a poster for ACN-053-2414, a clinical trial testing medication for acne in adults.
B: You're sitting in a doctor's office, and you see a poster for the Face It Acne Research Study, a clinical trial testing medication for acne in adults.
