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. There are currently 27 FDA approved gene/cell therapies in the United States, with a hopeful expectation of an additional dozen more therapies to be approved sometime this year.
As success continues to grow in this new field of therapeutics, there are still many concerns and unknowns about gene/cellular therapies. At a fundamental level, it can be quite scary for patients looking for new options. Not only are there many new variables that patients may not be used to, but these trials also often require a long participation time and many clinic visits which can be a strain on the patient.
Recruiting for potential gene/cellular therapy patients can be tricky, requiring a heavy understanding of the therapies and the challenges and fears that patients may have while considering enrolling. CSSi has experience recruiting patients in gene/cellular therapy studies and have created best-in-class strategies for patient enrollment. Interested in learning some of our tips and tricks? Look at some advice below.
Provide clear and accurate information about the trial to ensure well-rounded patient education: Patients need to have a clear understanding of what the trial involves, including the eligibility criteria, the potential benefits and risks, the time commitment, and any costs involved. Make sure to provide this information in a clear and concise manner that patients can easily understand. Try to avoid being overtly optimistic about the study – there are very real possible adverse effects and patients should weigh the risks against possible benefits before enrolling.
Build trust in the clinical trial process in order to provide clinical trial understanding and transparency: Patients may be hesitant to participate in a clinical trial due to concerns about the safety, tolerability, and efficacy of the therapy. To address these concerns, provide them with information about the rigorous regulatory process demanded by regulatory agencies (IRBs/ECs) that clinical trials must go through before being approved for use in humans. You can also provide them with testimonials from other patients who have participated in the trial if your study is not a first-in-human trial.
Work with patient advocacy groups to build relationships with the community: Patient advocacy groups can be a valuable resource for reaching out to patients who may be interested in participating in a gene/cellular therapy clinical trial. These groups can help spread the word about the trial, provide support and guidance to patients, and help address any concerns they may have. Conditions that are being addressed by gene/cellular therapy trials often have a very tight-knit community. Working alongside and with patient communities will improve trust and improve the likelihood of advocacy groups spreading awareness about the study.
Spread awareness using social media and other digital channels: Social media and other digital channels, such as search engines, can be an effective way to reach a large number of patients who may be interested in participating in a novel therapy clinical trial. This can be used by participating in patient forums and groups, advertising the clinical trial on social media and/or search engines, or starting a dialogue with patients using a study specific website.
Offer incentives and provide patient support: Depending on the trial, you may be able to offer patients incentives for participating, such as compensation for their time and travel expenses or even offering board and accommodations (for those multi-day visits at the site or hospital). Make sure to check with the regulatory authorities in each country you will enroll in to ensure that any incentives you offer comply with the regulations.
Ensure medical provider outreach and education: Medical providers can be a valuable resource for identifying patients who may be interested in participating in a gene or cellular therapy clinical trial. Usually armed with a large database of potential patients, this can be an easy way to reach out to qualified patients. Work with medical providers to provide them with information about the trial, patient/physician education and recruitment materials, and answer any questions they may have.
Utilizing the above strategies can influence patient awareness, recruitment, and retention! While these strategies are best used in tandem with each other, sites often are limited in time and resources. This can lead to many possible avenues of patient recruitment left unused, causing a delay in patient recruitment, and even leading to patient retention losses. Site coordinators often have several studies enrolling at one time which leads studies, especially complex studies in the gene and cellular therapy space, to be unattended to with low patient screening rates.
CSSi is able to step in and provide these patient recruitment measures quickly, effectively, and successfully. Our ability to cater to each site individually with their unique needs ensures that each site has their successes showcased and their challenges reduced. Site staff don’t need to scramble and half-heartedly (if at all) undergo these patient recruitment strategies when CSSi takes over these tasks. CSSi provides site support in all facets to make sure your site staff and patients are happy with the clinical trial recruitment process.
Contact us today to see how we can support your novel therapy study!
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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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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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.
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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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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.
