Patient Recruitment For Novel Therapies
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!