According to a 2017 national survey involving over 900 clinical research professionals, participant recruitment was identified as one of the top three struggles associated with starting up a new clinical trial. Another study found that patient recruitment took up almost 30% of development timelines, costing over US$1 billion. It’s no secret that this is one of the most common challenges facing dermatology clinical trials, sponsors, and contract research organizations (CROs), with recruitment difficulties typically causing delays of one to six months for most studies. With each day of delay, the pharmaceutical industry could potentially stand to lose anywhere from US$600,000 to US$8 million.

Sites and research institutions will often undertake studies without allocating the necessary resources, relying instead on their industry sponsors to already have a plan or anticipating their institutional name recognition to attract enough participants. The result is a low and slow patient accrual process, which wastes valuable time and money and could negatively impact the trial’s scientific validity. Therefore, with 11% of clinical research sites unable to recruit even one participant and 37% under-enrolling sites, sponsors must implement a robust patient recruitment plan well before study start-up and maintained throughout. To prevent low accrual proactively, TFS HealthScience CRO offers five effective patient recruitment strategies crucial for dermatology clinical trials! 

1. Increasing Patient Awareness of Dermatology Clinical Trials

A significant barrier facing patient recruitment across dermatology clinical trials is a general lack of awareness about these trials being a viable treatment option amongst potential participants. In one 2018 study, although 84.5% of individuals agreed to understand the importance of clinical trials, nearly 60% were unable to identify where to find studies of interest being conducted. Various platforms, including ClinicalTrials.gov and CenterWatch, have compiled detailed information on available dermatology clinical trials, including the objectives, status, required procedures, and patient eligibility rules. To increase participant awareness and education, clinicians can also direct patients to dermatology-focused and advocacy group websites, such as those associated with the American Association of Dermatology or the Coalition of Skin Diseases, to find study information specific to certain dermatologic conditions. In addition, social media campaigns and digital advertising can also help dermatology sponsors and CROs reach a broader audience for more effective patient recruitment. This approach is especially complementary to more traditional methods like physician referrals and helpful for raising awareness among younger patients. 

2. Understand Patient Needs and Preferences Before Study Start-Up

One of the first steps dermatology sponsors and CROs must take to ensure a smooth patient recruitment process is to understand patient needs and preferences before trial initiation. Patients themselves are key stakeholders in any clinical study, and creating opportunities for their voices to be heard helps ensure the right participants are recruited because the study endpoints will be relevant to their expectations. For example, there is ample evidence to support the significant psychosocial impact of skin diseases on patients, negatively impacting their well-being and quality of life. Therefore, the inconvenient and time-consuming nature of participating in dermatology clinical trials may be a key deterrent to be addressed in patient recruitment plans. The same 2018 survey mentioned earlier found that 49% of participants found that clinical trial participation disrupted their daily routine. Therefore, strategies to make the process less burdensome and disruptive are essential to have in place prior to study start-up.

For example, patients would likely be less reluctant to participate in studies with only occasional visits, as compared to those that involve several in-clinic or in-home visits. Even in the latter case, when close monitoring is unavoidable, sponsors have the option to provide convenient options, such as video conferencing, remote data collection, or flexible priority scheduling for appointments (e.g., evening and weekend hours). This strategy could also involve arranging transportation, covering childcare costs, and coordinating travel arrangements for participants who live far away. In general, the fewer additional inconveniences patients are burdened with, the more likely they will be to participate in dermatology clinical trials. 

3. Partner with Local Organizations to Assist with Patient Recruitment

Another key strategy to achieve successful patient recruitment in dermatology clinical trials is to harness the power of community engagement and tap into existing relationships between patients and trusted entities to increase the trial’s visibility and credibility. In a 2019 patient survey by the Center for Information and Study on Clinical Research Participation (CISCRP), 64% of patients reported preferring to learn about a clinical trial from their healthcare provider rather than a third party. Dermatology researchers and clinical sites can leverage this trust to connect with prospective participants through their primary caregivers by developing outreach materials specifically for dermatologists and general practitioners, as well as utilizing any existing relationships with local hospitals to promote the trial.

Additionally, collaborating with non-profit organizations and patient advocacy groups for skin diseases can further increase the visibility of dermatology clinical trials to raise awareness with the right potential participants. More importantly, drug trials that are endorsed by these organizations receive another layer of credibility because they are primarily concerned with serving the best interests of patients. Therefore, partnering with these types of groups can provide patients with a greater sense of security when debating whether to become involved, as well as enable sponsors to take advantage of their existing ties to the community to reach the target participant population more effectively.  

4. Harness Digital Platforms for More Effective Patient Recruitment

As new technological advancements emerge in the clinical trials industry, dermatology sponsors can boost traditional methods of patient recruitment by launching digital platform campaigns. In addition to social media marketing on apps like Facebook and Instagram, others have also been designed to optimize patient recruitment by building patient communities or through scanning electronic medical records. For example, Studies&Me is a Denmark-based company that provides a solution for physicians to evaluate potential patients using a store-and-forward telemedicine process involving a team of remote dermatologists and artificial intelligence (AI). If eligible, the platform is able to redirect interested patients to the closest possible site with the trial of interest within 48 hours. The Studies&Me platform was piloted in a study on patients with severe atopic dermatitis (NCT03131648). Although the screening failure rate remained similar in digitally referred subjects (22% vs. 22%), the average time in days spent per site per randomized subject was significantly shorter (21 vs. 65 days). This indicates that leveraging digital platforms can offer an effective alternative to the traditional approach for patient recruitment, even for dermatology clinical trials with complex eligibility criteria.  

5. Ensuring Access to Patients Early On with Careful Site Selection

The success of a clinical trial is critically dependent on whether sponsors have spent the necessary time on selecting the right clinical research sites. Without carefully evaluating whether a prospective site has access to the target patient population prior to trial initiation, the resulting patient pool volume may be insufficient to support the trial, particularly for rare diseases. Therefore, each clinical site must be thoroughly vetted prior to being brought onto a new study and this is where partnering with an experienced CRO can be a crucial step to ensuring successful patient recruitment. Dermatology CROs like TFS HealthScience readily offer a team of experienced clinical research professionals and often have greater access to high-quality investigative sites. Not only can CRO partners provide proactive planning and a systematic approach to site selection, but they can also guide sponsors in developing a robust patient recruitment and retention plan long before trial initiation to minimize delays. Visit the TFS Intellect Hub to discover how our CRO’s patient recruitment expertise previously rescued two dermatology clinical trials indicated for plaque psoriasis and onychomycosis. 

Conclusion

In conclusion, patient recruitment is a critical aspect of dermatology clinical trials, with challenges often leading to significant delays and exorbitant costs for sponsors with each day of delay. However, there are several approaches to overcome and subvert these obstacles prior to study start-up, including increasing patient awareness, understanding patient needs, partnering with local organizations, harnessing digital platforms, and selecting the right sites. With these strategies, and with the assistance of experienced dermatology CROs, sponsors can significantly improve their patient recruitment outcomes in dermatology clinical trials, ultimately helping keep planned study timelines intact, as well as upholding the study’s scientific validity.  

About TFS HealthScience Dermatology CRO

TFS HealthScience is a global dermatology CRO that supports sponsor companies throughout their entire clinical development journey, from patient recruitment and study start-up to large-scale clinical testing and post-market safety monitoring. As a trusted CRO partner for promoting innovation and the creation of novel therapies, the TFS Dermatology, Immunology & Inflammatory Diseases (DIID) business unit has established a strong partnership with our customers, supported by solution-driven teams working for a healthier future. Visit our website to learn more about the resources and services TFS can offer for your next dermatology clinical trial, or connect with a TFS representative today!