4 Tips for Overcoming Common Clinical Trial Recruitment Challenges

4 Tips for Overcoming Common Clinical Trial Recruitment Challenges

Alzheimer’s and other neurological disorders, such as dementia, affect over 747,000 people, or 7.1% of Canadians. By 2030, over 900,000 Canadians are expected to suffer from this disease.

Clinical research studies show that approximately US$10.4 billion is spent on Alzheimer’s and dementia every year by the Canadian economy and healthcare system. The cost of bringing a new dementia-targeting drug to market is approximately US$360 million. Add the number of people living with dementia (44 million worldwide — more than the total population of Canada), which makes the disease a global health crisis.

So, why are clinical trials still not delivering results? Before a new drug can apply for market approval, it must successfully pass three phases of clinical trials. Due to their proneness to delays and failures, these trials represent a significant financial investment for pharma companies. A trial’s failure correlates directly with patient recruitment and retention within the specified timeframe. A staggering 85% to 90% of studies are facing this issue.

Clinical trials fail to enroll approximately 80% of participants on time, while Phase III trials last longer than expected due to recruitment challenges. One-third of trials fail to enroll their target number by the deadline, and only 7% meet their enrollment on time. This way, a pharmaceutical company can lose up to US$8 million daily due to market launch delays for a new drug.

Physicians manually use their patient lists to identify eligible participants. Aside from being a lengthy, cost-intensive, and time-consuming process, there is no guarantee that it is foolproof. Unfortunately, the current approach to clinical trial recruitment is outdated, causing many suitable candidates to be overlooked this way.

Alzheimer’s disease continues to exponentially impact patients, their caregivers, and the scientific and medical communities unless corrective measures are made. However, finding enough eligible participants is challenging for several reasons due to the unique circumstances of this disease.

In particular, this refers to research aimed at preventing the disease since symptoms are usually present before the disease is fully developed. Often, studies require specific strategies, such as identifying biomarkers for the disease, which can increase failure rates and costs. Researchers usually screen tens of thousands of cognitively healthy individuals to enroll a few thousand older adults in prevention trials.

Truthfully, these hurdles are not unique to Alzheimer’s, and every study faces them. However, they can be beneficial because they can provide material for learning how to address recruitment targets essential for progressing important research to researchers across different disease areas.

It is possible to solve this problem by using recruitment registries that identify available studies and match participants. One such registry is Gene Match — an online registry created by the Alzheimer’s Prevention Initiative. This trial-independent research enrollment program enrolls cognitively healthy adults into Alzheimer’s prevention studies based partly on their APOE genotype, a genetic risk factor for Alzheimer’s.

People who can sign up for the registry must be between 50 and 90 years old and must not have any cognitive impairment, dementia, or Alzheimer’s diagnosis.

The registry was launched in 2015 and, since then, has managed to recruit more than 75,000 participants successfully. Among them, 3% of patients had two APOE4 alleles, and 30% had one APOE4 allele. It is vital to detect the e4 type of the APOE gene since it is connected to late-onset Alzheimer’s.

During the last seven years of operation, the people behind Gene Match have gathered a lot of helpful information about what works and gives results in overcoming recruitment challenges and found the four most important ones.

Participants Are Well-Informed Before Submitting Genetic Information

Many people mistakenly believe that informed consent refers to getting the consent form signed by a research participant. According to the FDA, obtaining informed consent, oral or written, only constitutes one part of the process.

Participants must have sufficient opportunities to consider participation for the process to be effective. To achieve this, participants should have enough time to view the information, understand the entire process, and have the opportunity to ask and receive answers to their questions. Aside from getting their voluntary agreement to participate, they should also continue to obtain information as the clinical investigation progresses.

Since patients fill in the online form to register at Gene Match and no healthcare provider is present, it is crucial to follow the protocol. Gene Match changed and evolved with time, following the patients’ feedback. Right after its launch in 2015, potential participants had to open their accounts and provide personal information before completing the education module.

The module would provide information about the APOE gene, Alzheimer’s disease, and the Gene March program. Once they finished the module, the participants had to answer five questions which provided enough feedback to the organization to consider modifying certain parts of the process. Therefore, they included a mandatory brief that would educate potential participants about the program before opening an account. This slight alteration had a significant positive impact on enrollment and drop-off rates.

Privacy Protection and Preexisting Condition Awareness

Since clinical trials rely heavily on Protected Health Information (PHI) data, protecting it has become a top priority. Any information that could reveal the person’s identity must be protected from breach, loss, or access by unauthorized parties. Concerns about the privacy retention of sensitive genetic information seem to be one of the leading obstacles to patient recruitment and retention.

Gene Match has addressed these concerns by obtaining the NIH’s Certificate of Confidentiality. Furthermore, they are transparent that the prominent Banner Alzheimer’s Institute supports their work and stands behind them. To further reinforce the participants’ confidentiality, Gene March included information about the Genetic Information Nondiscrimination Act in their FAQ section.

Partnerships With Local Programs

Having only an online platform for patient recruitment is good, but it also has its downsides. One of them is an older population lacking digital literacy. The other occurs when an individual wants to participate but has to wait two weeks for the cheek swab kits to arrive. This is a waste of time and frustrating for researchers and physicians who cannot enroll the potential candidate immediately.

Following this feedback, GeneMatch launched a healthcare partner site program that allows investigators from other institutions to become sub-investigators in the GeneMatch study, allowing quick enrollment and distribution of cheek swab kits. In addition, community members can learn about this program at community events and decide on registration after speaking with their healthcare provider. It is helpful for patients to have support from local healthcare providers as this helps them reduce anxiety, stress, and comfort and build relationships with them.

Online Marketing Tactics and Social Media to Reach Your Target Audience

As the use of social media networks has grown and expanded over the past ten years, pharmaceutical companies and CROs now have a powerful tool for engaging with patients and recruiting them for clinical trials. Interestingly, the older population, especially seniors over 65, usually uses Facebook. Therefore, 93% of marketers use social media channels such as Facebook, Instagram, and other online marketing tactics to reach their target audiences.

Social media platforms and internet search engines offer many advantages over traditional recruitment methods. They are budget-friendly and can reach diverse and broad audiences, especially hard-to-reach groups that cannot easily be accessible through other methods.

GeneMatch consistently uses various social media platforms and digital marketing techniques to reach target audiences. Even 60% of their participants joined GeneMatch, thanks to online marketing campaigns and initiatives.

The social media and online marketing initiatives helped Gene March increase the number of male participants from 21% to 44%. They also hope to achieve the same result with ethnic and racial minorities.

Final Thoughts

Although relatively young, Gene Match has accomplished much since its launch date. Thousands of participants completed home cheek swab kits as part of the program, recruiting tens of thousands of participants online. Their goal is to become a reliable resource regarding reducing screen failure rates, efficiently refer participants to Alzheimer’s prevention studies, and become a role model for other clinical research.

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