5 tips for expediting clinical trial recruitment in 2020
The invention of new drugs relies on the ability to test and validate the research. It hasn’t exactly been smooth sailing in recent years. In fact, it’s been notoriously difficult for organizations to conduct clinical trial recruitment successfully.
Often, specific clinical trials hav been abandoned or delayed as a result of a low number of subjects. Most trials are delayed by at least a month, while only 6% of the trials are completed on time.
Cancer-related clinical trial programs are particularly worrisome. Fewer than 5% of cancer patients participate in trials. According to the National Cancer Institute, if 10% participated in the studies, the tests would be completed within a year instead of the usual 3-5 years.
A study about attitudes and motivating factors behind reduced patient enrollment rates shows challenges in recruitment and retention of clinical trial subjects are a result of 3 main factors:
- Subject-related barriers
- Investigator-related challenges
- Protocol-related barriers
1. Subject-Related Barriers
These barriers relate to the participant’s view about the research. Subjects often feel like “guinea pigs” during the experiments. Additionally, participants may reject the research due to lack of support from family and friends.
2. Protocol Barriers
The design of the study can also hinder patient recruitment. Too many visits, invasive testing, or too many complicated procedures, for example, can discourage subjects from completing the trials. There is also the issue of some protocols following strict eligibility criteria that excludes the majority of subjects.
Clinical trials that take a long time may also affect a participant’s willingness to enroll in the study. For example, studies that last 5-10 years may experience little or no enrollment as few people are willing to commit to that time.
3. Investigator Barriers
These challenges relate to the researchers’ perception about the trial, their ability to communicate, and faith in the research. Investigators are not always able to explain the proposed study in a way that encourages subjects to participate. Time constraints and schedule conflicts deter investigators from dedicating time toward recruiting potential candidates.
- High cost of conducting clinical trials
- Long regulatory approvals
- Other barriers include:
- Poor patient recruitment strategies in clinical trials
5 Ways to Improve the Recruitment Process
1. Improve Patient Screening Methods
When a patient is identified, the research organization should have an effective screening process that is minimally invasive and/or requires little travel. Technologies such as remote sampling have made such processes possible.
Identified candidates can submit samples from wherever they are and at any time without visiting the research facility. Little training is required for sample collection. This eliminates the need for professionals traveling to perform the screening process.
2. Develop a Patient-Centered Recruitment Process
Stakeholders are increasingly shifting efforts to more patient-centered approaches when planning and executing recruitment strategies. The need is to plan recruitment strategies based on individual patients, not the disease. Specific patient recruitment strategies in clinical trial design process involve researchers partnering with patients in a bid to play a more active role in:
- Collecting feedback from patients about the study design
- Engaging patients, their peers, and community as volunteers in the trials
- Providing feedback about clinical results
- Setting research agendas
Such efforts foster patients’ sense of ownership as drug development companies shift focus to developing personalized and patient-centric medicine.
3. Use Interactive Aids to Encourage Enrollment
Lack of appropriate information is another obstacle preventing people from enrolling in clinical trials. A review conducted in 2013 to determine the effect of modifying trial information and how it is delivered influenced the enrollment rate:
A comparison of written, audiovisual and video materials showed subjects were more willing to participate in the trials if the information was presented using videos. Also, an interactive computer presentation improved recruitment compared to the audiotaped display.
4. Leverage Mobile Platforms and Social Media
How patients learn about clinical trials has changed over the years. Previously, patients learned about trials via mail, media, and their HCPs. In the early 2000s, there was a significant shift in how the organizations solicited potential candidates.
The CROs no longer needed to “snail-mail” patients because other communication channels (email, etc.) had been invented. Today communication is much more direct, thanks to smartphones and the use of social media platforms. One study revealed social media platforms like Facebook have potential when it comes to recruiting individuals for clinical trials.
5. Implement Systems to Monitor and Follow-Up With Patients
When the patients have enrolled in the study, the research organization should implement ways to follow-up with patients to improve the retention rate. Again, remote sampling plays a critical role. The researchers can remotely monitor patients’ responses to new drugs using microsampling devices like the Mitra.