5 tips for expediting clinical trial recruitment
by Neoteryx Microsampling on Mar 25, 2020 7:00:00 AMNew drug development 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 have been delayed or abandoned due to a low number of subjects. Most trials are delayed by at least a month. It is estimated that only 6% of clinical trials are completed on time.
Recruitment and retention of volunteers for 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% of oncology patients participated in studies, the trials 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:
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-related Challenges –These challenges relate to the researchers’ perception about the trial, their ability to communicate, and their 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 can also deter investigators from dedicating the necessary time toward recruiting potential candidates. In short, they may have poor patient recruitment strategies.
Additional factors or barriers to recruiting for clinical trials may include the high costs or budgetary constraints.
5 Ways to Improve Clinical Trial Recruitment
1. Improve Patient Screening Methods
When a patient is identified, the research organization should have an effective screening process that isn't disruptive and/or requires little travel.
If blood testing is part of the screening process, it is important to make this as convenient and comfortable as possible. Technologies such as remote sampling have made mobile or portable approaches to such processes possible.
With remote microsampling, clinical trial candidates can submit samples from wherever they are and at any time without visiting the research facility or trial site. Minimal training is required for finger-stick sample collection using remote tools such as the Mitra® device.
These devices can be shipped to study candidates or participants at home in kits, which eliminates the need for professionals traveling in mobile units to perform the screening process. Related candidate screening activities can be conducted online, using secure digital portals dedicated to the study.
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 patients needs, not the disease. Specific patient recruitment strategies in clinical trial design process involve researchers partnering with patients in a bid to generate active involvement in:
- Collecting feedback from patients about the study design
- Determining how to effectively engage patients, peers, and communities as volunteers in the trials
- Providing feedback about clinical processes
- Setting research agendas
Such efforts foster patients’ sense of ownership in the drug development process as pharmaceutical 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, interactive computer presentations or web pages as resources that offered both videos and illustrated instructions improved recruitment compared to simply an audiotaped display.
4. Leverage Mobile Platforms and Social Media
How patients or others learn about clinical trials has changed over the years. Previously, patients learned about trials via mail, the media, and their own healthcare providers. In the early 2000s, there was a significant shift in how the organizations solicited potential candidates.
The contract research organizations (CROs) working with pharmaceutical companies no longer needed to rely on the healthcare provider's word of mouth to patients or on “snail-mail” promotions to their mailing lists. Digital communication channels (email, etc.) had become more sophisticated and were being utilized for recruitment.
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 great potential when it comes to recruiting individuals for clinical trials.
5. Implement Systems to Monitor and Follow-Up with Patients
After patients have enrolled in a study, the research organization, CRO or pharmaceutical trial sponsor should implement ways to follow-up with the patient recruits to ensure they stay engaged, which can help improve the study retention rate.
Again, remote blood microsampling can play a critical role in study retention. The researchers can remotely monitor patients’ responses to new drugs using microsampling devices that enable them to self-collect samples at home and mail them directly to the lab for analysis.
Learn more about remote microsampling to improve clinical trial recruitment and retention by visiting our resource page, Microsampling for Decentralized Clinical Trials:
Image credits: Trajan, Neoteryx, iStock
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