Recruitment of Study Participants Is Vital to Phase 1 & 2 Clinical Trial Success
The recruitment and retention of study participants are essential for the success of clinical trials, including Phase 1 clinical trials and 2 studies. Unfortunately, many clinical trials are unable to recruit a sufficient number of study participants to ensure Clinical Trial end points are met, requiring an extension of the study duration or additional groups and/or funding to complete the study. In addition, the retention of study volunteers throughout a trial is also challenging.
For these reasons and more, difficulty with subject recruitment and retention is one of the main reasons clinical studies and drug development can fail.
Challenges with recruitment and retention of study participants
Numerous difficulties can arise regarding subject recruitment related to the study participants themselves, the research project, and contextual or environmental factors. For example, potentially eligible participants may not be aware of the possibility of joining a clinical trial due to a lack of information. Moreover, study protocols may not reflect the preferences of eligible individuals for specific treatments or may provoke concerns regarding potential side effects of the investigational drug. Further, individuals may perceive the distance to a study site or the study duration as prohibiting them from participation. However, sponsor-related challenges also may affect recruitment. Such issues may relate to too stringent eligibility criteria, delays in funding or documentation compilation, and logistic difficulties.
In addition to recruitment, clinical trials face significant challenges related to participant retention, leading to the delay or failure of a proportion of clinical trials. Some of the reasons that subjects have named for early withdrawal from a clinical trial include long study duration, perceived lack of effect of the study drug, relocation, lack of time to fulfill the study requirements, and fear or history of adverse effects.
Specific to early-phase clinical studies recruitment challenges
Early-stage clinical trials pose unique challenges concerning study recruitment. Since the therapeutic benefit is generally low in early-phase clinical trials, understanding participants’ motivations and expectations is especially important in enrollment of volunteer participants. Moreover, Phase 1 clinical trials are complex and require extensive activities, placing high demands on participants’ time. In addition, the outreach to potential participants in early-phase clinical trials may be especially challenging.
Strategies to optimize study recruitment
The importance of attracting subjects to clinical trials cannot be understated and has significant implications on the integrity of a study. However, in light of the severe difficulties with participant recruitment and retainment for clinical trials, optimized recruitment and retention strategies should be developed. The timely preparation of a recruitment and retention plan that considers the specifics of the study protocol and study population is key to the success of a human clinical trial. Involving potential participants in a learning process and informing them about the health consequences of a health condition can also increase their motivation to participate in a study. The use of media and online resources, including press releases and dedicated websites, may also contribute to improved patient recruitment. Finally, establishing databases with potential study participants may streamline the recruitment process.
The potential of participant databases to facilitate clinical study recruitment
The creation of databases of individuals who are ready to participate in research studies presents one potential solution. Recruitment from potential participant panels has many advantages, such as:
- Availability of collected background data: Background data for the participants in a panel have already been collected.
- Commitment of participants to involvement in clinical studies: The participants in a panel have already indicated that they are willing to participate in a clinical trial.
- Possibilities for multiple assessments: Due to the commitment of panel participants involved in clinical studies, there are opportunities for numerous evaluations.
- An efficient and streamlined recruitment process: The recruitment of participants from a study panel facilitates and streamlines the recruitment process.
The need for diversity in clinical trials and study panels
Many medical conditions can differently affect certain groups or segments of the population. Moreover, some communities will be more likely to use an investigational drug after it has been approved or be more vulnerable to its potential adverse effects. Thus, the diversity of clinical trial participants needs to be considered and often increased to reflect more closely the population that will be treated with a drug in the clinical practice after its potential approval.
To highlight the significance of this issue, in 2020, the FDA issued guidance on enhancing the diversity of clinical trial populations. However, many clinical trials do not achieve sufficient enrollment of underrepresented groups.
For example, sponsors recruit from different pools of study subjects that may over- or under-represent certain population segments. Moreover, some population groups may have less awareness of recruiting studies or may perceive more barriers in terms of time and distance to the study sites. Recruitment from research panels with study volunteers that also include special populations may facilitate the diversification of participant recruitment.
BioPharma’s comprehensive recruitment strategy and participant database
BioPharma Services has established a database with more than 18,000 well-informed and compliant potential study participants. Our study panel encompasses male and female healthy subjects and special populations, including recreational drug users, post-menopausal or surgically sterile females, and different ethnic groups. The company has two clinical study sites – in Toronto, Canada, and St. Louis, Missouri – with state-of-the-art infrastructure and expert teams for early-phase drug development programs.
BioPharma Services’ recruitment process is comprehensive and efficient. It begins with registration/pre-screening. Potential participants who meet the research eligibility criteria then visit one of our study sites for thorough screening and a consent session. If the potential participants are assigned to a study, they complete the study visits and are compensated for their involvement.
Our recruitment strategy is based on strong rapport and mutual trust with study participants, enabling us to generate reliable data with a high level of integrity. Moreover, we adhere strictly to the recommendations of the FDA and Health Canada for the recruitment of study subjects. BioPharma’s reliable recruitment strategies and longstanding relationships with healthy and specific populations facilitate and streamline the recruitment process, translating into the timely and efficient conduct of human clinical trials.
Contact us to learn more about participating in a clinical trial.
Why Choose BioPharma Services?
BioPharma Services, Inc., a Think Research Corporation and clinical trial services company, is a full-service Contract Clinical Research Organization (CRO) based in Toronto, Canada, specializing in Phase 1 clinical trials 1/2a and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with access to healthy volunteers and special populations.