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Overcome Today’s Clinical Trial Enrollment Challenges

Overcome Today’s Clinical Trial Enrollment Challenges blog image,

The efficient and timely enrollment of study participants is key to the success of clinical trials. However, the process of clinical trial recruitment has consistently been associated with challenges. For example, up to 85% of clinical trials face difficulties to reach the planned number of recruited subjects within the predesigned time window. Moreover, recruiting into clinical research has become increasingly challenging, with poor recruitment being one of the leading causes of premature termination of clinical trials  

Not being able to reach the recruitment goals of a clinical trial can have a serious negative impact on an early phase drug development program. Thus, if the planned sample size is not achieved due to recruitment challenges, the study may lack the statistical power to draw valid conclusions from the data. Moreover, recruitment challenges may cause delays in study completion and may be associated with increased costs. Therefore, the identification of clinical trial enrollment challenges and the development of strategies to overcome them are key for the success of clinical drug development programs.

Barriers to Study Enrollment

A variety of factors may negatively affect the recruitment of study participants, making recruiting into research even more difficult, including;

  1. Lack of awareness of clinical trials – Many potential study participants may not be aware of clinical trial opportunities that they would be eligible for. For example, in a Canadian survey examining the perspective of the Canadian public on clinical trials, 43% of the surveyed individuals felt either not very informed or not at all informed about clinical trials.
  2. Logistic challenges – Geographic, financial, and time constraints may also limit the enrollment of potential study participants. Thus, in certain geographic locations, such as rural areas, there may only be a very limited number of clinical trial opportunities. Moreover, the cost of transportation, time off work, and childcare may be prohibitive for some individuals. Finally, it may be difficult for some prospective study participants to set aside the time required to complete study visits.
  3. Stringent eligibility criteria – Setting too stringent inclusion and exclusion criteria limits the number of individuals that may be eligible for a clinical trial. In addition, the exclusion of subsets of potential study participants due to too stringent eligibility criteria may decrease the representativeness of normal healthy volunteers (NHVs) enrolled in clinical trials with respect to  the general population.
  4. Safety and efficacy concerns – Some potential study participants may have concerns regarding adverse effects of a study drug, discouraging them from enrollment in the clinical trial.  Moreover, in clinical trials involving patients, participants may also have doubts regarding the efficacy of a study drug.

Strategies to Enhance the Enrollment of Study Participants

There are certain strategies you could employ to enhance the enrollment of study participants:

  • A recruitment plan tailored to the needs of the study – One of the most important steps in improving clinical trial enrollment is to identify potential barriers to recruitment for each study and to design a recruitment plan that is aligned with the needs of the drug development program.
  • Extending the outreach to potential study participants – Actively reaching out to the community can increase awareness of clinical trials among potential study participants. Information about upcoming clinical trials can be publicized via press releases, public lectures, brochures, newsletters, media advertisements, and community sessions. In addition, the relevant information should be presented to prospective study participants in their language and at the appropriate literacy level.
  • Addressing logistic challenges – Identifying and mitigating potential logistic challenges can improve clinical trial enrollment. The introduction of compensation and incentives for clinical trial participation can help alleviate the financial burden of study participants. Finally, employing a flexible study schedule and reducing the trial burden can help overcome time constraints.
  • Building strong rapport with study participants – Fostering an atmosphere of mutual respect and trust is critical for the successful recruitment and retention of study participants. In this regard, it is important to work with an experienced team of recruitment specialists who can efficiently address participants’ concerns. Maintaining regular contact via phone calls or emails can further foster the relationship. In addition, creating a database of potential study participants can help establish strong rapport and a long-lasting relationship with them. Finally, the involvement of dedicated site champions can facilitate clinical trial recruitment.
  • Employing digital marketing tactics and data-driven recruitment – The use of innovative technologies has been shown to enhance study recruitment. Employing digital marketing tactics, study sponsors can reach many potential study participants in a targeted manner. In addition, real-world data can help gain insight into the preferences and behaviors of prospective study participants and can guide recruitment to improve enrollment outcomes.

Engaging Underrepresented and Special Populations

In clinical trials, special populations encompass groups of individuals with unique characteristics, including minors; older adults; certain racial, ethnic, and cultural groups; and people inhabiting rural areas. Special populations often remain underrepresented in clinical trials, despite ongoing efforts to improve recruiting into clinical research for these groups. The inclusion of individuals from special populations in clinical trials is important, because there may be age-specific and genetic variations in drug metabolism that should be accounted for in clinical research. Moreover, cultural factors and geographic isolation may contribute to the behaviors and health outcomes of individuals and should be considered in clinical trials.

Several of the strategies that have shown particular significance for the recruitment of underrepresented and special populations include:

  • Designing clinical trials that are relevant to the community – Addressing a clinical research topic that is relevant to the community can provoke enthusiasm among potential study participants and improve recruitment rates.
  • Offering meaningful incentives – Introducing non-conditional incentives, compensating study participants  fairly for their time and efforts and facilitating their access to the clinical trial site can also aid clinical trial enrollment.
  • Building trusting relationships – Gaining the trust of study participants from underrepresented and special populations requires time and effort. However, establishing trusting relationships is key to successful clinical trial enrollment.
  • Employing a culturally sensitive approach – Study participants should be approached in a manner that is aligned with their values and beliefs. In addition, study materials and protocols should be tailored to the cultural context of the community. Engaging a consultant from the community, in which recruitment will be performed, can help study sponsors better understand the community culture.

Recruitment Strategies for Different Types of Studies

Enrollment in different types and phases of clinical trials is associated with distinct challenges. For example, recruitment for human abuse potential (HAP) studies may be impeded by the hesitation of potential study participants to admit stigmatized behaviors and their concerns regarding data confidentiality. Therefore, recruitment strategies should be tailored to the type and phase of a clinical trial.

Regulatory and Ethical Considerations

To ensure that study participants are treated fairly, and high-quality data are obtained, clinical trials should comply with all relevant regulatory requirements. In addition, information materials and consent forms should include details about all aspects of the planned trial and its associated risks. This is particularly important for clinical trials recruiting individuals from vulnerable populations. Moreover, the choice of appropriate compensation for clinical trial participants should be discussed carefully by the study team.

BioPharma Services Expertise in Clinical Trial Enrollment

BioPharma Services is a full-service, early-phase, award-winning contract research organization (CRO) with extensive and multifaceted expertise in the process of clinical trial enrollment. We can ensure timely and efficient recruitment for our clients’ clinical drug development programs by offering:

  • Well-established recruitment procedures, developed and optimized over decades of clinical trial operations and with the completion of over 2,000 clinical trials.
  • A large database of potential study participants, including over 24,000 individuals. Our database encompasses both normal healthy volunteers (NHVs) and individuals from special populations.
  • An expert team of recruitment specialists, who have gathered experience in study participant enrollment across various clinical trial types and disease areas.
  • Ability to build strong rapport and supportive relationships with study participants, as evidenced by our excellent track record in clinical trial enrollment and positive feedback by study participants.
  • Experience with the recruitment of individuals from special populations – BioPharma Services has extensive expertise in the recruitment of individuals with various backgrounds and demographic and clinical characteristics.

If you would like to work with an expert medical and scientific team that can assist you with all aspects of your clinical drug development program, including clinical trial enrollment, schedule a discovery call with BioPharma Services today.

BioPharma Services, Inc., a HEALWELL AI 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, Human Abuse Liability(HAL) and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma Services conducts clinical research operations from its Canadian facility, with access to healthy volunteers and special populations.

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