Shann Williams is the Project Director of the statistical and clinical coordinating center for the Clinical Trials in Transplantation (CTOT) program sponsored by the National Institute of Allergy and Infectious Disease (NIAID). In addition, Shann serves as Rho's project management operational service leader, an internal expert overseeing project management processes and training.
A recently released Food and Drug Administration (FDA) report encourages enrollment of more women and minorities in clinical trials. The report identifies three priorities in order to address this need: participation, data quality, and transparency. Clinical research organizations (CROs) can help guide sponsors in all of these areas in order to ensure that their drug and device applications not only meet all of the current requirements, but that they are at the forefront of the direction of the FDA and of biomedical research as a whole.
Overcoming Barriers to Participation:
Finding solutions to barriers that limit participation in clinical trials by demographic subpopulations, particularly those populations that are underserved and underrepresented, is key to diversifying enrollment.
There are several ways sponsors and sites can overcome these barriers. Using available census data, mapping technologies, and peer-reviewed publications to understand the demographic variability of the disease population by region, site-specific enrollment goals and strategies can be created to ensure that percentages of subjects targeted and enrolled accurately reflect the available subpopulation at that site. Similarly, selecting new sites whose community make-up will help achieve enrollment goals can help if other sites encounter limitations.
Addressing the needs of non-native English speakers in the United States is immensely important to encouraging diversity. Sponsors can develop appropriate recruitment materials using the subpopulation’s native language and ensure these materials are accessible to the population of interest. Translation services and on-site translators also aid in ensuring informed consent forms are easily understood and thoroughly explained. Choosing translators with the same demographic background as subjects under study helps dispel mistrust and miscommunication. It is also important to administer informed consent forms in a format that is acceptable in that subpopulation. For example, providing adequate time and resources for all applicable family members to review information and offer guidance to the participant about whether or not they should consent may increase enrollment and help reduce drop out during the trial.
Identifying and addressing the motivations, cultural preferences and common barriers to participation for various sub-populations may increase recruitment and retention. Providing solutions to sites to address these barriers – including: tools and training for literacy problems, transportation or reimbursement for transportation, childcare options, flexible visit schedules to help with variable work schedules and options other than checks for participation reimbursements – all help to improve recruitment and retention and diversify enrollment.
Ensuring Data Quality:
As noted in the FDA report, data standards are integral to improving the completeness and quality of information based on demographic subgroups. Identify a CRO partner that has demonstrated leadership in the development and application of data standards. For example, it is important to have subject matter experts that have worked closely with the FDA and its reviewers on numerous clinical development programs, with a track record of successful submissions of several marketing applications with extensive demographic subgroup analyses.
Transparency in Reporting:
Data transparency must be a seamless next step in the clinical trials process, both for submitting reports to the FDA and for informing trial participants of the outcomes. Although the FDA report specifically focuses on data transparency in reporting to the FDA and other data sharing venues, providing study results directly to the trial subjects and their families helps to reinforce that these subjects have personally contributed to research in the disease area that impacts them personally. Results can be presented in the form of newsletters, handouts and tailored materials specific to the subpopulation of interest. This type of transparency further strengthens positive feelings regarding biomedical research as a whole to combat cultural and historical mistrust.