This Initiative has achieved its goal of developing better practice materials for Site and Sponsors to improve engagement and recruitment of minority patient populations. To learn more about this Initiative’s mission and accomplishments please continuing reading below.
Minority patients have often been underrepresented in clinical trials. Despite various safety, clinical, regulatory, commercial and ethical needs to increase the representativeness of trials, study teams are often unaware of the need for diversity and the resources available to improve the recruitment and retention rates of racially and ethnically diverse populations.
A broader recognition of the benefits and techniques of improving diversity in clinical trials is needed. TransCelerate’s Clinical Trial Diversification Initiative enhances the racial and ethnic diversity of clinical trial populations by helping sponsors achieve trials that are representative of the indicated population.
The Clinical Trial Diversification Initiative, through practices and tools, delivers a broader understanding of the need for representative trials, and how best to help sponsor companies meet the trial needs of patients, clinicians and regulators.
The Initiative has developed sponsor and clinical trial site guidance on better practices and processes for minority recruitment. The guidance focuses on six key areas.
Pediatric Trial Efficiencies
The Pediatric Efficiencies Initiative thoroughly assessed potential solutions that would lead to faster access to new drugs for pediatric patients. Rather than continue as a standalone initiative, we will transition the focal points of pediatric populations across the broader TransCelerate portfolio, where appropriate.
The TransCelerate eLabels initiative will help the industry progress on the journey to digitally supported, patient-centric clinical supply chains.
Placebo and Standard of Care Data Sharing
The Placebo and Standard of Care (PSoC) Initiative was established to enable the sharing of data to maximize the value of clinical data collected historically in the placebo and standard of care control arms of clinical trials.