DIVERSITY, EQUITY & INCLUSION
Assessing the association between DCT solutions use and participant diversity in clinical trials
ZACHARY SMITH AND KENNETH GETZ, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, TUFTS UNIVERSITY
Credit: WESTOCK PRODUCTIONS via Shutterstock. I
mproved access to clinical trials, particularly among underserved communities, features prominently
in the value proposition of remote and virtual solutions use in clinical trials. Yet, to date, this association has not been demonstrated empirically. To address this need, in 2023 The Tufts Center for the Study of Drug Development (Tufts CSDD) gathered evidence from a convenience sample of pharmaceutical company protocols to assess the association between DCT solutions use and clinical trial participant diversity. In an unrelated study evaluating protocol design practices, Tufts CSDD collected data on 950 individual protocols from 16 pharmaceutical companies and contract research organisations (CROs). As part of the data collection process, Tufts CSDD asked companies to indicate whether individual remote and virtual solutions were used to support clinical trial execution. The following
definitions were presented in the data collection instrument for participating companies to select:
• Virtual or televisit – A scheduled participant evaluation in which procedures are performed outside of the clinic (e.g. telephone/mobile telephone, video conference app, secured electronic mail, social media platforms).
• Home visits – A home healthcare professional visits the participant’s home to perform evaluations or procedures.
• Devices or wearables – The participant is provided with a wearable or other device (i.e., iPad or a tablet) to use at home for data collection and recording, or participants are asked to download an app to a personal device which will be used to complete surveys or collect other data.
• Local labs – The participant travels to a local lab or clinic (instead of the trial site) to have procedures or tests performed.
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