Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective.
Amos J de JongTessa I van RijsselMira G P ZuidgeestGhislaine J M W van ThielScott AskinJaime Fons-MartínezTim De SmedtAnthonius de BoerYared Santa-Ana-TellezHelga Gardarsdottirnull nullPublished in: Clinical pharmacology and therapeutics (2022)
Decentralized clinical trials (DCTs) have the potential to improve accessibility, diversity, and retention in clinical trials by moving trial activities to participants' homes and local surroundings. In this study, we conducted semi-structured interviews with 20 European regulators to identify regulatory challenges and opportunities for the implementation of DCTs in the European Union. The key opportunities for DCTs that were recognized by regulators include a reduced participation burden, which could facilitate the participation of underserved patients. In addition, regulators indicated that data collected in DCTs are expected to be more representative of the real world. Key challenges recognized by regulators for DCTs include concerns regarding investigator oversight and participants' safety when physical examinations and face-to-face contact are limited. To facilitate future learning, hybrid clinical trials with both on-site and decentralized elements are proposed by the respondents.
Keyphrases
- clinical trial
- transcription factor
- phase ii
- phase iii
- physical activity
- study protocol
- open label
- end stage renal disease
- ejection fraction
- double blind
- primary care
- newly diagnosed
- mental health
- randomized controlled trial
- electronic health record
- cross sectional
- climate change
- risk assessment
- machine learning
- big data
- current status
- quality improvement
- human health
- patient reported