Improving Access to Patient-Focused, Decentralized Clinical Trials Requires Streamlined Regulatory Requirements: An ASCO Research Statement.
Ramya ThotaPatricia A HurleyTherica M MillerSuanna Steeby BruinoogeCraig LipsetRobert Donald HarveyLora J BlackAmanda DinsdaleJanette K MerrillTeri PollastroSheila A PrindivilleMujahid A RizviShimere SherwoodGrzegorz S NowakowskiPublished in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2024)
Strategies to bring clinical trials closer to patients gained momentum during the COVID-19 pandemic, enabling more participants to receive treatment and/or testing in their local communities. Incorporation of decentralized trial elements presents both opportunities and challenges, spanning regulatory, technical, and operational aspects. This ASCO research statement includes timely consensus-driven recommendations and a call for engagement of all research stakeholders. ASCO held multistakeholder meetings with leaders in oncology research and concluded that research-related regulatory and administrative requirements and burdens present critical barriers to decentralizing trials. One example is sponsor and contract research organization (CRO) use of US Food and Drug Administration (FDA)'s Statement of Investigator (Form 1572), which was found to exceed FDA's stated intent and used in conservative ways disproportionate to potential risks to participants and scientific integrity. As a result, research sites experience an avalanche of downstream administrative and regulatory activities that consume considerable resources. This statement recommends four key solutions to address such barriers and recalibrate regulatory and administrative expectations for decentralizing trials: (1) FDA should engage the research community in a public-private partnership to modernize standards and enable local access to trials; (2) sponsors and CROs should develop standards and protocols that accommodate flexible approaches, enable local participation, provide clarity around roles and requirements, and promote consistency; (3) research centers, networks, and sites should update policies and procedures to implement decentralized trial elements; and (4) research community should develop a streamlined, uniform mechanism to simplify regulatory data collection and documentation and use it consistently across trials. We can and must prioritize a concerted commitment to simplify and streamline regulatory requirements and practices to broaden access to and participation in cancer clinical trials.
Keyphrases
- clinical trial
- transcription factor
- healthcare
- phase ii
- mental health
- phase iii
- physical activity
- drug administration
- electronic health record
- risk assessment
- end stage renal disease
- papillary thyroid
- randomized controlled trial
- clinical practice
- social media
- emergency department
- case report
- young adults
- big data
- climate change
- artificial intelligence
- lymph node metastasis
- smoking cessation