In recent years, rapid developments in digital health technologies has made it easier to collect, transfer, and store electronic data and has expanded the methods in which clinical trial sponsors may conduct research investigations, including through decentralized and hybrid clinical trials.
Crowell Health Solutions published today a white paper outlining several policy recommendations to advance widespread adoption of decentralized clinical trials (DCTs). The white paper titled, “Advancing Adoption of Decentralized Clinical Trials: Rationale, Current State, and Policy Recommendations” examines the current environment on decentralized and hybrid clinical trials, including a discussion on benefits and challenges that DCTs may pose; existing legislation and regulation; and background on programs and policies, not specific to DCTs or clinical trials, that can be leveraged to support DCT adoption.
“We developed this white paper to ensure that federal policies enable widespread adoption of DCTs to drive improvements in clinical and biomedical research that result in advances in treatment for patients, ”said Jodi G. Daniel, partner in Crowell & Moring’s Health Care Group and managing director of Crowell Health Solutions. “Compared to traditional on-site clinical trials, conducting DCTs offers numerous benefits, including reducing time and expenses for patients and clinicians, increasing and improving recruitment of trials participants, and improving health equity by expanding trial participation opportunities for different population groups.”
The white paper highlights specific issues and recommends a number of policy recommendations for inclusion in the Department of Health and Human Services’ (HHS) upcoming report to Congress and for HHS’ further action. These recommendations were developed through rigorous discussions where health care industry stakeholders – patient and cancer advocacy groups, health care associations, pharmaceutical companies, and health technology companies – evaluated policy and clinical gaps in the current regulatory framework governing DCTs.
Top policy recommendations in the white paper include:
- CMS Incentives: The Centers for Medicare & Medicaid Services (CMS) should incorporate support for DCT in the Merit-based Incentive Payment System (MIPS) Promoting Interoperability Performance Category, such as by providing bonus points for clinicians that identify and enroll patients in DCTs and report data collected during DCTs.
- Standards: The Office of the National Coordinator for Health Information Technology (ONC) should further support interoperability for clinical research exchange purposes by participating in standards development efforts that target clinical trial data and exchange needs and adopting standards for developers of health IT under the ONC Health IT Certification Program. To enable these efforts, Congress should ensure ONC has sufficient funding to support standards efforts that advance clinical trials and DCTs, in particular.
- FDA Guidance: The U.S. Food and Drug Administration (FDA) should include in final guidance provisions to enable the collection of clinical data and to further enable clinicians to support patients when participating in DCTs. Specifically, FDA should encourage trial sponsors to use ONC adopted data standards, to the greatest extent possible, including United States Core Data for Interoperability (USCDI), for clinical trial recruitment. FDA should retain flexibility for trial sponsors in situations where existing USCDI data elements do not allow for the collection of needed data and work with ONC to develop standards that support DCT.
- Protecting Privacy and Security: The HHS Office for Civil Rights (OCR), ONC, FDA and the National Institute of Standards and Technology (NIST) should collaborate to provide guidance on privacy and security standards for DCTs. Specifically, agencies can outline privacy and security needs and explain how stakeholders can address such needs when conducting DCTs and hybrid clinical trials.
For additional information and to read the full white paper, visit Crowell Health Solutions.
About Crowell Health Solutions
Crowell Health Solutions is a strategic consulting firm focused on helping clients to transform health care and pursue and deliver innovative alternatives to the traditional approaches of providing and paying for health care, including through digital health, and value-based health care. The firm helps clients bring pioneering products and services to market, structure value-orientated collaborations and business arrangements, and advance policy priorities, including health equity, in the complex and rapidly evolving health care environment.
