On November 28, Crowell Health Solutions published 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 that can be leveraged to support DCT adoption.
The DCT 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. Specifically, the Consolidated Appropriations Act, 2023 directed the HHS Secretary, in collaboration with the U.S. Food and Drug Administration (FDA), Office of the National Coordinator for Health Information Technology (ONC), and the Centers for Medicare & Medicaid Services (CMS), to evaluate agency practices across HHS and deliver a report to Congress with its findings and recommendations to accelerate DCTs and increase trial diversity by mid-2024.
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.
The DCT white paper includes the following policy recommendations:
- CMS Incentives: 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.
- CMS Innovation Center Demonstration: The CMS Innovation Center should create a new payment and service delivery model that incentivizes providers to use DCT to improve health outcomes and increase Medicare beneficiaries’ enrollment in clinical trials.
- Standards: 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.
- Trusted Exchange Framework and Common Agreement (TEFCA): ONC should include “Research” as an exchange purpose under Trusted Exchange Framework and Common Agreement to advance clinical research and promote clinical trial participation.
- FDA Guidance: 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.
- FDA Demonstration Project: FDA should conduct a demonstration project on the use of digital health technologies (DHTs) in DCTs. The project should focus on a number of issues, namely benefits of DHTs, current regulatory and operational barriers of using DHTs, and inter-agency coordination to support DHTs use in DCTs.
- 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.
- National Institutes of Health (NIH) Grants: NIH could promote widespread DCT adoption in the health care community by providing grant funding and/or other incentives to enable use of DHTs and advanced decentralized trials, in general. To support these efforts, Congress should enact legislation or submit appropriations report language directing NIH to establish a program to advance adoption of DCTs by the health care community.
For more information on the DCT white paper or current regulations governing DCTs, please contact the professionals listed below, or your regular Crowell Health Solutions contact.