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.

Print:
Email this postTweet this postLike this postShare this post on LinkedIn
Photo of Jodi G. Daniel Jodi G. Daniel

Jodi Daniel is a partner in Crowell & Moring’s Health Care Group and a member of the group’s Steering Committee. She is also a director at C&M International (CMI), an international policy and regulatory affairs consulting firm affiliated with Crowell & Moring. She…

Jodi Daniel is a partner in Crowell & Moring’s Health Care Group and a member of the group’s Steering Committee. She is also a director at C&M International (CMI), an international policy and regulatory affairs consulting firm affiliated with Crowell & Moring. She leads the firm’s Digital Health Practice and provides strategic, legal, and policy advice to all types of health care and technology clients navigating the dynamic regulatory environment related to technology in the health care sector to help them achieve their business goals. Jodi is a contributor to the Uniform Law Commission Telehealth Committee, which drafts and proposes uniform state laws related to telehealth services, including the definition of telehealth, formation of the doctor-patient relationship via telehealth, creation of a registry for out-of-state physicians, insurance coverage and payment parity, and administrative barriers to entity formation.

Photo of Cara Tenenbaum Cara Tenenbaum

Cara is a seasoned health policy expert, advocate, and writer with almost two decades of health policy experience. That includes experience in the patient advocacy field, having been the head of policy for a small non-profit focusing on women’s health. There, she handled…

Cara is a seasoned health policy expert, advocate, and writer with almost two decades of health policy experience. That includes experience in the patient advocacy field, having been the head of policy for a small non-profit focusing on women’s health. There, she handled all advocacy, including appropriations, authorizing legislation, drafting testimony, presenting testimony, preparing regulatory comment letters and working with all operating divisions of HHS, as needed. Additionally, she functioned as spokesperson for the organization, appearing on national and international TV as well as in print. Cara was at the FDA for six years, working in both the Office of External Affairs in the Commissioner’s Office and the Office of the Center Director in the Center for Devices and Radiological Health. There, Cara worked on issues at the intersection of policy, legislation and advocacy, helping further the Agency’s agenda with patient and provider groups.

She has worked or volunteered in the pro-choice field off and on for 20 years, including being a clinic escort, volunteering with abortion funds, and doing patient counseling at an abortion clinic.

Cara has numerous legal publications, and provides off and on the record interviews to press.

She holds a JD and MBA from Case Western Reserve University and a BA in Economics from the University of Maryland, College Park.

Photo of Allison Kwon Allison Kwon

Allison Kwon supports Crowell Health Solutions, a strategic consulting firm affiliated with Crowell & Moring, to help clients pursue and deliver innovative alternatives to the traditional approaches of providing and paying for health care, including through digital health, health equity, and value-based health…

Allison Kwon supports Crowell Health Solutions, a strategic consulting firm affiliated with Crowell & Moring, to help clients pursue and deliver innovative alternatives to the traditional approaches of providing and paying for health care, including through digital health, health equity, and value-based health care. She is a health care policy consultant in the Washington, D.C. office.