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Classified in: Health
Subject: SVY

Crowell Health Solutions Examines the Adoption of Decentralized Clinical Trials and Provides Policy Recommendations


WASHINGTON, Nov. 28, 2023 /PRNewswire/ -- 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:

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.

Media Contact:
Email: [email protected]

SOURCE Crowell Health Solutions


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