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Transforming Clinical Trials

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March 28, 2022

Clinical Trials Have Key Role in US “Cancer Moonshot” Initiative

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    The White House is moving forward with Cancer Moonshot, an ambitious plan with the goal of reducing the US death rate from cancer by at least 50% over the next quarter century.

    Oncology clinical trials comprise several key components of Moonshot. The National Cancer Institute (NCI) will connect underrepresented populations to clinical trials and build capacity in cancer control research in underserved communities. The primary goal is to increase referral and accrual of racial and ethnic minority populations to NCI-supported clinical trials.

    Key recommendations include enrollment of patients 65 and older with the following guidance:

    • Trial design
    • Recruitment strategies
    • Information collection
    • Developing and reporting more discrete age groups to encourage enrollment

    Moonshot also provides guidance on designing and conducting clinical trials with multiple expansion cohorts that allow for concurrent accrual of patients into different cohorts to assess safety, pharmacokinetics, and anti-tumor activity of first-in human cancer drugs.

    Additional guidance addresses master protocol design including information on what sponsors should submit to the US Food & Drug Administration (FDA) as part of these trial design approaches. It also directs how sponsors should interact with the FDA to facilitate efficient review and mitigate risks to patients.

    The Biden Administration said this approach can expedite the development of cancer treatments as they allow more than one investigational drug, more than one disease type and more than one patient population to be evaluated under a single clinical trial structure.

    New Legislation Eyes Minority Health Disparities

    President Joe Biden signed the John Lewis National Institute on Minority Health and Health Disparities (NIMHD) Research Endowment Revitalization Act. The new law allows for investing in universities conducting critical research into minority health disparities. Introduced by the late Georgia Congressman John Lewis, the bill ensures NIMHD continues to provide grants needed for this type of research.

    The goals of NIMHD’s Research Endowment Program include:

    • Promoting minority health and health disparities research capacity and infrastructure
    • Increasing the diversity and strength of the scientific workforce
    • Enhancing the recruitment and retention of individuals from health disparity populations that are underrepresented in the scientific workforce

    The signing of this legislation comes just weeks after legislation aimed at increasing diversity in clinical trials was introduced in the U.S. House of Representatives. The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act calls for improved reporting standards and increased resources. These include workshops and community health center grants to encourage more diverse participation and improve access to clinical trials.

    The Act comes at a time when the issue of disparities in healthcare is under the spotlight due to the pandemic. The goal is to increase trust in public health by ensuring treatments, interventions and cures are fully researched across racial and ethnic groups.

    FDA Issues Guidance on Tech Use in Clinical Trials

    The FDA has provided new recommendations to sponsors, investigators and other interested parties about the use of digital health technology (DHT) in clinical trials.

    The main areas of the FDA’s draft guidance are:

    • Description, selection, and rationale for DHT use in clinical trials
    • Verification, validation, and usability of DHTs
    • Evaluation of clinical endpoints and statistical analysis
    • Risk and other considerations when using DHTs
    • Record protection and retention

    The draft guidance spells out considerations that would be expected in the submission regarding the validation and verification of DHT hardware, DHT software, general-purpose computing platforms, as well as interoperability of connected systems with the DHT and usability studies on the DHT.

    The FDA also outlines the expectation that sponsors include in applications and explanation as to why the DHT its fit-for-purpose. The fit-for-purpose must be justified based on the disease or condition being researched, trial participant population, design of the clinical investigation, and the characteristics of the DHT that may influence trial participant use.