ASCO's 4 Key Recommendations to Enhance Access to Cancer Clinical Trials

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A research statement published by the American Society of Clinical Oncology (ASCO) outlines 4 recommendations to improve access to cancer clinical trials through the incorporation of decentralization elements.¹

The statement was published in the Journal of Clinical Oncology and includes 1 recommendation specifically for the FDA, along with 3 others for the broader research community.

The task force identified FDA Form 1572 as a significant regulatory barrier due to its vague language about direct and significant contributions to data. This vagueness often leads research sponsors to require every provider treating a trial participant to be listed on the form, resulting in extensive administrative demands and potential treatment delays.

“I have seen firsthand, patients participating in trials are required to drive 3 to 4 hours for routine testing that could be done at a community facility, but because they are participating in this potentially life-saving clinical trial, they have to bear the additional burden of traveling to a cancer center,” said Ramya Thota, MBBS, FASCO, co-author of the statement and a member of the multistakeholder group that made the recommendations, in a press release.² “This leads to needing childcare, time away from work, and many other issues, often causing patients, especially those in lower-income areas, to reject or drop out of trial participation.”

The overuse and misapplication of Form 1572 often leads to many regulatory requirements and administrative burdens that impact patient care, as well as the research workforce. Simplifying Form 1572 requirements and reducing unnecessary documentation will help to alleviate these burdens and make trials more accessible and efficient.¹

Here is a detailed overview of each recommendation:

FDA Public-Private Partnership

The first recommendation states that the FDA should lead a public-private partnership with the research community to develop uniform standards and optimal solutions to minimize regulatory and administrative burdens, thereby enabling local access to clinical trials. This collaboration should include diverse stakeholders, including regulatory experts, trial operations experts, community-based sites, and patient research advocates.

In the recommendation, it states that harmonization efforts should be promoted and should include the Office for Human Research Protections to streamline processes for federally funded work.

The FDA has a proven track record and a global influence with initiatives like the Clinical Trial Transformation Initiative, demonstrating its capability to gain consensus and lead effectively, and the Oncology Center of Excellence's Project Orbis, which works internationally to benefit global trials.

Flexible Protocols by Sponsors and CROs

In the second recommendation, it is stated that sponsors and contract research organizations (CROs) should create protocols that provide clarity and accommodate flexible approaches to enable local trial participation. These protocols should promote consistent regulatory data collection and documentation for stakeholders who are involved as this is essential to streamline processes and reduce administrative burdens.

Sponsors should leverage early discussions with the FDA to explore decentralized elements and address data quality risks, incorporating these insights into trial protocols.

Further, sponsors and CROs should utilize a pragmatic approach to data collection and the schedule of events to minimize patient burdens, improve access and inclusion, and enable equitable access to care closer to home.

Modernize Policies at Research Centers

The third recommendation says that research centers, networks, and sites should review and modernize their policies and procedures to ensure consistent regulatory data collection and documentation across all trials and sites. This will help minimize administrative and regulatory burdens and implement decentralized trial elements.

With this recommendation, sites should partner up to establish uniform standards and policies to reduce excessive documentation and enable local access to clinical trials. It is key that these standards are consistently applied across all trials, sponsors, and locations to ensure a streamlined process.

Moreover, the recommendation highlights the importance of ensuring that the site perspective is considered in discussions within the public-private partnership to delineate protocol elements requiring direct and significant contributions vs routine clinical care.

Streamlined Regulatory Mechanism

The last recommendation states that the research community should develop a streamlined, uniform mechanism for simplifying regulatory data collection and documentation. This mechanism should be consistently used across trials to minimize repetitive administrative tasks.

A centralized repository or platform should be considered along with this recommendation where investigators, sites, and healthcare facilities can upload and store their credentials, CVs, training certifications, etc. Examples include National Cancer Institute’s repository of credentials and TransCelerate's Investigator Registry, and Shared Investigator Platform, although these are not widely accessible or consistently used.

An alternative approach could be a trusted exchange network that could compile documentation directly from authoritative sources. This will allow investigators to manage personal documents and provide study-specific information. Health information technology organizations and software developers should explore strategies to repurpose existing data and automate documentation retrieval, such as medical licenses and certifications.

Some of the benefits of standardized approaches are distributed costs, sped-up implementation, and a reduced perception of risk, thereby benefiting the entire research enterprise. Through engaging key stakeholders through a public-private partnership, this will ensure consensus on the specifications and foster universal implementation.

“A pivotal aspect of research is keeping it patient-centered,” said Grzegorz S. Nowakowski, MD, co-author of the statement, said in a press release.2 “To keep it patient-centered, we need all patients to have access to trials, and these recommendations will move the community toward streamlined processes that enable decentralization.”

REFERENCES:

1. Thota R, Hurley PA, Miller TM, et al. Improving access to patient-focused, decentralized clinical trials requires streamlined regulatory requirements: an ASCO research statement. J Clin Oncol. Published online July 30, 2024. doi:10.1200/JCO.24.00961

2. ASCO research statement makes recommendations to streamline regulatory requirements to improve access to clinical trials. News release. American Society of Clinical Oncology. July 30, 2024. Accessed July 31, 2024. https://tinyurl.com/73bjcvu6