The regulatory landscape surrounding clinical trial data is growing more complex every year, with evolving regulations clinical researchers should take care to track .
As noted by Marisol Cooke, Ivan Montoya, and Katie Fail of Grant Thornton: “[R]egulations affecting the disclosure of clinical trial data exist in approximately 90 countries, each with their own health authority and requirements about the level of detail, scope and timing of disclosures. Currently, there are more than 30 clinical trial registries, with an average of two new registries launched every year.”
Amid this backdrop, recent guidance documents and policy proposals have emerged in influential regions, including the United States, the European Union, Canada, and beyond. These initiatives are poised to exert significant influence over data collection practices in clinical trials in the forthcoming year.
This article presents an overview of the pivotal regulatory developments that researchers should monitor closely in 2024.
United States: 2023 NIH Data Management and Sharing Policy
In January 2023, the National Institutes of Health (NIH) issued an updated policy which now mandates the adoption of a DMS framework for research linked to various initiatives, including ZIA projects, clinical protocols slated for IC initial scientific review, and Genomic Data Sharing endeavors.
According to NIH Acting Director Lawrence A. Tabak, “the DMS policy establishes the expectation that data sharing is a fundamental component of the research process and maximizes the public’s access to research results that arise from NIH-funded research.” Tabak emphasizes the NIH’s strong encouragement for the research community to fully embrace DMS plans, positioning them as an integral aspect of contemporary research grant planning and administration.
Satrajit Ghosh, a distinguished research scientist at MIT, underscores the significance of this NIH policy, highlighting that clinical researchers find themselves at a pivotal juncture. The abundance of cutting-edge data storage and analysis infrastructure available today highlights the urgency and importance of embracing this new era of data management and sharing in the field of clinical research.
European Union: The ACT EU Work Plan
In Europe, researchers have been grappling with an ongoing regulatory challenge centered around the Accelerating Clinical Trials in the EU (ACT EU) multi-year work plan, extending through 2026.
Launched in January 2022, this comprehensive plan is laser-focused on 10 critical priority actions strategically designed to revolutionize the landscape of clinical trials within the European Union.
Two of those priorities have rapidly approaching key milestones:
- Priority Action 2: Involves the successful implementation of clinical trial regulations throughout the EU. Notably, it is set to oversee the introduction of a “one-stop shop” tailored to support academic sponsors, expected to be fully operational by Q1 2024.
- Priority Action 8: Pertains to the pioneering development of innovative trial designs and methodologies. It is slated to culminate in the publication of a comprehensive trial methodologies roadmap by Q4 2023.
Björn Eriksson, the General Director of the Swedish Medical Products Agency and distinguished member of the Heads of Medicines Agencies Management Group, says such an ambitious, multi-year project across member states “will support bigger, better and faster clinical trials for better medicines for patients and drive innovation and investment.”
European Union: Proposal to Reform Pharmaceutical Legislation
In April 2023, the European Commission adopted a proposal for a new directive and regulation, slated to overhaul and supersede the existing general pharmaceutical legislation in place.
The majority of the proposed alterations center on areas beyond clinical research, but some noteworthy revisions demand attention. These include a proposal to reduce the period of Regulatory Data Protection (RDP) to encourage the development of new therapies, and stricter guidelines for safeguarding patient data.
Some stakeholders, including major pharmaceutical companies, have “expressed their concerns about the Commission’s proposal to modulate and reduce the Regulatory Data Protection (RDP) period from eight (8) to six (6) years, since the eight-year protection has been crucial for steering the development of innovative therapies,” EY’s Stephanos Mitsios writes.
Further, Applied Clinical Trials’ reporter Peter O’Donnell highlights that the revisions call for “a tighter policy focus” on the protection of patient data, especially when those clinical trials are conducted outside of the EU, and that research organizations “must adequately demonstrate they fully met the principles of good clinical practice.”
These developments mark a crucial juncture in pharmaceutical legislation and clinical research, warranting close attention and analysis.
Canada: Draft Guidance on Using Disaggregated Data
In late 2022, Health Canada unveiled a pivotal initiative in the form of its “Draft guidance document on the collection and analysis of disaggregated data in clinical trials.”
The forward-looking guidance proposes regulations that will require sponsors to break down patient data by sex, age, and race or ethnicity. The objective is to champion historically underrepresented patient groups, shielding them from ineffective treatments and adverse side effects.
“We absolutely need to do better,” said Supriya Sharma, esteemed Chief Medical Advisor at Health Canada, emphasizing the pressing need for improvement when the draft guidance was initially released.
“I can’t go back and correct or change the history,” she added. “What I can say is that now there really is a genuine concerted effort, not only in Canada, but internationally, to make sure they’re adequately represented.”
Watch for this draft to attain official guidance status, anticipated in the late stages of 2023 or early 2024. This signifies a significant stride towards enhancing inclusivity and precision in clinical trials.
Looking Ahead: More Regulations Clinical Researchers Should Track
In addition to the previously mentioned developments, there are several other noteworthy trends to monitor. One significant change is unfolding in the United Kingdom, where authorities are crafting a replacement law for the European Union’s General Data Protection Regulation (GDPR). This transition becomes particularly pertinent as the GDPR will cease to apply after December 2023, in accordance with the Brexit agreement.
It’s still an open question as to whether the U.K.’s regulations will meet the EU’s standards, Rhino Health’s Matt McKinley writes in Clinical Trials Arena. “Otherwise, there will be additional hurdles implemented for UK researchers wishing to handle the personal information of EU subjects.”
Meanwhile, the technology capable of storing, sharing, and parsing trial data grows by leaps and bounds, Cooke and colleagues at Grant Thornton note: “Regulatory bodies across the globe are now shining a new light on the need for global harmonization for disclosure policies and procedures.
“… All the intensified efforts to ensure data harmonization, implement standardized data formats, and develop secure platforms for controlled access to individual patient-level data for secondary analysis are designed to ensure consistency in reporting and strike a clear balance between making data sharing easier and protecting patient privacy.”
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