Quiet Diplomacy Moving Clinical Trials Regulation Forward at the Global Level

One of the highlights of the recent meeting of that rather remote body, the International Council for Harmonization (ICH), was the formal endorsement of a new draft of its guideline on good clinical practice (GCP), signalling its release for wide consultation in a bid to extend mutual acceptance of clinical trial data around the world.

ICH has grown in size and in stature since it was set up more than three decades ago by Europe, the US, and Japan to bring some alignment to their respective regulatory systems. The resulting high-level backing and strategic cooperation by medicines authorities and pharmaceutical companies has over the years become a major–but somewhat anonymous—influence on the evolution of the rules governing drug approvals, not least in relation to clinical trials. Expert working groups conduct scrupulous discussions upstream of national or regional rule-making, frequently resulting in principles that have been subsequently endorsed downstream, bringing greater commonality to established practice in drug development.

The new GCP guideline—an update of earlier ICH guidance that dates back to 1995—offers principles relating to the changing disciplines, designs, and methodologies of clinical trials, with the explicit aim of encouraging the use of innovation and technologies that could make clinical trials more efficient. Its wide scope covers the obvious aspects of the duties and obligations of institutional review boards (IRBs) and ethics committees, investigators and sponsors, and the issues related to data governance. But it also provides for the development of annexes "to respond to stakeholder needs and to address emerging innovations in trial design and conduct."

The aim is "keeping clinical trial conduct in line with advancing science and technological developments." It says it is intended to support "efficient approaches to trial design and conduct"—including the use of innovative digital health technologies, such as wearables and sensors. "Such technologies can be incorporated into existing healthcare infrastructures and enable the use of a variety of relevant data sources in clinical trials," it goes on. The use of innovative clinical trial designs and technologies may help include diverse patient populations, and enable wider participation, the guideline adds. But it insists that the use of technology in the conduct of clinical trials should be adapted to fit the participant characteristics and the particular trial design.

The consultation that ICH has now opened on this draft, but the actual mechanisms for comment will be established by the regulatory authorities in each participating country or region. However, the text is already available on the ICH website.¹

Owing to the significance of this guideline for so many aspects of clinical development, ICH says it expects "an extraordinarily large number of comments," and even offers advice on how the comment process itself can be made more efficient. It urges respondents to prioritize their comments, provide justification and examples to support suggested changes, and to "focus on key issues." But it will particularly welcome insights on where its draft does not adequately accommodate "technological innovations and design elements that are being explored to make clinical trials more efficient."

The influence of ICH is wider than merely GCP. Its June meeting also identified new topics for harmonization, including a new efficacy guideline on a systematic approach to designing, conducting, analyzing, and presenting patient preference studies to supplement information about the assessment of a product or inform drug development and related decisions. It also decided to progress a new reflection paper on international harmonization of real-world evidence terminology, aimed at convergence of general principles on planning and reportingstudies using real-world data, with a focus on effectiveness of medicines. Another initiative agreed was to create a new ICH discussion group on cell and gene therapies as a technical discussion forum for issues related to ICH harmonization efforts in the field. And the approval was reported of the concept paper for a new guideline on inclusion of pregnant and breastfeeding individuals in clinical trials. An updated questions and answers document on the ICH guideline on electronic transmission of individual case safety reports has also been adopted.

The June meeting also saw 14 of the ICH working groups hold in-person meetings, and marked growth in the membership of ICH too, as it welcomed Egypt as the first African regulatory authority to join ICH, along with Nigeria's NAFDAC as a new ICH Observer. Over the years, regulators have joined from Latin America, Asia, and the Middle East, alongside Canada and Switzerland. There are now 21 members and 36 observers. ICH is also increasing its outreach to patients, with a session at the DIA Annual Meeting in Boston next week on what’s in it for patients in ICH's work. The next major ICH meeting is planned for late October in Prague.

Reference

1. https://www.ich.org/news/ich-e6r3-draft-guideline-presentation-available-now-ich-website

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium