New Joint Initiative For More Efficient, Adaptable Clinical Practice Guidelines

Wellcome Trust, the Bill & Melinda Gates Foundation and the African Academy of Sciences have joined together in a new initiative to make clinical practice guidelines more efficient and adaptable for clinical trials that require less stringent approaches, such as those that take place during infectious disease outbreaks. Additionally, by applying a more flexible approach towards the application of these guidelines, the initiative also hopes to make them “future proof,” or able to better incorporate new technologies.

The good practice guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH GCP) are currently “used by researchers across the world,” and they “provide agreement on how to design and conduct a clinical trial,” the Wellcome website explains.

“The current guidelines,” it says, “were originally designed by, and for, regulators and pharmaceutical companies” for drugs intended to be licensed, but are “now being used in a range of other settings and contexts for which they’re not always appropriate.”

The new joint initiative aims to address the challenges of applying the guidelines in settings and contexts that require less stringent approaches, such as infectious disease outbreaks, community-based trials and innovative trial designs, according to a summary [pdf] of the first joint workshop of the initiative.

When the application of ICH GCP works well, “it creates a supportive environment for research by protecting patients, building public trust and driving innovation. When it works badly, it creates confusion, higher costs and delays,” the website explains.

“New guidelines are urgently needed for trials where the current guidelines are not fit for purpose,” it says. The new initiative therefore aims to:

  • “develop new clinical practice guidelines for trials of health interventions that won’t be licensed
  • advocate for policymakers, regulators, international standards bodies and other funders to implement the new guidelines
  • support researchers to use them in practice.”

Next Steps

The Wellcome website states that to help develop the guidelines, the new initiative “want[s] to hear from a range of people and organisations across the world, including patients, researchers and other funders,” and will “be asking for input during 2019.”

“Good to hear,” Kent Buse, chief of strategic policy directions at UNAIDS, said in a tweet.

“I hope that public interest #NGOs will be consulted,” he said, tagging a range of civil society stakeholders.

The initiative will publish more details on its planned work on the Wellcome website later this year.

First Joint Workshop: Decision Trees and New Technologies

Wellcome Trust, the Gates Foundation and the Academy of Medical Sciences “held a joint workshop to bring together a range of perspectives to discuss the current guidelines, how the guidelines might be improved in the future, review potential revisions, and discuss possible alternative approaches,” the workshop summary explained.

Delegates of the joint initiative present at the workshop “acknowledged the importance of guidance to foster good clinical practice, but felt that over-interpretation and lack of clarity has caused compliance with existing ICH GCP guidelines to become a tick-box exercise.”

They also explained that adhering to the stringent guidelines is impractical in certain situations. For example, one delegate said that when applying these guidelines during an Ebola outbreak, “all materials had to be sterilised before leaving the treatment tent and so researchers had to photograph consent forms on a tablet in a protective case that could later be dropped into bleach.”

The delegates instead “called for guidance that does more to encourage critical thinking about which measures and processes are important in any particular trial while removing unnecessary bureaucracy.”

They expressed support for a “decision tree” approach, “perhaps through a computerised app, that could sit alongside the core principles and help relate them to a range of research settings. By answering a series of linked questions about trial type, setting and risk, researchers could understand what is, and is not, needed to conduct the trial safely.”

Participants also “emphasised the importance of future-proofing guidance,” as “overly prescriptive guidelines can stifle innovation as technology advances.” They noted that “instead, describing ‘what good looks like’ will allow researchers to adapt this to different techniques and technologies.”

The workshop summary concluded that “[t]his is a crucial time, with major developments occurring in trial design as well as technological advances in how data are stored, collected and shared.”

“The coming artificial intelligence (AI) revolution,” it said, “may also transform the design and implementation of clinical trials.”


Image Credits: Wellcome.

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