Researchers running clinical trials must comply with a complex system of regulations, ethical guidelines and international standards.
When this 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.
Good clinical practice guidelines – ICH GCP – are used by researchers across the world. The guidelines provide agreement on how to design and conduct a clinical trial. They aim to protect patients, and to test how safe and effective treatments are.
The current guidelines were originally designed by, and for, regulators and pharmaceutical companies to test the effectiveness of new drugs in trials and secure product registration.
But in the absence of any alternative guidelines, ICH GCP are now being used in a range of other settings and contexts for which they’re not always appropriate, in particular when the drug won’t be licensed.
New guidelines are urgently needed for trials where the current guidelines are not fit for purpose. The new guidelines should be:
- based on scientific evidence
- straightforward and simple
- adaptable to individual studies
- suitable and relevant for the multiple settings and contexts where trials are run, including low- and middle-income countries.
What we're doing
We’re establishing the Joint Initiative on Good Practice in Clinical Research with the Gates Foundation and the African Academy of Sciences.
Through the initiative, we want 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.
first workshop [PDF 124KB] looked at how the current guidelines could be improved, and at possible alternative approaches.
To help us develop the guidelines, we want to hear from a range of people and organisations across the world, including patients, researchers and other funders. We’ll be asking for input during 2019.
We’re currently setting up a development team and will publish more details about our planned work later this year.