WHO issues clinical trial guidelines designed to improve access to meds

New guidelines designed to “embed” studies in routine clinical and public health services will ensure faster and more equitable access to drugs, according to the World Health Organization (WHO).

The Switzerland-based global healthcare body released the guidelines in late September, aiming to help national regulators ensure that studies run in their territories are more inclusive and generate high-quality data.

WHO chief scientist Jeremy Farrar said, “Strengthening country-led research and development and embedding clinical trials in routine clinical and public health services will ensure faster and more equitable access to safe and effective interventions, helping people become healthier.

“This new guidance aims to improve the diversity of trial participants to ensure research benefits the broadest range of people possible, decisively moving away from a one-size-fits-all approach.”

Recommendations

The guidelines include advice on how to best facilitate clinical trials to generate evidence on health interventions as well as recommendations about participant and community engagement.

In addition, the WHO wants to address the under representation of pregnant women and children in drug research as fewer than 5% of pregnant women are included in trials and only 13% included children, according to 2022 data.

According to the guidelines, “In general, at-risk populations should be involved from the earliest stages. To facilitate this, safety should be assessed as an initial priority, for instance, by reviewing comparable interventions or expediting pre-clinical studies for these groups. Appropriate procedures for consent and assent are key, particularly for children.”

Access to medicines

The WHO also urges national regulators to look at how they can ensure products tested in their territories go on to be available in those territories.

“Inequities in post-trial access to interventions tested in clinical trials also remain a major concern, especially in relation to low- and middle-income countries (LMICs).

“Indeed, there have been examples of trials where the disease burden in LMICs led to them being targeted for inclusion in clinical trials, yet these data were then used to file for marketing authorization in high income countries or high-resource settings, often leading to availability of interventions in the latter but not the former,” the WHO noted.

Unsplash/Aaron Burden