New global guidelines offer recommendations for more effective and equitable clinical trials

A set of guidelines aimed at improving the organization, conduct and supervision of clinical trials in countries at different income levels was released today, with the aim of strengthening the medical research and development infrastructure to ensure the accelerated availability of safe, effective and affordable health interventions to individuals around the world.

These recommendations represent comprehensive guidance for health authorities, regulators and funders to adopt best practices in facilitating clinical trials, focusing on challenges that hinder quality, diversity of participants and poor infrastructure, which lead to inefficient consumption of time and resources.

The gaps between high-and low-income countries are highlighted in the number of clinical trials, where in 2022 more than 27,000 trials were conducted in high-income countries, compared to only about 24,000 in low-and middle-income countries. It should be noted that many of the experiments conducted in developing countries targeted the diseases prevalent in them, but their results were later used to obtain permits in high-income countries without directly benefiting from the experiments for these countries.

Specialists in Scientific Affairs emphasize that the promotion of State-led research and development and the inclusion of clinical trials in routine health services will accelerate the use of safe and fair medical interventions, which contributes to improving the health of individuals in general. The new guidelines emphasize the importance of promoting the diversity of participants in clinical trials to include broad segments of the population, ensuring that the benefit reaches as many individuals as possible.

According to recent data, less than 5% of clinical trials involved pregnant women and only 13% involved children, which negatively affects the quality of medical evidence available to these two groups, and leads to cautious and inadequate treatment that may harm their health. The guidelines seek to address this challenge by establishing specific procedures for the participation of underrepresented groups such as pregnant women and children from the beginning of trials, while ensuring that appropriate safety standards are available for these groups, by reviewing previous interventions or accelerating preclinical studies.

The guidelines also call for putting patient and community involvement at the heart of the organization of clinical trials to ensure that research planning is aligned with the needs of the public and to enhance public confidence. One of the main objectives of these new directives is also to strengthen the National Research and development infrastructure by providing sustainable funding, which contributes to better supporting medical decision-making, accelerating the arrival of Health Innovations, and building a strong and effective research environment at the national and international levels.