For the 152nd Session of the WHO Executive Board meeting, ESMO submitted an official statement on the agenda item ‘Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination’, accompanied by a report from the WHO Director General.
As the leading professional organisation for medical oncology, counting more than 28,000 professional medical oncologists who treat cancer patients and perform clinical trials, ESMO supported the WHO proposal to coordinate the development of normative guidance for all aspects of clinical trials, including expanding the ‘International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’ guidelines, and most importantly to include health care professionals in their development.
ESMO also supported the WHO proposal of comprehensive mapping of national clinical trial infrastructures, which should include not-for-profit cooperative oncology groups. ESMO requested that indicators to track progress be included in the WHO self-assessment tools for use in the clinical trial ecosystem.
ESMO said it stands ready to support the design of robust WHO guidance on clinical trials because of their critical role in facilitating innovative research and delivering effective treatments.
In 2022, ESMO responded with written input to the WHO Consultation on Strengthening Clinical Trials that fed into this WHO agenda item. We recommended that any WHO international guidelines on clinical trials should:
- Enable the regulatory environment by ensuring international guidance respect the principles and high standards defined by the Declaration of Helsinki and the guidelines for Good Clinical Practice, as well as national and local regulations that guarantee patients' safety and rights, data protection, and the scientific integrity of data and its sharing.
- Protect and foster independent academic clinical research by ensuring an efficient legal and funding framework that can optimize novel therapeutic multidisciplinary strategies and investigate important, but less commercially attractive, research areas and health issues, such as rare cancers.
- Streamline the clinical trials process by simplifying, decentralizing, and reducing bureaucratic requirements which impede advances in scientific research, and are especially challenging for non-commercial trials.
The WHO Resolution on Strengthening Clinical Trials (WHA75.8) was adopted at the 2022 World Health Assembly.
The input from ESMO, as well as other stakeholders, to the 2022 WHO Consultation on Strengthening Clinical Trials can be found on the WHO website: Implementation of the resolution on clinical trials WHA 75.8.
In addition, WHO published a supplementary report with more extensive summaries of the inputs received to the Consultation, which is available here.