WHO - Guidance for Best Practices for Clinical Trials
We are delighted to share that the World Health Organization (WHO) has officially launched its “Guidance for Best Practices for Clinical Trials” which significantly incorporates principles developed by the Good Clinical Trials Collaborative (GCTC). This newly established guidance by the WHO marks a significant advancement in the global standard for clinical research, ensuring that trials are designed and conducted with scientific rigor and participant well-being as the highest priorities.
Key Features of the WHO Guidance:
- Scientifically Sound and Ethical Design: Trials are structured to address relevant scientific questions and prioritize participant safety and ethical standards.
- Respect for Participant Rights: Emphasis is placed on protecting the rights and welfare of all participants involved.
- Transparency and Collaboration: The guidelines encourage clear communication and partnership among stakeholders, ensuring transparency throughout the trial process.
- Contextual Feasibility: The guidance considers varying resource settings to ensure that clinical trials are practical and applicable globally.
- Efficient and Effective Quality Management: Focus on maintaining trial quality without unnecessary administrative burdens, allowing for better resource utilization.
The guidance has been developed through a thorough consultative process involving patient advocates, healthcare professionals, regulatory bodies, academia, and industry representatives. By adopting these guidelines, the WHO aims to foster a more inclusive, high-quality clinical trial environment that addresses global health priorities, including the needs of underrepresented and vulnerable populations.
Download the document: Guidance for best practices for clinical trials
Learn more about the Good Clinical Trials Collaborative: Home | Goodtrials
Returning to the principles of good randomized clinical trials
In this introductory webinar, attendees, we about the rationale for and development of the Collaborative’s guidance, along with ongoing activities to promote and implement it.
The webinar included experts from diverse areas of the clinical trial ecosystem, who added their perspectives on the value of and uses for the guidance to address current challenges in RCTs.
Webinar en Español
"Trabajando juntos por una mejor investigación en salud en Latinoamérica y el Caribe"
"Trabajando juntos por una mejor investigación en salud en Latinoamérica y el Caribe" aborda la importancia de la colaboración regional para mejorar la investigación en salud. Se discuten estrategias para fortalecer la capacidad de investigación, la financiación y la implementación de políticas de salud efectivas. Los panelistas destacan casos de éxito y desafíos comunes en la región, subrayando la necesidad de trabajar en conjunto para enfrentar problemas de salud pública y mejorar los sistemas de salud. Para más contenido en español sobre esta y más iniciativas de GCTC y TGHN visita el LAC HUB https://lac.tghn.org/
Guidance for good clinical trials
The Good Clinical Trials Collaborative’s new film sees experts discuss the importance of high-quality trials in advancing global healthcare and the role of good guidance in influencing change. They offer valuable insights on the significance of good trials, their critical attributes and how they can be improved.
The film also introduces the Collaborative’s guidance and delves into its five principles designed to support randomized controlled trials to be informative, ethical and efficient.
Enabling "Good" Clinical Research in LMICs with the Good Clinical Trials Collaborative
Clinical trials are a cornerstone of medical advancement and improved public health. However, a complex array of challenges around resources, infrastructure, knowledge, and governance are hampering global efforts to conduct high-quality clinical trials. The result? A suboptimal evidence base and significant research waste.
The 5 Principles to Guide the Future of Randomized Clinical Trials
The number of clinical trials conducted across the world is expected to rise in coming years on the back of continued demand for new innovative products and medical technologies. This could be a positive trend for global healthcare, but what tools do we have to avoid a related rise in research waste?
Fast tracking informative clinical trials: lessons for mental health
The COVID-19 pandemic has put clinical research and how it is organised, implemented, and disseminated under scrutiny, and has revealed not only capabilities, but also shortcomings and inefficiencies. Many of these observations reflected or magnified problems that preceded the pandemic in many areas of medicine and are likely to remain relevant in the years that follow. For example, it has been highlighted that more than 95% of clinical trials on COVID-19 were underpowered or poorly designed and thus had no possibility of providing meaningful evidence. This problem sounds familiar to anybody observing the clinical trials landscape in psychiatry.
Accelerating clinical trials: time to turn words into action
As countries begin to navigate a post-pandemic world and health systems struggle to deal with the burden of disease affecting the populations they serve, high-quality randomised clinical trials are more essential than ever to ensure that the limited resources available are used most efficiently to deliver effective health interventions. Randomised clinical trials provide a sound method to understand whether, how well, and for whom health interventions are effective. The evidence such trials generate informs regulatory licensing, health-care policy, and individual clinical care.
The Collaborative submits commentary on draft GCP E6R(3) guidelines to EMA
On 27 September, the Good Clinical Trials Collaborative submitted its commentary on the draft Good Clinical Practice (GCP) E6R(3) guidelines to the European Medicines Agency, in response to the public consultation launched by the International Council of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in May 2023.
Our submission, comprising a letter and an Appendix, was supported by the Coalition for Reducing Bureaucracy in Clinical Trials and the Biomedical Alliance in Europe. Together, the two entities represent more than 50 medical societies and patient advocacy and research organisations, as well as more than 400,000 researchers and healthcare professionals.
The letter can be read in full here
"Time to turn words into action" - a response to O'Shaughnessy review
Following Lord O’Shaughnessy’s new review into commercial clinical trials, senior lead Professor Sir Martin Landray has co-authored an article for The Lancet exploring how the UK can deliver on the recommendations outlined in the review.
Read the response to the O'Shaughnessy review here