Upgrading Standards for Clinical Trials

Some of the world’s largest funders for medical research and international NGOs are in agreement on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly. The funders for clinical trials have also agreed to monitor compliance with registration requirements and to develop systems capable of monitoring reported results.

Today, about 50 percent of clinical trials go unreported, according to several studies, often because the results are negative. These unreported trial results leave an incomplete and potentially misleading picture of the risks and benefits of vaccines, drugs, and medical devices, and can lead to the use of suboptimal or even harmful products.

Medical researchers and international NGOs supporting the standards upgrade include:

  • Indian Council of Medical Research
  • Norwegian Research Council
  • UK Medical Research Council
  • Medecins Sans Frontieres
  • Epicentre
  • PATH
  • Coalition for Epidemic Preparedness Innovations
  • Institut Pasteur
  • Bill & Melinda Gates Foundation
  • Wellcome Trust

 

These organizations have agreed to develop and implement policies within the next 12 months that require all trials they fund, co-fund, sponsor, or support to be registered in a publicly available registry. They also agreed that all of the results would be disclosed within specified timeframes on the registry and/or by publication in a scientific journal.

Most of the trials and their results will be accessible via WHO’s International Clinical Trials Registry Platform www.who.int/ictrp/networki/en, a global database of clinical trials that compiles data from 17 registries around the world including the U.S www.clinicaltrials.gov, European Union’s Clinical Trials Register, Chinese and Indian Clinical Trial Registries, and many other registries worldwide.