A new publication from the Collaboration for Research Integrity and Transparency (CRIT) at Yale Law School and AllTrials supporters Transparency International, TranspariMED and Cochrane calls on governments to ensure that patients, doctors, and scientists can access the full results of all clinical trials.
The groups warn that the current lack of access to complete, unbiased and undistorted evidence of the benefits and harms of drugs, medical devices and treatments harms patients, prevents public health agencies from making informed decisions, wastes public health funds, slows down medical progress, and exposes shareholders to substantial risks.
The report finds that despite strong global standards set by the World Health Organisation and by the 735 organisations that are part of AllTrials, and positive regulatory moves at regional and national levels, in many instances rules are being ignored due to a lack of enforcement.
The TI-PHP, TranspariMED, Cochrane and CRIT paper calls on governments to ensure that all clinical trials conducted in their countries fully adhere to global transparency standards:
1. Trial registration: All clinical trials must be registered before they start.
2. Summary results posting: Headline results must be made public within 12 months.
3. Full trial reports: Detailed trial findings must be proactively disclosed.
4. Academic publication: Trial results must be published in academic journals or made freely available in appropriate trials registries or databases (preferably both).
5. Individual participant data sharing: Frameworks, standards, policy and legislation that enable effective, vigilant individual participant data sharing should be established.