Guidance

What does this topic cover?

Advocacy for transparency and integrity in research is about calling for improvements in the way that research is prioritized, funded, planned, conducted and published. 

It touches upon key topics such as: 

• The need for unconflicted and independent research
• Clinical trial transparency
• Access to clinical study reports (CSRs)
• Reducing research waste
• Addressing research misconduct
• Highlighting gaps in evidence

Why does it matter?

These issues go to the core of Cochrane: without access to relevant, unconflicted and accurate data, our reviews will not be of the quality we want. 

Our vision for this area of work is a world in which all information needed for high quality reviews is accurate, unconflicted and accessible; that gaps in evidence are defined and used for guiding decisions on investment in research; and that the research community also contributes to reducing waste.

Clinical trial transparency

Registering and reporting the results of clinical trials is an ethical, and often legal, responsibility. However, it is well documented that the results of many studies are never published.

Cochrane's systematic reviews rely upon the results of clinical trials. To assess the effectiveness and safety of healthcare interventions, we need to know what trials were done, how they were conducted and what their findings were. Without access to detailed information from all clinical trials, we cannot have a full picture of the evidence.

All clinical trials should be registered and reported in accordance with the following:

• Clinical trials registered, with protocols, prior to start date
  Studies should be added to a publicly accessible registry (which meets WHO standards) before the first participant is recruited, with a detailed protocol. Information on the registry should be kept up-to-date and be accurate for the duration of the trial.
• Summary results posted within 12 months
  A summary of results should be posted to the registry within 12 months of the study ending. This will ensure that results are publicly available as soon as possible. Reports must be clear, complete, and accurate.
• Academic publication
  Findings of the study should also be published in an academic journal as soon as possible – and at least within 24 months. The Trial ID or registry identifier code should be included in the publication, so that it can easily be linked to the registry record.

Cochrane positions and policies

• Conflict of interest policy for Cochrane Library content

Cochrane statements and publications

• Cochrane's statement to the 74th World Health Assembly (June 2021)
  Cochrane’s statement in response to the agenda item on global health emergencies, which emphasised the importance of clinical trial transparency within the context of global health crises.
• Cochrane shows support for WHO-ICMRA statement on transparency and data integrity (May 2021)
  Cochrane’s Editor in Chief supports a joint WHO-ICMRA statement which calls on the pharmaceutical industry to increase transparency and access to clinical data for all new medicines and vaccines.
• Cochrane's statement to the 73rd World Health Assembly (May 2020)
  A statement to the 73rd World Health Assembly, which focused on COVID-19. In this statement, Cochrane drew attention to the amount of research being published on COVID-19 and the need for evidence synthesis to help make sense of findings, as well as the importance of trial transparency, so that results can be accessed.
• Cochrane's statement in support of EMA’s clinical study report transparency policy (January 2020)
  A statement supporting the European Medicines Agency on their policy to proactively publish clinical study reports. 
• Cochrane statement in support of European regulators as they urge clinical trial sponsors to share their results (10 July 2019)
  A statement calling on clinical trial sponsors – particularly within academia – to meet the reporting obligations for their studies.
• Clinical Trial Transparency – A Guide for Policy Makers (2017)
  A report co-published by Cochrane, TranspariMED, Transparency International and the Collaboration for Research Integrity and Transparency that highlights the dangers of inadequate reporting of clinical trials and makes policy recommendations to improve the situation.