What does all trials registered and reported mean? | All Trials

"Clinical trials are investigations designed to assess the effects – wanted and unwanted – of healthcare interventions. The Declaration of Helsinki, which is the World Medical Association’s statement of principles for medical research involving people, states that every investigator running a clinical trial should register it and report its results. Millions of volunteers have participated in clinical trials to help find out more about the effects of treatments on disease, yet that important ethical principle about reporting has been widely ignored. This is what led to the AllTrials campaign in January 2013, a campaign which is now supported by thousands of individual patients, clinicians and researchers across the world, and by hundreds of organisations representing millions of people. This document sets out more information about achieving a situation globally where all trials are registered and results reported. It is an achievement that will involve regulators and registries, clinical trial funders, universities and institutes, professional and learned societies and medical journals, patients and researchers. This document is part of a continuing discussion which many different organisations are working on elaborating further over coming weeks and months. Please email views and contributions to: alltrials@senseaboutscience.org What trial information needs to be registered and reported? There are four levels of information in clinical trial reporting: (1) knowledge that a trial has been conducted, from a clinical trials register; (2) a brief summary of the trial’s results; (3) full details about the trial’s methods and results; (4) individual patient data from the trial. The AllTrials campaign is concerned with the first three. There are now initiatives in many countries to work out how individual patient data can be shared with other researchers."