Today, when the driving force in clinical trials accessibility is shifting to more efficiency, let us take a look at the evolution of the Clinical Trials accessibility when it was driven by transparency and knowledge sharing needs. During several years, different registries and databases were created to respond to the necessity of transparency and knowledge [...]
Today, when the driving force in clinical trials accessibility is shifting to more efficiency, let us take a look at the evolution of the Clinical Trials accessibility when it was driven by transparency and knowledge sharing needs.
During several years, different registries and databases were created to respond to the necessity of transparency and knowledge sharing largely accepted as a condition to the success in medical researches. Internationally, there are about 24 clinical trials registries and the most widely known and used so far are Clinicaltrials.gov, WHO’s International Clinical Trials Registry Platform, and the pharma industries databases with their unique access IFPMA Clinical Trials Portal.
Despite their agreement on the importance of registration and sharing, (worthwile to look at Why is Trial Registration Important?), there are differences in their points of view and the Ottawa group’s (an initiator of the transparency and sharing process). In addition there are surprising differences between US and EU. Indeed, a Historical perspective on the development of ClinicalTrials.gov, and an overview of FDA’s role in support of it show an undergoing effort started already in US in 1997. Since 2008 US legislation has also required the outcome reporting within 12 months after data for the last subject were publicly available. On the other hand, EudraCT, the mandatory European clinical trials registry became available to the public only since march 2011.
Here are the main dates for:
Important launches:
1998-2000:
International Standard Randomized Controlled Trial Number (ISRCTN) was created by a working group of researchers
2000:
ClinicalTrials.gov launched by the US National Library of Medicine on behalf of US National Institutes of Health in response to the 1997 FDA Modernization Act
2005:
International Clinical Trials Registry Platform (ISTRP) launched by WHO
2005:
IFPMA Clinical Trials Portal launched by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
2011:
EU Clinical Trials Register launched by the European Medicines Agency
Important facts:
2004:
The Ottawa Group reached global consensus on trial registration followed by the Ottawa Statement
2004:
The International Committee of the Medical Journal Editors announced that any clinical trial must be registered by September 2005 in public clinical trials
2005:
Global industry position on disclosure of information about clinical trials by the International Federation of Pharmaceutical Manufacturers and Associations. Available on the IFPMA Clinical Trials Portal
2006:
The WHO Policy announced a “Minimum 20 items Trial Registration Dataset”
2008:
Starting 2008, all clinical trials registered in the Clinicaltrials.gov database have to report key results of the main outcomes no later than 12 months after data for the last subject are received
2011:
The EU Clinical Trials Register recognised as “primary registry” of the WHO’s International Clinical Trials Registry Platform.
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