New trial registration standards19th May 2006
Research institutions and companies are being urged by the World Health Organization (WHO) to register all medical studies that test treatments on human beings, including the earliest studies, whether they involve healthy volunteers or patients.
As part of the International Clinical Trials Registry Platform, a major initiative aimed at standardizing the way information on medical studies is made available to the public through registration, WHO is also recommending that 20 key details be disclosed at the time studies are begun.
The initiative seeks to respond to growing public demands for transparency regarding all studies applying interventions to human participants, particularly highlighted by the drugs trials at London's Northwick Park Hospital which left six men seriously ill. Also, a recent survey in the US suggested that since medicines such as arthritis drug Vioxx were taken off the market because of higher heart attack risks, seven out of 10 doctors were more worried about prescribing.
Before making the recommendations announced today, the Registry Platform initiative consulted with all concerned stakeholders, including representatives from the biotechnology and device industries, pharmaceutical industry, patient and consumer groups, governments, medical journal editors, academia and ethics committees over a period of nearly two years.
Dr Timothy Evans, Assistant Director-General of the World Health Organization, said that registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants.
Registration is voluntary but there is a groundswell of policies aimed at encouraging registration of all clinical trials. In July 2005 the International Committee of Medical Journal Editors, a group representing 11 prestigious medical journals, instituted a policy whereby a scientific paper on clinical trial results cannot be published unless the trial had been recorded in a publicly-accessible registry at its outset.
Concerns have been raised by some groups that these new requirements could jeopardize academic or commercial competitive advantage if they apply to preliminary trials of new interventions. Concerns have also been voiced about the requirement to disclose certain items, such as the scientific title of the study, the name of the treatment being tested and the outcomes expected from the study, at the time of registration.
The planned Registry Platform will not be a register itself, but will provide a set of standards for all registers. Not only has it standardized what must be reported to register a trial but it is creating a global trial identification system that will confer a unique reference number on every qualified trial.
The Registry Platform seeks to bring participating registers together in a global network to provide a single point of access to the information stored in them. Presently although there are several hundred registers of clinical trials around the world there is very little coordination among them.
Later this year, the WHO Registry Platform will launch a web-based search portal where patients, doctors, scientists and anyone else who is interested can search among participating registers for clinical trials completed or taking place throughout the world.
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Title: New trial registration standards
Author: Sue Knights
Article Id: 336
Date Added: 19th May 2006