Drug companies compelled to come clean over clinical trialsMay 25, 2006 | www.outsourcing-pharma.com
The World Health Organization (WHO) has announced details of a new initiative compelling drug companies to register all clinical trials on humans after public pressure for more transparency.
The initiative will take the form of an International Clinical Trials Registry Platform, and is aimed at standardising the way information on medical studies is made available to the public.
The new Platform will not be a register itself, but will provide a set of standards that all clinical trial registers around the world should adhere to, including 20 key details that should be disclosed at the time studies are begun, such as the scientific title of the study, the name of the treatment being tested and the disease area being studied, as well as the expected outcomes and funding details.
Currently, there are several hundred registers of clinical trials around the world but little coordination among them. Later this year, the WHO Registry Platform will also launch a web-based search portal to provide a single point of access to the information stored in theses global databases so that scientists, patients, doctors etc. can search among participating registers for clinical trials taking place or completed throughout the world.
The initiative seeks to soothe the growing public demands for transparency regarding clinical trials after a spate of recent high-profile drug recalls, culminating in the dramatic withdrawal in 2004 of prescription painkiller Vioxx, after an independent retrospective study of the drug raised alarming cardiovascular safety concerns.
Vioxx had been available on the market for five years and was being used to treat millions of patients before these safety concerns finally led to its swift withdrawal. There have since been several allegations made by whistleblowers that the drug company covered up unfavourable clinical trial results, and that the practice may be rampant throughout the industry.
"Registration of all clinical trials and full disclosure of key information at the time of registration is fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants," said Dr Timothy Evans, assistant director-general of the WHO.
Although registration with the new WHO database will be voluntary, there have been a number of strong incentives put in place to force drug companies to comply.
Perhaps the key incentive is the cooperation of the International Committee of Medical Journal Editors, a group representing 11 prestigious medical journals, who introduced 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.
"The "Responsible Registrant" for a trial will be either the principal investigator (PI) or the primary sponsor, to be decided by an agreement between the parties," said a WHO statement. "However, the primary sponsor is ultimately accountable for ensuring that the trial is properly registered. For multi-center and multi-sponsor trials, it is the lead PI or lead sponsor who should take responsibility for registration."
The WHO is forging ahead with its plans despite strong resistance by many in the industry that believe the new requirements could jeopardize academic or commercial competitive advantage.
In response to these concerns, Dr Ida Sim, associate director for medical informatics at the University of California, San Francisco and coordinator of the registry platform initiative stated: "Our aim is to make clinical research transparent and enhance public trust in science, but we are engaged in a fair and open process with all stakeholders.”
“We look forward to continued dialogue about trial registration and results reporting as we move forward with the Registry Platform."