New human trial registration announced by WHO
in clinical trials by announcing new registration standards for all
medical research involving humans.
The move comes in the wake of the drugs trials at London's Northwick Park Hospital, which left six men seriously ill and left question marks over the regulatory process.
The World Health Organisation (WHO) is pushing for a change in current procedure, which allows scientists the option to disclose trial information at a much later stage of the research process.
The Geneva-based health body has recommended a 20-point list of details that should be disclosed in the registration of trials before they start.
The registration forms part of the International Clinical Trials Registry Platform, a major initiative aimed at standardising the way information on medical studies is made available to the public
High on the agenda is an effective response to growing public demands for transparency regarding all studies applying interventions to human participants, known as clinical trials.
March's drug trial fiasco, which left six volunteers facing hospital treatment for a severe reaction to the monoclonal antibody TGN1412, left several in a critical condition.
The disaster led to calls for an independent Inquiry into the conduct of the trial and the role the Medicines and Healthcare products Regulatory Agency (MHRA) came under intense scrutiny.
"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," said Timothy Evans, assistant director-General of the World Health Organisation.
The registration also goes as far as to provide access to drug trial registries run globally by companies, institutions and hospitals, through a new registry platform. The hope is the registry platform provides standardised framework for what has to be reported to register a trial.
Currently, there are several hundred registers of clinical trials around the world but little coordination among them adding to the complexity and confusion.
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.
"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," said Ida Sim, associate director for Medical Informatics at the University of California, San Francisco and coordinator of the Registry Platform initiative.
"We look forward to continued dialogue about trial registration and results reporting as we move forward with the Registry Platform."
Although registration is voluntary, there is a groundswell of policies aimed at spurring registration of all clinical trials.
However, some groups have raised concerns that these new requirements could jeopardise academic or commercial competitive advantage if they apply to preliminary trials of new interventions.
Similar concerns have 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.
Later this year, the >WHO Registry Platform will launch a web-based search portal where scientists, patients, doctors and anyone else who is interested can search among participating registers for clinical trials taking place or completed throughout the world.
