Int’l Registration of Clinical Research WHO
Tue, 6 Apr 2004
On April 3, the World Health Organization (WHO) and Current Controlled Trials, Ltd (based in London, Philadelphia and Tokyo) announced that all randomized controlled clinical trials approved by the WHO ethics committee will be registered in a unique international registry of research. Such trials will be assigned a unique identification number so that scientists will be able to keep track of the results–including unpublished, negative results.
Currently, it is difficult to find unbiased results of clinical trials, or information about the safety of human subjects. The lack of a registry has led to unnecessary duplication, preventable harm, and wasted resources. Needless confusion reigns because several trials may have the same title, one trial may be reported in several places under different titles, and because many unsuccessful–even harm producing– trials are never reported at all. Thus, such trials are duplicated with the same adverse results.
The purpose of the WHO registry is to facilitate openness and to bring order to the chaos of clinical trials, by providing the means for keeping the international medical community informed about important health care findings through free internet access to information.
It is hoped that this international registry may provide Congress with a model for a congressionally mandated US registry of clinical trials, to monitor and keep track of all clinical trials that are under the jurisdiction of either the FDA or a federal agency. Clinical trials that are funded by the government, or are conducted at institutions that receive government funds, or are conducted for the purpose of obtaining a government license (FDA approval), should be required to be registered. The informed consent documents should be posted, adverse events suffered by human subjects should be posted, and the findings of the trials–whether positive or negative should be disclosed.
The need for a registry is needed to break the iron wall of secrecy surrounding clinical trials. Secrecy that has resulted in preventable fatalities, and “me too” drugs in contrast to genuine medical breakthroughs. The FDA has itself been caught keeping secret vital information about the hazards posed by drugs approved by the agency
See, for example: Antidepressant Makers Withhold Data on Children by Shankar Vedantam, THE WASHINGTON POST, Jan 28, 2003.
FDA Mum On Suicidal Side Effects? Sharyl Attkisson CBS evening News, March 30, 2004
A Dose of Denial By Kevin Sack and Alicia Mundy, THE LOS ANGELES TIMES, March 28 2004.
A Prescription for Peril, Editorial, THE LOS ANGELES TIMES March 30, 2004
Contact: Vera Hassner Sharav
International coordination of clinical research WHO
03 Apr 2004
The World Health Organization (WHO) and Current Controlled Trials (CCT) have announced that, from today, all randomized controlled trials approved by the WHO ethics review board will be assigned an International Standard Randomised Controlled Trial Number (ISRCTN).1 As a result, the scientific community should now find it easier to keep up-to-date with current research.
Randomised controlled trials are considered the best way to compare – in an unbiased manner – the effects of particular interventions on people or populations either for health promotion, prevention, treatment or for rehabilitation.
They are one of the main sources of medical knowledge, yet information about these trials is difficult to find. This is because several trials may have the same title, one trial may be reported in several places under different titles, and many trials are never reported at all.
Information is even more difficult to find about neglected diseases that disproportionately affect poor and marginalized populations.
WHO supports and funds much of the research in this area. However so far, there has been no mechanism to make the information generated from this research easily available to researchers, particularly those in developing countries whom it affects most. By providing free access on the internet, ISRCTNs offer a way to keep the international community informed about these clinical trials.
Supporting systematic trial registration is consistent with WHO’s commitment to increase knowledge sharing, access and utilization in low and middle income countries. According to Dr. Tikki Pang, Director of the Department of Research Policy and Cooperation, who is leading the effort in trial registration, “The ISRCTN Register is an important first step within a wider context of the new emphasis on the need to increase international access to and utilization of health-related knowledge”.
In the first phase, all trials included in the HRP (UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction) trials register have now been included in the ISRCTN Register. “Our trials register has been operational for two years and we welcome this opportunity to make our research programme in sexual and reproductive health more accessible to the wider community,” says Dr Paul Van Look, Director of Reproductive Health and Research at WHO.
Randomised trials in the other major research areas that the WHO supports – infectious diseases, childhood diseases, vaccines and others will be added shortly to the ISRCTN Register.
The ISRCTN Register also tackles the problem of publication bias – trials that are not published either because of negative findings, or language barriers, or inaccessibility of the researcher to journals. By registering clinical trials at the start of the research, the ISRCTN Register will ensure that this information is now more easily available.
“Although trial registration is an important step on its own, it should not be seen as an end in itself,” says Dr. Timothy Evans, Assistant Director-General of the Evidence and Information for Policy cluster of the WHO. “Only when these registers are efficiently used can they serve the purpose they are set up for. As an international agency with a mandate to set standards and norms, WHO will take steps to encourage its Member States to support the publication of research conducted within their countries and encourage the use of such registers.”
Working across 192 countries, one of the major challenges for WHO is coordinating national research activity in the global effort to reduce maternal mortality and stem pandemics like HIV, re-emergence of tuberculosis and malaria, and eradication of polio.
“We are delighted that the WHO are taking a lead in the registration of trials with an ISRCTN,” says CCT’s Managing Director Anne Greenwood. “The ISRCTN scheme was conceived to address the confusion experienced by the research community. For controlled trials to be useful on a global scale, it is critical that research be coordinated. ISRCTNs offer a way to do exactly that.”
The ISRCTN Register represents the first online service that provides unique numbers to randomised controlled trials in all areas of health care and from all countries around the world. Access to the ISRCTN Register is completely free and open to the public. Since its launch in May 2003, the Register has assigned ISRCTNs to over 1800 trials, and is growing fast.
The ISRCTN Register has been developed by Current Controlled Trials Ltd, part of the Current Science Group of companies. The Group has its headquarters in London, UK and also has offices in Philadelphia and Tokyo.
1 This is a unique number that provides a means of identifying and unambiguously tracking a trial throughout its life cycle. Information about trials that have received this number can be obtained from an online register maintained by Current Controlled TrialsR. Access to this Register is free of charge.
– Current Controlled Trials Ltd http://www.controlled-trials.com
For more information contact:
Dr Tikki Pang – Director
WHO/Research Policy and Cooperation
Telephone: +41 22 791 2786
Dr Abha Saxena
WHO/Research Policy and Cooperation
Telephone: +41 22 791 2406
Ahmet M. Gulmezoglu
WHO/Reproductive Health and Research
Telephone: +41 22 791 3417
Anne Greenwood – Managing Director
Current Controlled Trials Ltd
Telephone: +44 0 20 7323 0323