Registration of prospective clinical trials is essential to prevent fraud and manipulation of data


 Intervention Health Research

Registration of prospective clinical trials is essential
to prevent fraud and manipulation of data

Medical Journal publishers can be a major player 
in enforcing compliance - Dr.Manju Rani 

KAULA LUMPUR (MALAYSIA): Prospective registration of all clinical trials is essential to prevent fraud and manipulation of data in intervention health research. International Clinical Trial Registry Platform (ICTRP) is a global initiative which aims to make information about all clinical trials involving human beings publicly available. Medical Journal publishers can play a vital role in enforcing compliance as regards registration of these trials. This was stated by Dr.Manju Rani Senior Technical Officer Health Research Policy at WHO Regional Office for Western Pacific Manila Philippines. She was making a presentation at the recently held APAME Congress 2012 at Kaula Lumpur Malaysia organized by Association of Malaysian Medical Journal Editors (AMMJE) in collaboration with WPRIM and University of Malaya.
Registration of these clinical trials, she further stated, should be in a web-based registry which is publicly accessible and searchable. The researchers are required to provide the key metadata at the time of registration. Publication bias has to be looked into because it is often influenced by the direction or strength of the trials results. It is also important to prevent selective reporting, incomplete reporting of trial outcomes associated with statistical significance. She then referred to the legal action taken against GSK recently for its alleged failure to disclose important safety and efficacy information concerning the use of its antidepressant preparation Paxil in North America.
There has been a major change in the place where now most of the trials are taking place. It is estimated that now almost 40%of clinical trials are conducted in Asia, Eastern Europe, Central and South America. Many countries in Asia like India and Malaysia are competing to attract investment in overseas companies as a means of economic development but many of these countries may not be ready to deal with this sudden boom in clinical trials. While developed countries Dr.Manju Rani opined, have strong regulatory infrastructure to regulate and monitor clinical trials, it may be something new to developing countries. It is felt that these clinical trials are not conducted in ethical manner. It is the responsibility of regulatory authorities to assess whether research proposals meet the ethical and other requirements besides oversight of research infrastructure in developing countries where it takes place. Many of these trials are even published in journals from the developed world.
Indian Council of Medical Research Dr.Manju Rani stated has reported that Research Ethics Committees are inadequately equipped to fulfill this task putting the safety and rights of research subjects at risk. There is a concern for lack of attention being paid to trials relevance for the research population, protection of vulnerable study population and transparency in registration authorities’ procedures. Scientific community in India was now calling for public disclosure of complete data for review to ensure independent evaluation. There are many other reasons why clinical trials should be registered which include increased participation, increase in efficiency of research process i.e. ethical review, contribution to systematic reviews, speedy access to results, enhanced transparency and accountability, increase in effectiveness of research funding, improve access to research information, improve equality and ownership and facilitating policy development.
Speaking about the aims of ICTRP she mentioned significant reduction in the gap between what we do and do not know about clinical trials particularly those conducted in developing couriers, more countries should establish their own clinical trial registries meeting WHO standards or ensuring that clinical trials are registered in a WHO Primary Registry which will help improve the quality of registered data. ICTRP is a country led initiative. The primary registries should meet specific criteria for contents, quality and validity, accessibility, unique identification, technical capacity, governance and administration. It should be managed by a not for profit agency and must have the government support within the country to act as the primary registry for the country or region. It must also meet the requirements of International Committee of Medical Journal Editors (ICMJE). At present Primary Registries have been established in Australia, New Zealand, Brazil, China, Korea, Germany, India, Cuba, Iran, Japan, Netherlands, Pan Africa and Sri Lanka. The volume of registered clinical trials is increasing. In China, 1453 clinical studies were registered of which 48% were sponsored by government foundations, 32% were self funded and 15% were funded by pharmaceutical industry. It included 562 prospective registrations. Approximately thirty to fifty thousand studies involving human being are published in Chinese Medical Journals but less than one percent of these studies were registered. It is time that all countries Dr.Manju Rani remarked, should make registration of clinical trials a legal or mandatory requirement.
Registration of clinical trials, Dr. Manju Rani further stated was a part of good research practice and it is also an ethical requirement. ICMJE guidelines mention registration a precondition of publication. It further states that member journals will require as a condition of consideration for publication registration in a public trials registry. Trials must be registered at or before the onset of patient enrolment. But journals in Asia, she said, were not enforcing this despite rapid increase in trials being conducted in Asia. APAME and other similar bodies of medical journal editors, she felt should adopt and endorse clinical trial registration as a precondition for publication and membership. She also referred to the Malaysia National Medical Register. Prospective registration of intervention research also includes observational studies to ensure accountability in health research and reduce misconduct, she added.

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