Sunday, October 28, 2007

Ministry sets up national register on clinical trials

Star: KUALA LUMPUR: The Health Ministry urged all clinical research centres in the country, including those in private hospitals and universities, to register their studies.
For this purpose, it has set up the National Medical Research Register (NMRR) that enables online registration (www.nmrr.gov.my), said director-general of Health Tan Sri Datuk Dr Ismail Merican.
Registration of their research on the NMRR helps ensure transparency and increases public trust and when fully implemented, would help reduce processing time, enable easy access, capture data on research and allow management to track progress, he said at the National Conference on Clinical Research on Friday.
A clinical trial or study is a type of research study that uses volunteers to test new methods of screening, prevention, diagnosis, or treatment of a disease.
Dr Ismail said that he signed the official circular on the New National Institutes of Health Guidelines where all research from the ministry research grants be registered, reviewed and approved by the appropriate authorities.
“If Malaysia is serious about becoming a clinical trials hub, medical research ethics must be given due attention by all stakeholders involved,” said Dr Ismail, whose speech was read out by the ministry’s Clinical Research Centre director Dr Lim Tech Onn.
Meanwhile a WHO official has suggested that Asean countries set up a regional registry on clinical trials in view of the growing number of multimillion dollar lawsuits over such trials.
The world organisation's director for Research Policy and Cooperation Dr Tikki Pang said six men suffered multiple organ failure following a clinical drugs trial in London while Nigerian authorities took a criminal case on top of a US$2bil lawsuit against a United States drug company for allegedly conducting a dangerous drug experiment on nearly 200 children for meningitis treatment.
While Malaysia wanted to capitalise on the growing market of clinical trials, many of the issues begged for transparency, Dr Pang said in his talk Clinical Trial Registration.
He said for a start there could be a National Ethics Review Committee that coordinated reviews done at individual institutions.
Dr Pang said that last year, WHO launched the International Clinical Trial Registry Platform (ICTRP) to promote the registration of all clinical trials worldwide and the reporting of a minimum set of results.
“This is to strengthen public trust in clinical trials by promoting transparency and accountability,” he added.

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