Doctors need certification to test new drugs on patients

NST: KUALA LUMPUR: Some doctors are testing new drugs on patients without getting Health Ministry certification.
Pleading ignorance would not save doctors from having to do so, said Universiti Kebangsaan Malaysia Hospital (HUKM) medical research and ethics committee chairman Prof Dr Raymond Azman Ali.
Some doctors who wanted to do clinical trials were not aware they had to undergo a three-day course on Clinical Practice Guidelines (GCP), banking on their qualifications instead, he added.
Dr Raymond said two cases were detected in HUKM this year and one in 2005.
"But the patients were okay. No one died and no side effects were reported. In fact, in one situation, a patient’s life was saved," he told the New Straits Times.
Life-saving trial or not, HUKM now wants all its doctors to obtain GCP certification.
Doctors who don’t have the certification will have to stop their research immediately and sit for the GCP course before they can conduct another.
"Sometimes, when doctors come with research proposals, they don’t even know what a GCP certification is.
"More often than not, doctors plead ignorance, saying they did not know they needed a GCP certificate.
"But they can’t plead ignorance in court," he said.
The Health Ministry made it a requirement for all those doing research involving humans to have GCP certification seven years ago to ensure patient safety at all phases of a clinical trial.
Ministry statistics show there are nearly 300 GCP-trained clinicians in the country.
Last year, HUKM approved an average of one research proposal a day. Of this, between 15 and 20 per cent went through clinical trials.
"Recognising the importance of research, the ministry and the university are trying to get all doctors who conduct trials certified," he said.
HUKM conducted trials in medicine, including cardiology, neurology, nephrology, diabetes, dermatology, obstetrics and gynaecology, paediatrics and cancer, he said.
Director-general of Health Tan Sri Dr Mohd Ismail Merican said the ministry introduced GCP training to make sure the rights of patients were protected and to make sure credible and authentic data was produced.