Materia Medica Malaysiana

April 23, 2007

Clinical trials in Malaysia

Filed under: Uncategorized — malaysianmedicine @ 10:03 am

Star Health: According to Director-General of Health Tan Sri Dr Ismail Merican, Malaysia would be a good place to host clinical trials.
WITH Asia being an emerging “power house” in pharmaceutical research and development (R&D), Malaysia wants in on the action when it comes to clinical trials, which plays an important role in the research of developing a new treatment.
However, the Health Ministry laments that Malaysia seems to be “ignored” with players preferring instead to go to countries like India, China, Thailand and Singapore.
Asia, after all has 80% of the 6.4 billion world population and Asean itself comprises more than 50 million people. “They seem to bypass Malaysia. The question is why,” said director-general Tan Sri Dr Ismail Merican.
“Maybe they do not know much about what we can offer. Or they know much about what we can offer but are saddled with problems like bureaucracy, delayed timelines or long approval processes.”
He said people were flocking to Asia because they wanted quality research besides cutting down on R&D cost.
And Dr Ismail, in a recent interview, listed many “good reasons” why Malaysia would be a good hub to host clinical trials.
Point number one, he said was the lower cost of doing clinical trials in Malaysia.
“We are good and cheap,” he said.
Clinical trials in Malaysia can be conducted in ministry establishments, private hospitals and medical teaching hospitals.
The recently launched network of clinical research centres (CRC) as a “one-stop-centre” for clinical trials to be carried out by the ministry was another indication of how serious the ministry took the matter.
The network will act as the main contact point where the 14 CRCs will facilitate access to the more than 50 general and district hospitals, and more than 100 health clinics as potential sites for clinical trials.
It is hoped that this could be further expanded to more sites in the future.
Phase I trials in Malaysia have improved from nil four years ago to seven in 2005, while Phase II trials were 11 in 2005 compared to two in 2003.
There were 96 Phase III trials in 2005 compared to more than 70 four years ago.
To reduce cost and shorten timelines, pharmaceutical companies are now outsourcing work to contract research organisations (CROs), who in turn were coming to Asia.
A report by Frost and Sullivan estimates that most of the world’s CROs are small niche players specialising in short-term projects while about 20 are large and global-reaching.
Another plus point is that Malaysia has a diverse genetic pool.
We are, he said, a multiethnic population, which would be tremendous for research, while Malaysia, he said, has a consistent record of achieving recruitment targets.
He went on to say that there was also strong government backing, where funding for research to the ministry under the Ninth Malaysia Plan was RM90mil.
In addition to this, the ministry’s infrastructure of having 14 clinical research centres (one in each state) and the future 9 Bio Sdn Bhd, which was the Institute of Natural Products, Vaccines and Biology, is good.
He was also quick to remind us that Malaysia has a strong regulatory framework where researchers have to have approved good clinical practise (GCP). Dr Ismail said that they underwent training and took examinations afterwards to get the certificate.
“This is so that the data generated from the trial will be of integrity and cannot be questioned by anyone,” he said.
Consequently, he said that the trained researchers would ensure the safety of human subjects where patients had the right to know issues such as their rights, why they were being enrolled, whether there would be any changes, alternative therapy and compensation.
“We have got dedicated staff and trained human capital to carry out the trials. We have trained more than 300,” he said.
One new venture set up by the ministry is the National Medical Research Register (NMRR), which is meant to help the industry and researchers identify good researchers who have a good track record.
He said that with the NMRR, eventually every clinical trial would need to be registered online. This would create a database that will give the pharmaceutical industry access to expert clinical researchers, the number of trials conducted and how many have been completed.
It is currently undergoing pilot testing by the Clinical Research Centre.
The networking of Malaysia’s research institutes with others such as the National Institute of Health in the United States is also a plus point.
“And the majority of our researchers speak comparatively good English,” he reminded.
Dr Ismail emphasised that not every trial was “simply” accepted but instead had to undergo a rigorous review, as it was necessary to ensure that all trials conducted were of high standards and patients were protected.
“Many may not realise the stringent monitoring and regular audits done by international regulators to ensure authentic data. They think we are just doing the trial, that all the person has to do is present to us. It is not that easy,” he said, adding that in any trial there were four “players”: the sponsor, monitor, investigator and ethics committee.
There were also lengthy procedures for obtaining approval, which include the Drug Control Authority and Medical Research Ethics Committee. In addition, there’s the need to comply with the International Committee on Harmonisation and Good Clinical Practice guidelines in areas such as recruiting trial sites and patients.
He said that six weeks was the average time taken for any organisation to obtain approval to carry out clinical trials in this country, provided they had all the necessary documentation.
Another reason for lack of interest in clinical trials, he cited was that patients in the developing world still had a measure of “fear and apprehension” because they did not know what such trials were all about.
“In developed countries, patients willingly participate in clinical trials because they view it as a means for researchers and pharmaceutical companies to develop new and improved therapies for human diseases,” he said.
“Many of them also volunteer to gain access to new experimental medications for their disease when all other treatments have been exhausted.”
So, he said it was important for clinicians who wanted to carry out research to give adequate information to the patients.
Among the issues being explored are the need to introduce new legislation or review existing ones to facilitate approval process, management of finances and protecting Intellectual Property rights, using ICT to increase efficiency in conducting clinical trials and create a database of clinical investigators and research done in Malaysia and need to have more awareness and education programmes.
Dr Ismail added that there was also a need to have specific human resource development strategies to build up a pool of experienced healthcare professionals who are trained and committed as clinical investigators and site coordinators.
“It is time to sit tight, look back and forward. And if we do not do anything about this, we will lose out,” he added.

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