|
There are no translations available.
|
|
Malaysia’s National Medical Research Register (NMRR) complies with the WHO Trial Registration Data Set
National Medical Research Register (www.nmrr.gov.my)
Datuk Dr Teoh Siang Chin & Revathy U.Thandapani
Clinical Research Centre
|
|
|
|
In light of recent calls for registration and reporting of clinical trials, it was inevitable that Malaysia take a more serious look at procedures for research application. There was the need to have web-based systems to replace traditional paper-based processes. Undoubtedly, the National Medical Research Register (NMRR) is just one of a number of initiatives designed to make Malaysia a more favourable destination for clinical research outsourcing as Asia becomes increasingly attractive. In a 2007 study of global clinical trials registered with US-based Clinicaltrials.gov, Malaysia was listed among the top 50 countries with an average annual growth rate of more than 30 percent in the global share for biopharmaceutical clinical trial sites. With an estimated USD2 billion of the contract research outsourcing market heading towards Asia (Frost & Sullivan report Oct 2007), Malaysia needs investigators with mind-sets that sees clinical research as an opportunity to evaluate cutting-edge disease-prevention strategies and not be daunted by the obstacles.
|
|
|
It is a scientific, ethical and moral responsibility for all clinical trials to be publicly registered
WHO regards trial registration as the publication of an internationally-agreed set of information about the design, conduct and administration of clinical trials. These details are published on a publicly-accessible website managed by a registry conforming to WHO standards.
The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base. (http://www.who.int/ictrp/en/)
|
|
|
|
In Malaysia, medical research is seen as an effort of the Ministry of Health (MOH) to define the extent of national health problems and to find measures to control or eradicate them to meet the changing health needs of the country. Various policies and committees were put in place to ensure compliance with regulations and procedures with applications to conduct research submitted in hardcopy forms. In addition, research involving human subjects required prior review and approval by the MOH Research and Ethics Committee (MREC) with final approval of all research publications by the Director General of MOH.
In line with international best practices, the National Medical Research Register (NMRR) was initiated as an online registration process requiring clinical trials to be registered in publicly accessible research registers. As a web-based tool, the NMRR supports the National Institutes of Health (NIH) guidelines on research involving personnel, facilities or funds from MOH research grants. Registration on the NMRR ensures transparency and increases public trust in medical research. It also informs physicians and prospective volunteers about ongoing research they may wish to enroll, helps reduce processing time, enable easy access, captures data on research undertaken in the MOH, and allows management to track progress. In addition, passive information is compiled in a database as a Research Directory and an Investigator Directory.
Pilot tested since early 2007, the NMRR in being rolled-out to most of the 17 public hospitals nationwide under the Network of Clinical Research Centres as well as all six institutes under the NIH. Using the accessibility provided by the worldwide web, users are able to login anywhere and at anytime for online submission and have their study reviewed and approved by the appropriate authorities such NIH and MREC. As the NMRR is now linked to the National Pharmaceutical Control Bureau (NPCB) to notification of research registration in NMRR which is currently is voluntary. By extension on NPCB in future, the system further reduces paperwork, enables greater efficiency and speed up the process of review and approval for CTIL/CTX.
Officially endorsed by the Director General of Health on 5 Sept 2007, an invitation has been extended to researchers from universities and private hospitals to register their studies online via the NMRR. With clearer procedures and shorter timelines for both institutional and ethics to review and approve, when fully implemented the NMRR should encourage more medical research in Malaysia. In line with national aspiration to reach developed nation status 2020, the NMRR will propel the MOH to be at the forefront of all R&D efforts that will contribute towards advancing the heath care sector. |
|
|
| NMRR Website |
|
 |
|
| Since the Director General of Health’s circular on the registration of clinical trials on the NMRR in September 2007, there has been an exponential increase in the number of the investigators and clinical trials register. This online resource and register functions as a clinical trial registry that allows for greater transparency in the conduct of medical research in general and clinical trial in particular. Although still in its infancy, the evolution has been directed by functional needs and also based on feedback from the users. The NMRR has evolved into a more user friendly application that captures data on research, and allows means for oversight of clinical trials and to track progress of funded studies. In addition, the system also captures passive information that contributes to a Directory of Medical Research and a Directory of Clinical Investigator & Medical Researchers that will enable sponsors of clinical trials to identify suitably qualified clinical investigators to participate in their multi-centre trials. |
|
|
|
|
NMRR investigator and research registration Status report as at 31/07/2009
|
|
|
|
Table 1: Number of research registered on NMRR
|
 |
|
| Table 2: Distribution of research registered by Purpose of registration |
 |
 |
|
|
Table 3: Distribution of research registered by Research Type
|
|
 |
|
 |
|
 |
|
 |
|
