Dr Goh Pik Pin, director of the Clinical Research Centre (CRC), and Dr Salina Abd Aziz, consultant psychiatrist and chairperson, MOH Medical Research Ethics Committee, and head, CRC Hospital Kuala Lumpur, highlight the main improvements of the CRC as well as the clinical research environment in Malaysia since 2014. Dr Goh also takes the time to explain the next steps that are required to ensure the improvement of Malaysian healthcare and how clinical trials can help in this regard.
What have been the Clinical Research Centre (CRC)’s main achievements since our last meeting in 2014?
Since we last met, the Centre has grown in size and in the number of focus areas researched. We have expanded from 17 to 33 clinical research centres in large hospitals. Research has become more widespread, with an increased awareness of the importance of clinical research amongst all healthcare professionals. The six research institutions under the National Institute of Health, Ministry of Health will be working more closely when they move to one campus and will cover important research areas that will benefit the country. We also received increased research funding from the government especially for the population-based health and morbidity surveys and biomedical research. We have better equipped our research institute with new technology We are also using more advanced software, with a view to moving into big data, training our employees to better utilize such data. We also send staff for attachment to renounce research institute abroad so that they can learn from other experts and build their experience. Our emphasis is now on training and human capacity building.
We are working on Vision 2020, which is a goal to make Malaysia a developed country by 2020. Continuous development is stimulated by research. Our current research mainly revolves around new drug development and medical devices especially in areas where there is a gap in the current standard of therapy. We have done research in tropical diseases and published an article on Dengue fever and Malaria. Currently, we are looking into mathematical modelling of the outbreak of Rabies, and the interactions between dogs and humans. Finally, some of our doctors at CRC are investigating safety in the community, such as the use of seat belts in cars, drowning, and the causes of other unnecessary deaths.
In Malaysia, there is a lack of digitalization in health, and this can create difficulties acquiring the adequate information and data required. How is CRC surmounting this issue?
Together with our counterparts in the Ministry, we have developed “my health data warehouse”, where health services data, such as prescription information and patient discharge will be stored in My Health data warehouse. The other area of big data is a patient registry. There are few patient registries on important diseases that have been around for more than 10 years. They capture the patient’s outcome information. the outcome data can help determined prognostic factors such as genetic or lifestyle, food or cultural influence.
While the specifics of the new government’s plan remain opaque, what reforms would you like to see initiated that would support clinical research and improve healthcare?
First, I want to see an increase in the healthcare budget, particularly for activities that promote health and prevent diseases. With the rise in non-communicable diseases, it would also be beneficial to expand our investments into outreach and awareness campaigns. I also believe that the awareness campaign has to be more tailored to the younger generations, who will encounter these ailments in the future. They are what we call natives of the digital age, so the awareness campaigns need to be more electronic and interactive.
In terms of clinical trials, there needs to be an emphasis on obtaining informed consent, with patients having the right to say no to participating in a research. Some people have a misconception that participating in a clinical trial is like being experimented on, and such concern exists mainly among educated people. However, the opposite perception may occur in rural areas, where there is a tendency to overly trust the doctors and they too easily agree to participate in clinical trials. Thus, we must raise the awareness across educational and geographical boundaries so that our patients are mindful of the risks and benefits of joining a clinical trial. It also must be stressed that most research findings will benefit future patients. It may have adverse effects on those taking part, but in the long run will be beneficial to patients.
How would you assess the potential of Malaysia as a hub for clinical trials?
We have a wide demographic and genetical pool, which is important for the testing of new drugs, as it may have different effects on different genetic makeup. It may be difficult to find such diversity in European countries or in North America. In this regard, clinical trial done on the multi-ethnic population in Malaysia can point out the different responses to drugs based on genetic variation.
Commensurately, many drugs originate from plant extracts or biological organisms. As Malaysia has a diverse range of flora and fauna, we can initiate drug development, and one day be a hub for such pharmaceutical development. If we do not conduct research in-house, we will not be able to develop new technologies and medicines that come on the market. Drug development stakeholders will not be aware of the advancements if we do not have a strong research base in Malaysia
How important are partnerships for CRC?
Partnerships are imperative for our work. We are part of the medical network and we need to work with doctors to give them the necessary training and support. Moreover, we need staff that take on other roles such as data analysts, study coordinators and statisticians. The company Clinical Research Malaysia (CRM) assists us, sourcing the non-medical staff that are so important for the overall running of the trials. They also provide a mechanism to receive funding. As a government agency, CRC can’t receive money from private companies. Thus, CRM is registered as a private company to be able to receive industry funding and hire study coordinators to assist in clinical trials.
We also have industry partners such as IQVIA, who had many programs with us, including 11 prime sites, and we are working towards partner program. Similarly, we work closely with DNDI (Drugs for Neglected Disease Initiative), an NGO focused on neglected illnesses lacking market coverage, like hepatitis C. DNDI takes on the responsibility of providing investigational product and run the trials. We have an international initiative, discussing with DNDI and a pharmaceutical company to produce a new drug that is combined with an older hepatitis C drug and this combination has shown very good effectiveness in curing Hepatitis C. We are now in stage 2 of this study.
How involved is the government in clinical trials and CRC?
The government is a key player in clinical trials. The Prime Minister has invested resources into the vision 2020 plan. They have been investing in biological research and provide some operating budget to CRM. Without state funding, we cannot complete our work. The government delegates the awarding of research grants to the Ministry of Science and Technology. Unfortunately, they have a bias towards awarding funding to universities, as in some other countries, Universities are the ones to conduct the majority of the research. In Malaysia we are unique in that within the MOH, the staff also conduct research.
Our Prime Minister is also looking at attracting more partnerships and especially looking East towards Japan, Korea and China. CRM has signed Memorandum of Understanding with Zheijang University, China. India has been helpful in training too, and Singapore is working with our oncology network to train our oncologists in Singapore. Nonetheless, we welcome anyone who can bring a good study and good ethics to Malaysia.
What changes would you like to see to further improve the CRC hospital?
I would like to see more collaborative research. We have seen a lot of studies on drug intervention, but we should not conduct these in isolation. Clinicians should not only focus on providing drugs, but also on acting in wider public health. We must take a more holistic approach, considering every risk factor.
Moreover, we would like to increase patient involvement in the clinical trial process and raise the consideration for the patients and those being tested in the trials. We should not simply focus on whether the treatment keeps the patients alive, but how we can increase patients’ quality of life. In addition, I would like to see spirituality more incorporated into our clinical trials, not simply at the level of individual religion, but in terms of the meaning of life. Sometimes people will forego an extension of life for a more spiritual life, for example being able to pray every day as required rather than being asleep for most of the day due to the treatment. Thus, we must consider this as a factor.
What are the three main goals that you would like to achieve in the next five years?
Firstly, my goal is to have a strong successor plan across the network of CRC so that the retirement of senior staff at CRC Hospital does not create any disruptions in its function. My second goal is to train our best and brightest young people with scientific minds to conduct research I hope that in the future we will not have to conduct pre-clinical studies on animals, instead preclinical studies can be done in cultured cells at a laboratory,
Thirdly, we must remember that we are conducting research in a fragile natural biosphere. Global warming is a serious concern across the world due to rising sea levels and risks of droughts across the world. Our role as research scientists is to improve people’s lives. If we only research new drugs and therapies, ignoring research on the environment, our future will be catastrophic. Thus, researchers need to focus on new areas such as carbon emissions, food waste, and pollution to name a few. Hopefully, with advancements in technology, we can address these issues as well.
