Research Personality: Dato’ Dr. Chang Kian Meng

Dato’ Dr. Chang Kian Meng Head of Department and Consultant Haematologist at Ampang Hospital, Selangor D.E. Chairman of the Medical Research Ethics Committee (MREC) National Advisor of Clinical Haematology Services, Ministry of Health Malaysia
Dato’ Dr. Chang Kian Meng is an acknowledged expert in Haematologic Malignancies and in Stem Cell and Bone Marrow transplants. He is currently the Head of the Haematology Department and a Consultant Haematologist at Ampang Hospital, Selangor. He graduated with an MBBS from the University of Malaya before obtaining MRCP (UK), FRCP (London) and FRCPA (Haem) between 1992 and 2011. He concurrently holds the posts of National Advisor of Clinical Haematology Services and Chairman of the Medical Research Ethics Committee (MREC), Ministry of Health Malaysia.
Dato’ Dr. Chang was the past President of the Malaysian Society of Haematology from 2010 to 2013 and continues to be a member of the National Stem Cell Research and Therapy Committee and a member of the Malaysian Society of Transplantation. He has been the Principal Investigator and a Co-investigator in more than 30 multi-centre and multi-national clinical trials and has successfully published over 40 articles in international peer-reviewed journals.
Dato’ Dr. Chang recently shared with CRM some of his experiences and insights as a clinician researcher.
Dato’, you are currently undertaking several important and leading roles within the hospital and Ministry of Health. How do you still stay active in research and why do you feel it is important to do so?
In the past, I have served as a Principal Investigator for industry-sponsored research (ISR). However, because of my commitments to the MREC, I now mostly undertake the role of a Co-investigator and thus I am still able to stay very much active in clinical research, particularly in investigator initiated research (IIR) whereby I collaborate with teaching institutions to collate data. I believe that it is important for clinicians to design and conduct their own clinical trials to address the health concerns of our region.

Dato’ Dr. Chang with Dr. Damenthi & team from CRC Hospital Ampang
Can you share with us some of your research which have been published in top tier journals?
One would be on Hepatitis B Virus Reactivation in B Cell Lymphoma Patients Treated with Rituximab which was published in the European Journal of Cancer. Another would be the Haematological Reference Intervals in a Multi-ethnic Population as well as Polymorphisms in Methylenetetrahydrofolate Reductase Gene and Risk of Non-Hodgkin’s Lymphoma in Multi-ethnic Population, published in PLoS One and the Journal of Human Genetics respectively.
What do you see are the challenges that arise when you engage in clinical research?
Firstly, as clinicians, we work in an environment whereby healthcare service is the main thrust. However, when the focus was shifted to driving a research culture among clinicians, clinical research became an added responsibility. I am saying this because research requires its own infrastructure and support staff; but within a hospital setting the laboratory, wards, clinics and healthcare personnel are put in place primarily for clinical service. Thus, we have to take it upon ourselves and rely on our own motivation and commitment to drive an initiative to carry out research. Most often than not, promotion in the government hospitals are mostly based on clinical service output and seniority.

Transplant ward at Hospital Ampang
Do you think it will be a good move to have “protected time” to enable clinicians to conduct research?
If there are sufficient number of doctors in the service, it would be worth considering. But this has never happened over my career for the last 28 years. Perhaps the only way is to make clinical research as a private entity and making it happen in a more structured fashion. This means that clinicians can take an unpaid day off from their official duties to conduct clinical research. It definitely is an uphill battle to get clinicians to do trials in terms of finding time and resources.
Can you briefly describe when you first began conducting trials and how did it go?
I started conducting clinical trials in the late 90’s. The first ISR trial was on patients with Chronic Myeloid Leukaemia using Nilotinib. During that time, it was a one-man show. In 2006, when I became the Head of Department, I placed a nurse to solely collect data for clinical trials. Although this was met with disapproval from the Nursing department, I was adamant with my decision as I believe that if you want to do something well, there must be a person carrying out that job full time.

Transplant ward at Hospital Ampang
From your experience, what is a common problem that trials in Malaysia face?
Well, in most hospitals we don’t have a patient registry. At the end of the day, the clinicians have to estimate the number of patients that they see. More often than not, when clinicians look at the inclusion and exclusion criteria of a trial, they tend to omit the fact that out of the total number of patients that they see, one third will refuse to join the trial, one third will have logistical issues and only one third will give their consent. In Ampang Hospital, we are fortunate to have our own haematology registry, enabling clinicians to give a more accurate projection of the number of patients with certain conditions that we can roughly provide for a trial. At the end of the day, we never promise you what we can’t deliver. Thus, I cannot emphasise enough the importance of patient registries at hospitals to tackle patient recruitment issues. If I may add, the scenario here in Malaysia is different from that in the United States. In Malaysia, our healthcare is paid for by the government. Whereas in the U.S., patients without insurance coverage would either have to fork out money from their own pocket or enter a trial in order to receive treatment. In Malaysia, regardless of a patient consenting to participate in a trial, he or she would just need to pay a minimal fee to receive treatment. This may be another reason why patients do not feel it necessary to participate in a trial. Changing the mind-set of patients to participate in a trial for the purpose of contributing to the betterment of healthcare requires time and continued public awareness.
There are patients who may feel that by participating in a clinical trial, they are being used as guinea pigs. So, how do you go about explaining and alleviating their fears?
It is the clinician’s role to convince the patients that the trials are very well monitored and that they are being treated by a group of people who are experts in that field. It is important to educate them that the trial will at no time jeopardise their outcome or survival. This goes to say that at any point in time when a patient has adverse side effects, the treatment will be ceased or if patients want to withdraw from the study, they can do so at any time. The responsibility rests on the clinician to reassure their patients that trials are conducted in a regulated environment and that they won’t be harmed. Equally crucial is for the patients themselves to have the mind-set that they are participating in a trial because they want to contribute to the research question.

Nurses station at Haematology ward at Hospital Ampang
As MREC Chairman, what do you see are the common issues that delay the approval process of a trial?
I feel that the website of the National Medical Research Register (NMRR) has too many procedures and steps, thus making it complicated especially for first-timers who are using it. As a matter of fact, these first timers, especially those conducting IIRs, spend 4 to 6 months just to complete an online submission. In the West, I know of private ethics committees that can give approval in a week. These ethics committees are privatised and have a quorum of 5 members. Reviewing and commenting on the proposed trial by these members are done online and submitted to an external private company who will then send it to the contract research organisation (CRO). However, if you were to rely on government agencies whereby its members have their full time clinical practice and are contributing to the ethics approval process on a voluntary basis, it invariably will take longer. For MREC, 6 to 8 weeks is the standard approval timeline.
Finally, how has conducting trials changed the way you manage patient care?
In clinical care, there is a certain degree of subjectivity to the way we diagnose and treat patients, banking on how much experience a clinician has. In contrast, clinical trials happen in a more regulated environment and is very much evidence-based. Clinical trials have been a good training ground for me and I now handle adverse reactions in a different approach. For example, when I administer a certain drug, I make sure that it is because of that particular drug rather than assessing it subjectively. As far as haematology trials are concerned, it provides an alternative option to patients who are refractory to the current medication or not going into remission. This was actually the first reason why I wanted to do clinical trials – to provide access of new or expensive drugs to patients.
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