Dr Sri Wahyu Taher is currently the Consultant Family Medicine Specialist and Head of Clinic, Klinik Kesihatan (KK) Simpang Kuala Alor Setar, Kedah. She is also the Head of CRC Unit KK Simpang Kuala which is one of the research unit in primary care clinic in the state of Kedah.
Dr Sri Wahyu Taher attained her BSc Medical Science from St. Andrews University Scotland in 1988. She proceeded with MBChB from Glasgow University Scotland in 1991. She returned to Malaysia in 1993 to work in Hospital Alor Setar and obtained her Masters in Family Medicine UKM in the year 2000. She had 2 years of experience working in Scotland. She then continued with subspecialty training in Non-Communicable Disease Management Primary Care from Monash University Victoria Australia in 2006. The fellowship training was an eye opener and upon returning to Malaysia in 2007 she started to get involved with ISR in 2008.
She holds many important posts and responsibilities in the Ministry of Health Malaysia and with her long history of service she has received numerous awards for excellence of service.
She is currently the Vice President of Family Medicine Specialists Association Malaysia and Chairman for Hospice Kedah Association, with a passion in palliative care.
Dr Sri Wahyu Taher is Principal Investigator for 11 ISRs and Co-Investigator of a few. Other than ISR she is active in Investigator Initiated Research (IIR) in collaboration with public and private universities. To date, she has had 26 publications. Many of the multi centre ISRs have been made published by sponsors and various authorities.
- What first sparked your interest in clinical research
I started taking up observational research in 2008 after I came back from my fellowship training. During the training I realized research is a very important element in order to develop the fraternity. The people whom I worked with in Monash were always doing research and it was part of their work culture. By doing research, we make known of our work and effort in specific disciplines and when it gets published, other’s would learn from it to improve their outcome. This chain of knowledge transfer and continuity of care has made research a unique entity of medical advancement. The awareness on how important it is to do research has made me determined to start conductnig research in primary care clinic. I am very fortunate because family medicine has a wide scope of speciality and I can do almost any research of interest pertaining to primary care. Thus I have been involved in research on diabetes mellitus, hypertension, antenatal care and perinatal infant outcome, Ramadan fasting, bronchial asthma, vaccine and others.
When I started in 2008, there were no medical officers who were GCP trained and I started doing research from scratch. So I had to do the research all by myself. Gradually medical officers and nurses were sent for GCP training and we formed a research team. However in view of the lack in staffing, the nurse study coordinator later on was not able to help the team in conducting ISR. But we continued with whatever limited capacity accessible to us. Fortunately in 2017, CRM has decided to post a study coordinator on regular basis to help me with ISR at CRC KK Simpang Kuala.
- How has a clinical trial change your practice and management of patient care?
Research has trained me to be meticulous, strong in principles, abiding to the protocols rules and regulations. It makes me a responsible person especially when it comes to patient care. I am kept abreast with new technology, treatment management and global updates. It gives me the sense of belonging and in touch with other people in different countries involved in the same trial. Clinical trials made me realized the importance of accurate and complete documentation thus I have been practicing good record keeping in patients’ care. At the same time, I have trained my subordinates to practice good documentation.
- Why should doctors, particularly those in Health Clinics participate in clinical trials?
It is pertinent for doctors especially in primary care to do research. Research takes us through a set of principles and protocols that is unique to the trials. It is bounded by rules and regulations that are applicable to international standard settings and GCP compliance. Thus by doing research, doctors learn how to conduct proper research on patients according to the protocol. They are given opportunity to use drugs or devices that are not yet in the market. Patients are given opportunity to use the new technology which are sometimes unaffordable and inaccessible to them. Doctors learn of a new drug or device characteristics which then make them better and informed clinicians.
Doctors in primary care clinics see hundreds of patients every day and the number is escalating each day. They see a variety of cases presenting at the community they serve. Clinical trials in primary care represent the true disease burden and based on the conclusions derived from the trials, a lot can be done to change the disease pattern and risk factors.
Involvement of primary care doctors in clinical trials will definitely help to answer some questions pertaining to primary care management and hopefully enable to halt disease progression and its complication.
In addition to the above, doctors learn study design, appropriate statistical analysis and how to interpret results. This exposure will enrich the doctors and will help them to make decisions on the best treatment for the patients and not get swayed with promotional advocacies by pharmaceutical companies.
- Recruitment and retention of patients in clinical trials are known to be one of the most challenging aspects for investigators. How do you ensure successful recruitment and retention of patients in your trial?
I am privilege to be practicing in primary care clinic where rapport is an essential aspect of care. Patients have been coming to the clinic for quite a number of years and becoming very familiar with the system, surrounding and the medical staffs. It allows us to communicate with patients better and clinical trials strengthens the relationship because patients feel they are given priority and privilege. With good rapport and communication skills, patients have a sense of belonging to the clinic and relate to the clinical trial team issues pertaining to trials and others. They always know who to turn to relay their problems that can be a potential barrier to trials. At primary care clinics we treat the patients with utmost respect and priority and patients feel they are very important by all levels of health care professionals
- In your opinion, how has clinical research in Health Clinics evolved over the past decade
Before I started in year 2004, clinical trials in primary care clinics were almost impossible. I must have been one of the first to conduct clinical trials at primary care clinics. At that time clinical research organizations and sponsors were not convinced primary care clinics can conduct trials. When I received my GCP certification in 2004, a CRA approached me and I accepted the responsibility. Although it was a simple observational study, it was a starting point for me that have set a strong foundation for future trials. Subsequently I have been invited to be involved in many other clinical trials. To date I have conducted 11 ISR and 4 IIR.
Year 2013 was the year where there was a huge paradigm shift among the family medicine specialists (FMS) in Malaysia. The interest and awareness in building up primary care clinics into clinical research sites grew rapidly among family medicine specialists. Thus many of them took up GCP training and made changes to their clinics in preparation for upcoming clinical research. The recognition of how pertinent it is to do clinical research in primary care clinics have made the family medicine fraternity grow into a unique and diverse fraternity over the years. The development was made possible with the support of Clinical Research Centre Ministry of Health Malaysia and Clinical Research Malaysia (CRM). CRC MOH and CRM have supported family medicine specialists in terms of training and infrastructure, thus facilitating development of clinical research sites in many parts of Malaysia.
My involvement in clinical research have encouraged many other family medicine specialists to actively start conducting research and to change the mind set of others who thinks that clinical research is not feasible in primary care. I have proven to others that clinical research in primary care clinics are possible and cost effective. Now, many primary care clinics are equipped with reasonable infrastructure suitable for clinical research and many family medicine specialists are doing clinical research of various topics and scopes.
This development is in tandem with the aspiration of our Director General of Health who wants to put Malaysia at par with other developed countries in clinical research, if not the best in South East Asia.
- What one word best describes your career as a clinical researcher / investigator? Why?
It is simply empowering.
By doing research, I learn to become a person with strong principles and I have brought these principles down to my subordinates in order to improve service. For example, in research, clear documentation is essential and thus I have instilled this principle onto my subordinates to enable them to uplift the quality in patient care.
Research has also empowered me to diagnose accurately and have set a high standard of care for myself when treating patients. I do not simply brush off a complaint by my patient in research setting for I need to report all adverse events to the sponsors and ethics committee. Thus in clinical setting, I have learnt to be meticulous in caring for my patient and I listen to them attentively.
By taking up research I learn to become a competent leader, leading my team into the correct direction, motivating them all the time, training and guiding the team members when it is needed. By doing so, I have then empowered my team members to become independent individuals working in a team with a common and focused objective.
- Where do you see yourself in the next 5 years in the clinical research industry?
I will want to continue to do clinical research in the next 5 years expanding from phase 3 and 4 to phase 2 and perhaps given the opportunity phase 1 clinical trials. In addition to this, I would like to expand my scope of research to more wider scopes (eg. vaccine, adolescents, dermatology and elderly care) and for more clinical research collaboration with universities and other agencies.
Other than focusing in doing clinical research alone, I would like to expand my expertise into clinical research training thus making CRC KK Simpang Kuala a centre of research training in primary care. However this can only be achieved if I have a dedicated research team and I hope this vision can materialize in the very near future.
Of course I would like to see clinical research centre KK Simpang Kuala expand in its size and function to a more diverse unit, improved facilities and increased in staffing. I aspire CRC KK Simpang Kuala to become the centre of clinical research excellence in primary care in Malaysia if not in the northern region of Malaysia.
What changes would you like to see being made by the policy makers to create a more conducive ecosystem for the conduct of clinical trials in Malaysia?
There are many things the policy makers can do to achieve a conducive ecosystem for the conduct of clinical trials in Malaysia. For sure we need a lot of support from various policy makers and stakeholders. Firstly primary care clinics must form a clinical research centre or at least conduct trials without being halted by their superior and this should be made a directive from the higher level of authority.
Currently there is a lot of hindrance to clinical trials being conducted in primary care clinics simply because there is not enough staffing to support the trial. Thus policy makers need to allocate posts at health clinics in order to form a dedicated team to conduct clinical trials. Posts must be for all levels of health care professionals.
Financial support is essential and it has to be made adequate for infrastructure, equipment and other facilities rendered vital for clinical research. There should also be enough support from policy makers for ongoing training and upgrading of clinical trial site.
Policy makers must allow collaborative work in clinical trials between primary care clinics and other agencies example hospitals, private agencies, private hospitals, universities and others.
For early exposure to clinical trials, the university academician must start exposing the students early by incorporating clinical research into the curriculum. This can be implemented at undergraduate or postgraduate level.
CROs are given more opportunity to conduct trials in Malaysia. Policy makers must take steps to make Malaysia more attractive for clinical trials.
Finally, CRM can support clinical trials in primary care as an advocacy to enhance the collaboration with various policy makers.