Research Personality: Tan Sri Dato’ Seri Dr. Robaayah Zambahari
Spearheading IJN into a world class cardiology centre
Malaysia’s premier heart centre, the National Heart Institute or most commonly referred to as Institute Jantung Negara (IJN), receives cardiology cases referred from all over the country and abroad. Since its establishment in 1992, IJN has kept abreast with the latest medical advances and remains the leading heart-related medical institution in the region. Part of IJN’s success is derived from the numerous multi-centre international clinical trials that are conducted there, many of which positively impact the clinical practice of medical professionals.
At the heart of IJN is Tan Sri Dato’ Seri Dr. Robaayah Zambahari, its Chief Executive Officer and Managing Director, and a Senior Consultant Cardiologist. Tan Sri Dr. Robaayah believes that she has one of the best jobs in the industry – pursuing research, performing life-saving operations, and shepherding IJN as the leading heart centre in the region. Following are excerpts of the interview with her.
Could you tell us what was the first clinical trial that you conducted?
That would be the ACUTE II (Antithrombotic combination using tirofiban and enoxaparin) trial which was published in the American Heart Journal 2002. It was tough as we had to juggle between conducting our first ever trial and clinical practice. We started recruiting patients in 1997 and I could vividly remember Dato’ Dr. Rosli Mohd Ali and Datuk Dr. Razali Omar as co-investigators and Ramayee as the study coordinator. Along the way, we learned the processes involved in clinical trials. There were 525 patients and 54 participating study sites. Our peak of excitement and satisfaction came when our manuscript was accepted by the American Heart Journal and seeing our names and institution in print – even though it only appeared in the Appendix! But that set the precedent for many more similar trials involving cardiovascular drugs and devices, particularly stents.
What would you consider to be your biggest research achievement?
While it is difficult to say what was the ‘biggest’ research achievement, I consider two types of trials as particularly ‘special’. The first type of trial is one that had a major impact in clinical practice. For example, the PLATO Study which investigated ticagrelor versus clopidogrel in patients with high-risk acute coronary syndromes. This study found that ticagrelor significantly reduced the rate of death from vascular causes, myocardial infarction or stroke as compared with clopidogrel.
The second type of trial is one where we conducted a first-in-man trial. For example the REMEDEE Study which demonstrated the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting Stent compared to the commercially available TAXUS® Liberté® Paclitaxe-Eluting Stent in the treatment of single de novo native coronary artery lesions.
How do you lead and motivate your research team?
We have a strong research team with a clinician as director, a senior manager and a number of clinical research assistants (CRAs). We take the effort to keep in constant communication, encourage and guide the CRAs on the ways to conduct and lead research projects (be it an investigator-initiated trial, an industry-sponsored trial or in collaboration with higher education centres and pharmaceutical companies). My team and I have also gone the extra mile to create a conducive ecosystem to support research activities; this include ensuring a well-trained study coordinator to oversee the division of work amongst the CRAs, to facilitate data collection, data processing and activities throughout the study period. Finally, I believe that every individual’s contribution to the research project and to the team should be acknowledged as it serves as part of the motivational process.
How do you ensure that your clinical trials are of high quality and run smoothly?
We make sure that all equipment necessary for the study are available and well-maintained in accordance with national and international guidelines. For research projects that require funding (especially investigator-initiated trials), research funds can be applied from the Institut Jantung Negara Foundation (IJNF) as well as from special grants from the government. Equally important is for the research team to follow basic training in Good Clinical Practice (GCP), attend regular on-going training with didactic lectures and workshops. The research team are also given opportunities to attend local and regional conferences and workshops that are related to the proper conduct of research projects.
I have one of the best jobs in the industry – pursuing research, performing life-saving operations, and shepherding IJN as the leading heart centre in the region
How has the research culture evolved in IJN over the past decade?
Clinicians and allied health personnel have become more aware of the importance and significance of conducting research in the clinical field, to help answer hypothetical clinical questions, to look at clinical trial data critically and meaningfully, to understand the limitations of the trial results and to apply the results accordingly for the safety and benefit of patients.
IJN established the Clinical Research Department in 2004 to support clinicians and allied health personnel in conducting research projects. The Institutional Ethics Committee was also established to ensure all research projects conducted here comply with the International Conference on Harmonization-Good Clinical Practice ICH-GCP to ensure that the well-being of trial subjects are protected.
To ensure that the relevant staff who are involved in research projects are well-trained, IJN has conducted in-house GCP workshops since 2008. This in-house GCP workshop is a collaborative effort by IJN and Cyberjaya University College of Medical Sciences (CUCMS), and is conducted by an established researcher, Prof Dr. Abdul Rashid Rahman.
How has clinical research improved the function and services of IJN?
I believe that participation has improved our knowledge on the conduct, interpretation and the limitations of clinical trials. As such, we are able to apply best practice in the day to day management of our patients. By participating in clinical trials involving devices and technology, we are able to get first-hand experience in understanding the safety and efficacy of these products, again empowering us to apply our knowledge in managing our patients. Besides, earnings from clinical research projects can be utilized as study grants to encourage clinicians to embark on in-house research projects, which can lead to improvement in the treatment of our patients.
What would be your advice to aspiring clinical trial researchers?
Fundamentally to be a good clinician today, we need to practice evidence-based medicine. To do so, we need to keep abreast with the latest scientific knowledge and progress relevant to our field with a view towards improving patient care and outcome.
The most practical way to start one’s career in clinical research is to be part of a research project team – to learn from a senior mentor i.e. the principal investigator of the project on the various aspects of a clinical trial – formulating research question, study design, preparation of protocol and submission for grant application, understanding issues related to ethics and regulatory principles that govern trials in human subjects, practical operational matters such as recruitment of subjects, data collection and analysis, managing finances and personnel in the research team, and finally preparation of materials and manuscript for presentation or publication.
Apart from this practical ‘apprenticeship’ in clinical research, the aspiring researcher needs to equip himself/herself with the relevant knowledge on the principles of clinical research and trials, bio-statistics as well as ethics and research management by attending formal courses on research methodology, bio-statistics and obtaining GCP certification.
IJN successfully implants smallest pacemaker device in patients The National Heart Institute (IJN) has successfully implanted four of the world’s smallest pacemaker device, the Medtronic MICRA Transcatheter Pacing System (TPS), in patients suffering from bradycardia (slow or irregular hearbeat). Its senior consultant cardiologist and electro physiologist, Datuk Dr. Razali Omar said this was done after IJN was chosen as the first centre in Asia Pacific to participate with Medtronic Inc., the world’s largest maker of medical devices’ global clinical study. The MICRA TPS is one-tenth of the size of a conventional pacemaker, and comparable in size to a large vitamin.
Source: ABN News (March 2014)
Facts
Since the inception of IJN in 1992 to the end of 2013, more than 2.6 million outpatient and 238,453 inpatient visits were recorded. During the same period, 146,031 invasive procedures and 59,674 surgeries have been performed, and this included cases of paediatric congenital heart diseases.
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