Research Personality: Dr. Shanti Viswanathan
Dr. Shanthi Viswanathan obtained her MBBS from Kasturba Medical College, Manipal, India, before completing her MRCP from the Royal College of Physicians, Ireland. She subsequently pursued a one-year fellowship at the Queen Elizabeth Hospital, Birmingham and went on to obtain a fellowship in Neurology from the Ministry of Health, Malaysia. Dr. Shanthi currently serves as Honorary Lecturer and ad hoc examiner for undergraduates and postgraduates who are sitting for membership from the Royal College of Physicians of Ireland, and as Honorary Lecturer for University Teknologi MARA, Malaysia.
As a Consultant Neurologist at Kuala Lumpur Hospital, Dr. Shanthi has a keen interest in demyelinating diseases and movement disorders. She has been responsible for leading the establishment and development of the Demyelinating Diseases Registry, Demyelinating Diseases Clinic and Plasmapheresis Suite at the Department of Neurology, where she deals with the assessment of suitability of patients for disease modifying therapies and immunosuppressants
Dr. Shanthi combines her professional clinical duties with the role of Chairman in the task force for the development of the Clinical Practice Guideline (CPG) on the Management of Multiple Sclerosis in Malaysia, as
well as in the past has served as a Member of the development group for the CPG on Management of Dementia.
She is actively involved in various societies at the national and international level and has been part of the Malaysian team that won the “Tournament of Minds” at the World Neurology Congress in Bangkok in 2009. She has participated in a number of investigator initiated and industry sponsored drug trials, particularly in demyelinating diseases,dementia and epilepsy. Dr. Shanthi has published in various local and international peer review journals and given talks both locally and abroad on a number of neurology-related topics. She is currently involved in an ongoing research that looks at the role of Human Leukocyte Antigen (HLA) alleles in susceptibility of multiple sclerosis in Malaysia and various other investigator initiated projects on demyelinating diseases.
Dr. Shanthi recently shared her experience with Clinical Research Malaysia (CRM) on her research journey as a Principal Investigator.
Please share with us your experience in research.
My initial involvement in research focused more on Investigator Initiated Research (IIR) where most of the core work involved are non-interventional, observational and retrospective in nature. My long-standing interests are in movement disorders and demyelinating diseases, where I spend most of my time studying the latter and updating the registry which I have established in this Department in 2004. This registry has allowed me to develop various manuscripts and case reports which I have sent for publishing. As for Industry Sponsored Research (ISR), I make it a point to at least undertake one trial each year and so far have been involved in at least five trials since embarking on this research journey. Being involved in ISR has been fulfilling but not without its challenges.
Can you describe the challenges you encounter when conducting Industry Sponsored Research?
We all know that having a reliable study coordinator is crucial in any ISR studies and without one, conducting a trial can be a very time consuming for a Principal Investigator (PI). This goes without saying that a dedicated research team is required to ensure that trials are performed according to the protocol and applicable guidelines.
In addition, neurology-related trials that require intensive imaging or in particular biomarkers might be difficult to be carried out here due to the lack of specialized facilities in our centre. Also, obtaining cerebrospinal fluid may have its challenges by itself because of certain beliefs that exists with regards to lumbar puncture.
What are your major concerns when it comes to conducting a clinical trial?
I feel that it is of utmost importance to ensure that when study is closed, the subjects continue to receive the same drug that were given to them during the study period. Generally, most pharmaceutical companies anticipate that once the patients start responding to the investigational product (IP), the government will agree to bring in that drug into the country. However, while this may happen in other countries, it is not the case here.
At the end of the day, the benefits accrued to the patients should be the ultimate reason
for clinicians to get involved in clinical trials.– Dr. Shanthi Viswanathan
In Malaysia, patients are enrolled into these trials based on a very holistic and genuine need since there are currently no other treatment for certain neurological disorders. If at all we do not ensure the continuity of the IP in our subjects, they would have to return to their previous treatment, which is either ineffective or absent altogether.It is because of cases like these that I work very hard with the hospital’s pharmacy and Ministry of Health (MOH) to ensure that these patients continue to receive the IP that has shown promising results in treating their disorder.
When it comes to patient recruitment, what type of approach do you practice when enrolling them into a clinical trial
An open and honest communication with patients are necessary when explaining the objective, risks and benefits of the trial. In most cases, patients with neurological disorders such as multiple sclerosis are confined to only a few treatment options. Medications that are available are costly while those that have access to these may find them ineffective.Being in a trial provides accessibility to medications they otherwise would not have access to.
However, most of my patients have the fear of the unknown since an IP is a new drug that has not been tested, let alone marketed. It is my responsibility to reassure them that their safety is my utmost priority and that I will be with them at every step of the clinical trial process.
That being said, I also believe that patient enrollment is not just about achieving the target number of subjects in a trial but to address the patients’ needs and how they can benefit from the IP. It is also helpful to include the patients’ families and care givers into the discussion as it may help in ensuring that the patients obtain the necessary support and remain committed throughout the duration of the trial.
How has conducting clinical trials improve the way you manage your patients?
Conducting a clinical trial enhances my clinical acumen and skills over time. Making the right judgement on how best to manage patients who present with side effects from the IP can only come through experience in conducting numerous trials. It can also help one acquire and hone the skills needed to interpret and apply treatment strategies appropriately according to the circumstances that arises.
In your opinion, what are the qualities a PI should possess?
A PI should be vigilant at all time during the course of the trial to ensure that adverse events are identified and resolved early. Equally important is for PIs to have good ethical conduct to ensure that the rights and safety of their subjects are protected and upheld at all times.
What would be your take home message to potential investigators?
Be passionate and remain committed and dedicated to the roles and responsibilities of a PI. At the end of the day, the benefits accrued to the patients should be the ultimate reason for clinicians to get involved in clinical trials.
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