Dr. Irene Looi is a Clinical Neurologist at the Medical Department of Seberang Jaya Hospital, Penang. She obtained an MBBS from the University of Malaya before pursuing MRCP (UK), Fellowship in Neurology and Sub-specialty training in Stroke from the National Neuroscience Institute of Singapore. Prior to her current attachment at Seberang Jaya Hospital, Dr. Irene served as a Neurology Fellow at Penang Hospital, Kuala Lumpur Hospital and University Malaya Medical Centre between 2005 and 2008, and a Clinical Neurologist at Penang Hospital (2008 – 2009).
Over the last several years, she has been a Principal Investigator in numerous multicenter prospective studies from Parkinson’s disease to epilepsy. With almost a decade of experience in industry-sponsored research and investigator initiated research, Dr. Irene has successfully published various research papers in national and international peer-reviewed journals
Dr. Irene recently shared her experience in the clinical trial industry to Clinical Research Malaysia (CRM).
I started off as a Principal Investigator back in 2005 when I was still a neurology trainee at Hospital Pulau Pinang (HPP). An international CRO approached me to take up a Parkinson’s disease clinical trial. While I was interested in this trial, I was worried and apprehensive at first, not knowing what to expect of a clinical trial. It was Dr. Ong Loke Meng’s (Head of CRC at HPP) support and encouragement that gave me the audacity to venture into unchartered waters. HPP at that time had about 160 to 200 Parkinson’s patients and the trial only requested for five subjects. That being said, I managed to recruit 10 subjects for my first clinical trial; giving me the confidence to boldly take up another two Parkinson’s trial that very same year.
Did you have any role model or mentor who was instrumental in your journey as a Principal Investigator?
Most definitely. Dr. Ong Loke Meng is one of them. I have always admired his profound knowledge in clinical research. He is always generous in sharing his experience in this field, imparting valuable advices on ethical issues and supporting me and my research team in more ways than one.
My next role model is Professor Dr. Amir Sharifuddin (Dean of Penang Medical College (PMC)). It was when Prof Amir asked me to be a sub-Investigator in his clinical trial that I learnt how the CRC at PMC functioned. His research team was very organised and systematic. Prof Amir made sure that members of his team are compensated adequately for the time spent in managing a trial and I have taken it upon myself to continue this creditable move in every trial that I conduct.
Who do you feel plays an important part in a clinical trial?
I cannot emphasise enough the role of study nurses/study coordinators in a clinical trial. They act as commanders, from arranging for patients visits to managing specimens and completing the study documentations, to say the least. An experienced team of nurses and study coordinators makes all the difference in the conduct of a clinical trial. Personally, I feel that the nurses at the MOH hospitals are doing an excellent job in being very meticulous in their work.
What are the types of neurology trials have you previously conducted and what are your views on the advances made in neurology clinical research?
I have conducted about 6 – 8 Parkinson’s disease trial, 2 – 3 epilepsy trials and a few dementia trials. Of late, research in neurodegenerative diseases and neurosciences are gaining momentum to find biomarkers that can diagnose disease long before neurological symptoms emerge, and to identify targets for drugs that might halt or slow neurodegeneration. Because of this, we are seeing a lot of new drugs coming into the clinical trial industry to treat these diseases.
What do you enjoy most about being an investigator?
Firstly, being able to provide new and potential drugs to my patients especially those who are in the advanced stages of Parkinson’s disease. For some of these patients, I have tried all the available drugs in the market to control their disease. Yet there are some who still come to me and ask if there are other drugs which they can try. Since taking up clinical trials, I can now offer them these new drugs and it gives them hope for a better treatment.
Secondly, clinical trials help developed a better rapport with my patients. During normal visits, I may only see my patients for 5 – 10 minutes, compared to 2 – 3 hours if they are in a trial. This makes them eager to participate in subsequent trials and thus makes patient recruitment easier.
Finally, by being involved in a trial, I enjoy better networking with my colleagues in other departments as well as with internationally renowned neurologists and neuroscientists.
How has conducting trials affect your clinical practice?
It has changed the way I advise and counsel my patients on diseases like dementia. Before, my response to their queries on prognosis was that it is a neurodegenerative disease and it will progressively worsened, with no definitive cure. Now, I am able to tell them that although it is degenerative in nature, many clinical trials are currently underway and a new potential drug may be discovered in the near future. This gives them hope and optimism to deal with their disease.
How important is it for an investigational drug/product (that showed significant benefits to patients) to be continued even after a study closes?
Very important indeed. In normal scenarios, the trial drug will be stopped after a study closes. However, most sponsors will allow for compassionate use of the investigational drug until that drug is marketed in Malaysia. Should a Principal Investigator (PI) want the investigational drug to be continued in their patients after a study closes, the PI must ensure that this clause is included into the Clinical Trial Agreement before signing this all-important document.
Can you recall of any patients who have benefited from a clinical trial which you conducted?
I had a 60-year old patient who had been on two different anti-epileptic drugs which did not seem to be working on her. However, when she enrolled in an epilepsy trial, her seizure’s got under controlled. I managed to get the sponsor to continue that drug on my patient and they were more than willing to agree. She has been on this drug for the past three years and so far there has been no recurrence of seizures.
What kind of breakthroughs in neurology do you wish to see in the next 5 to 10 years?
It is my hope to see breakthroughs in new drugs and interventions for neurodegenerative diseases that can not only prolong life but most importantly improve the quality of life of these patients.
CRC Seberang Jaya has recently been accredited by NPCB as a Good-Clinical-Practice compliance bioavailability bioequivalence site. How will this accreditation affect the conduct of clinical trials in CRC Seberang Jaya?
This accreditation encourages the CRC research team to be consistently GCP compliant, prioritize patient safety and ensure the quality of data storage. With this accreditation, we have also had offers from sponsors overseas to conduct a bioavailability trial here.
What advice would you give to young clinicians who wants be involved in a clinical trial?
Clinical trials are the future to modern medicine and as clinicians, we have to embrace it, like it or not. CRC is always here to help those interested to take up clinical research. When I first got started, clinical trials seemed to be like a daunting task. Later, I found that it was nothing of that sort. Teamwork is the key to successfully conducting a clinical trial. So don’t worry too much and just do it!
source: https://clinicalresearch.my/research-personality-dr-irene-looi/
