Research Personality: Dato’ Dr. Faraizah
Dato’ Dr. Faraizah Dato’ Abdul Karim Deputy Director and Senior Consultant Pathologist, National Blood Centre, Kuala Lumpur
Dato’ Dr. Faraizah Bt Dato’ Abdul Karim is an internationally recognised expert in haemophilia care and has a longstanding interest in blood transfusion services. She is currently the Deputy Director and a Senior Consultant Pathologist, specialising in haematology and blood transfusion, at the National Blood Centre, Kuala Lumpur.
Dato’ Dr. Faraizah earned her medical degree from Universiti Sains Malaysia and a Diploma in Clinical Pathology from the University of London. She then went on to obtain a Master of Science in Haematology at the Imperial College School of Medicine before embarking on sub-specialty training in transfusion medicine at the North London Blood Transfusion Service and Hammersmith Hospital, London.
Before assuming her current position, she served as Deputy Director and Consultant Pathologist at the Blood Services Centre in Hospital Kuala Lumpur from 1998 to 2000. She is further engaged in various committees and drafting of policies and guidelines at the Ministry of Health Malaysia, and has been invited as a speaker at conferences in Hong Kong, Sweden, Taiwan and the Philippines, among others.
Dato’ Dr. Faraizah has been the Principal Investigator in more than 20 multi-national clinical trials and has co-authored papers reporting clinical trial findings in several international peer-reviewed journals. She is a member of various international societies including the International Society of Blood Transfusion and the World Federation of Haemophilia. Currently she is the President of the Haemophilia Society of Malaysia and Vice President of the Malaysia Blood Transfusion Society.
Dato’ Dr. Faraizah, can you briefly describe how you first got involved in clinical research?
My first trial was in 1997 when I was at Hospital Kuala Lumpur (HKL) managing haemophilia patients. During that period, most of the haemophilia patients were not responding to the treatments that were available and my colleagues and I had nothing else to offer. We jumped at the opportunity when a sponsor wanted to bring in a haemophilia trial to HKL. It was at this time that I first got involved in clinical trials and became a sub-investigator. The trial drug showed positive results and the patients responded well. The success of this first trial set the precedence for subsequent trials to be conducted at HKL and Pusat Darah Negara (National Blood Centre).
What are the type of trials that you mostly conduct?
Only haemophilia trials and these are all industry-sponsored research. My first was a Phase III trial followed by a post-marketing trial and Phase II trial. When my superior, who was the then hospital director and principal investigator retired, I took on the role of principal investigator. Here at PDN, Phase I trials are conducted in collaboration with HKL whereby we have been provided access to the critical care unit (CCU) beds, necessary for any first-in-man studies.
What are the aspects that you look for before agreeing to undertake a trial?
Apart from reviewing the protocol, I try to ensure that the trial drug would bring potential benefits to my patients by studying published journal articles of that particular drug or treatment. Only when I am convinced of the possible advantages of the drug will I undertake the study. This may be one of the reasons why patients have placed their trust in me. As with any clinical trial, the safety of patients is our utmost priority and it is our responsibility to safeguard their interest.
As the Deputy Director of PDN (National Blood Centre), what do you see are the strengths of PDN with regards to conducting clinical trials?
Over the years, PDN has secured itself as an established site with a track record of numerous successful multi-national haemophilia trials being carried out here. While at the moment I am the only principal investigator at PDN, we have a number of young sub-investigators who are well-trained and dedicated to the trials that are conducted here.
You have been invited by some sponsors to contribute or author research papers arising out of multi-national clinical trials. Why do you think this is so, and how many journal papers have you co-authored so far?
Every sponsor has their own selection criteria. In my case, I understand that it was based on the number of patients which I have recruited and the inputs that I provided to the trial. Thus far, two papers out of five which I co-authored have been published while the rest are still under review.
If an investigator and the sponsor have a difference in opinion, say over the trial results, how do they resolve this and move on to writing journal papers?
A meeting would usually be held between the author and co-authors, and during this time, all contributors will discuss and come to an agreement on the data that we want to be presented in the manuscript.
How do you influence or encourage your sub-investigators to conduct clinical trials?
I wouldn’t say that I personally influenced them. Their involvement in trials stem from their interest in managing haemophilia patients and maybe to a certain extent looking up to me as their role model. In fact, I have a few medical officers who are keen to conduct trials and have expressed their interest to do so once they complete their master’s programme.
What would be the hardest part in conducting a trial
That would be a protocol that is not well-defined. A clearly well-defined protocol is of paramount importance to all investigators as it is at this stage when we decide if we want to undertake the trial.
Is it difficult to recruit patients for haemophilia trials?
The level of difficulty very much depends on the phase of the trial. For example, it is easier to recruit patients for Phase III trials compared with Phase I and II because there are more established results available to show if the study drug or treatment is beneficial. As with any trials, I try to treat my patients as if they were my own family members, giving them the best treatment available but at the same time not compromising their safety and health.
What advice do you have for young investigators who are keen to follow in your research footsteps and author research papers?
For young investigators, it is important for them to learn how to conduct a trial and manage it with absolute dedication. Once you have made your mark in the clinical trial industry, further trials and requests for research papers will come naturally.
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