Dr. Tan Soek Siam is Senior Consultant Hepatologist and Head of the Department of Hepatology at Selayang Hospital. She is also the National Head of the Hepatology Service of the Ministry of Health (MOH). She obtained her medical degree at Trinity College, Dublin, Ireland in 1991. After completing her postgraduate exams, she returned to Malaysia to serve at both Hospital Raja Permaisuri Bainun and later on at Hospital Kuala Lumpur (HKL) where she began her hepatology specialty training. In 2000 to 2001, she undertook a clinical fellowship at the Institute of Liver Study at King’s College Hospital, London.
Dr. Tan is president-elect of the Malaysian Society of Gastroenterology and Hepatology (MSGH). She is also a council member of the College of Physicians, Academy of Medicine Malaysia and also a member of the Malaysian Transplant Society.
She has published in several local and international peer-reviewed journals and a few book chapters. Dr. Tan has been invited to speak at various international meetings, besides being involved in over 34 industry sponsored and investigator initiated clinical trials. Her area of interests are in viral Hepatitis B and C, autoimmune hepatitis, fatty liver, decompensated and critically ill chronic liver diseases, acute/acute-on-chronic liver failure and liver transplantation.
Dr. Tan first became involved with clinical trials in the late 1990s when she was a trainee at HKL. At that time, she was a co-investigator and it was the advent of new oral drugs for hepatitis B. She recalled her excitement being involved in a ground-breaking clinical trial involving patients with very advanced liver disease in Asia, which included Malaysia.
The study found that the novel treatment could prevent the progression of liver disease in these patients, allowing them to live longer and have a better quality of life. It fulfilled her patients’ unmet needs who in the past, had little treatment options and often did not live for very long. According to Dr. Tan, this study remains heavily quoted in medicine, and it has given hope to patients with advanced liver disease who are now still well and remain under her follow-up. This was the beginning of her interest in clinical trials.
When asked about her current research, she discussed a hepatitis C trial under the Drugs for Neglected Diseases initiative (DNDi) which is sponsored by the MOH through CRM. The study had recently completed investigators meeting and will be conducted in Malaysia and Thailand with a target competitive recruitment of 750 patients. She said that the study progress in Malaysian was well ahead, thanks inno small part to the efforts of Clinical Research Malaysia (CRM) and Clinical Research Centre (CRC). The Malaysian arm of the trial is targeting a recruitment of at least 500 patients.
Hepatitis C treatment is undergoing a revolution just as hepatitis B did in the late 1990s. Cutting-edge medications will enable more hepatitis C patients to live better lives. This revolution is attributed to the background research done by scientists on the lifecycle of the hepatitis C virus. Discoveries have allowed the identification of novel target sites for hepatitis C drugs. Hepatitis C is now rendered curable thanks to these new drugs.
She said she felt truly fortunate being part of this study from the initial discussion starting in 2014 to the protocol writing and now a study that is about to start. The trial will determine an all oral drug regimen that is: effective (defined as able to cure more than 90% of patients), safe with minimal side effects therefore acceptable to many more patients, and easy to monitor while on treatment. She explained that hepatitis C viruses have many genotypes and in Malaysia, 98% of patients belong to only two genotypes (ie genotypes 1 and 3). If the compound is found effective in these two genotypes, many more patients can be treated very easily at a reduced cost and by many more clinicians without dependence on hepatologists.
“We hope this study will translate into a public health approach to control the burden of hepatitis C related diseases by reducing the number of people who may end up with liver cancer, people dying from liver problems, and the need for liver transplants in the country,” said Dr. Tan.
As clinical trials require significant manpower, a big team is dedicated to the study at Selayang Hospital. The team comprises all 3 hepatology consultants, 5 trainee doctors, CRM study coordinators, and a few members of her staff, including pharmacists. A bigger team allows more study days per week to recruit more patients as the patient list is long and they need to be screened thoroughly before being accepted into the study.
The gravity of this trial for Malaysia is not lost on Dr. Tan. The results of the study will help guide the MOH on the future management of hepatitis C in the country. A lot is at stake but she remains optimistic because she has the support of the Ministry of Health, hospitals, university hospitals and senior investigators participating to help realise this opportunity to do a highly relevant study which may in turn pave the way on how clinicians manage the disease in the local setting.
Challenges are nothing new to her but a recurring theme in this line is the difficulty to recruit patients. Even with the best plans laid out at times it can be difficult to get even a handful of patients. She said that patient perception of a study has to be taken very seriously. At MOH hospitals, the medications are free and patients are very happy with their present level of treatment. There is a certain level of patient inertia, restraining them from participating in research to improve their current level of care, even if it could result in a cure.