Source: Asian Scientist Magazine. Permission required for reproduction.
Some medical devices have wide application and reap big returns for companies. But what about those that only benefit a restricted group of patients? CEO of the Singapore Clinical Research Institute (SCRI), Dr. Teoh Yee Leong, shares how academic research organizations help put patients first by trialing such medical devices.
Tell us about SCRI.
SCRI is an academic research organization (ARO) and our vision is to be the ASEAN hub of academically oriented clinical research. We are involved in various types of clinical research including pharmaceutical drugs, vaccines and medical devices. As a government-funded ARO, we help many Singapore based researchers coordinate large-scale, multi-country clinical trials from Singapore. We may do similar work to a contract research organization (CRO), but the key difference is that we are not bottom line driven and our primary aim is to benefit patients.
Who are your partners?
Our partners are both public sector physicians as well as private sector funders. Many of our studies are jointly funded by the Singapore government through the National Medical Research Council and also by private pharmaceutical companies who may provide the expensive drugs and devices and even co-fund a portion of the research costs. This model of private-public partnership is useful in advancing Singapore’s capability in clinical research because unlike traditional pharmaceutical sponsored studies driven by commercial companies, these types of large-scale studies are typically driven by Singapore based researchers and supported by SCRI.
How is Singapore growing into an Asian clinical research hub?
Although Singapore has a smaller population base compared to other Asian neighbors like Malaysia, Indonesia, Thailand and Philippines, we are strong in key areas. For example, the standard of healthcare here is very high and we design good research hypotheses. The government has dedicated many resources in terms of funding for research, training for healthcare professionals and building key infrastructure such as advanced hospitals and research institutes. There is strong oversight over clinical trials by ethics boards comprising independent doctors. With these resources and capabilities, we partner with our larger population Asian neighbors to look for solutions to important clinical research questions. For example, in a dengue study we are conducting in Singapore, we are collaborating with sites in Malaysia because they have dengue cases similar to Singapore.
What kind of trials does SCRI carry out?
Other than traditional drug clinical trials, we are also conducting vaccine and medical device trials. Many of our trials have global public health impact. For example, in the dengue study, we are helping infectious disease researchers to study if there is a need to transfuse platelets in dengue patients to prevent bleeding. If the results show that there is no need to transfuse platelets, this will change the way we manage dengue cases and reduce both cost and complications to the patients. In another study, we are studying whether a highly affordable, widely available drug such as aspirin can improve the survival rate of colon cancer patients.
One good example of a regional trial that SCRI is facilitating is a Phase III clinical trial to treat patients who have locally advanced liver cancer. Launched in July 2010 under the Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC), the trial involves 28 centers in 11 countries including Korea, Hong Kong, New Zealand and Malaysia. This trial shows that Singapore is able to coordinate large-scale investigator-initiated clinical trials in the Asia Pacific region through collaborations with clinicians in other countries. For the future, we look forward to conducting clinical trials of “Made in Singapore” products, which are currently in early stages in various research laboratories across Singapore.
What types of medical devices have SCRI trialed?
Currently, about 20 percent of our work is related to medical devices. Medical device trials are unique because devices are a heterogeneous group. Some are diagnostic devices, whereas others are therapeutic devices. This is unlike conventional drugs, which are mainly for therapeutic uses and not for diagnostic uses.
Some devices may also be coated with drugs and thus the performance of the device depends not only on the device but also the drug in the device. Thus, these drug-device combination trials, which are usually designed to look for specific relevant outcomes, tend to present more challenges as compared to traditional drug trials.
Among the interesting device studies that SCRI is currently supporting is the AHCC network study on liver cancer treatment. The randomized trial seeks to assess the effectiveness of two widely used treatments, Sorafenib and SIR-Spheres, for locally advanced hepatocellular carcinoma, which is a liver cancer that has not spread outside of the liver. Sorafenib is a chemotherapy drug from Bayer while SIR Spheres microspheres is a medical device manufactured by Sirtex used in interventional oncology to deliver selective internal radiation therapy (SIRT) to the liver. In this case, medical devices as an alternative form of treatment is useful as the device would only need to be implanted once whereas conventional drugs require daily dosing.
In another trial, we are studying the cognitive enhancement of a braincomputer interface (BCI)-based system on certain groups within our population. Specifically, the aim of this study is to examine the efficacy of BCI-based treatment of inattentive symptoms in attention deficit hyperactivity disorder (ADHD) among children aged 6–12 years old. This trial is carried out in collaboration with Duke-NUS, the Institute of Mental Health, and the Intelligent Systems for Personalized and Connected Healthcare group of the A*STAR Institute for Infocomm Research. A third study is to support a medical device manufactured by Medtronic. It is a simple catheter procedure to remove excess nerve signals to and from the kidneys, called renal denervation, and we hope to show that it can be used to reduce blood pressure in heart failure patients. This study is a collaboration between investigators in Singapore and counterparts in Australia and New Zealand. First enrolments of study subjects have already begun.
What key trends do you see for medical devices in Asia?
Using mobile apps is a key trend that is likely to increase as the penetration of smartphones into Asia grows. For example, there is a study, not done by us but by a partner organization, on the effectiveness of a mobile app in helping Type II diabetes patients new to insulin therapy. The app helps take the guesswork out of insulin injections by informing users of the required dosage based on the fasting blood sugar reading they input into the app every morning. In addition, as our population ages, there will be greater demand for medical devices that cater to the elderly and those with chronic diseases.
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