Why is research important?
Many aspects of many diseases affecting human remain
unknown. It is only through clinical research that we can understand
more about ourselves and our diseases.
Am I a guinea pig??
Certainly not!
How are my benefits and interests protected?
All research proposals have to be approved by an independent committee called the Institutional Review Board (IRB), which includes non-medical lay people, and religious representatives, before starting.
The IRB also functions as a policeman to ensure interests of study subjects are being protected throughout the study. The investigators including the doctors and the research nurses have to submit research report regularly to the IRB for audit.
What harms may impose on me if I take part in clinical trials?
Normally, a research proposal will only be approved by the IRB if potential benefits outweigh potential harms.
Some of our trials involve only questionnaire answering, so the risk is minimum.
Some of our trials involve testing of new, investigational drugs,
for treatment of Hepatitis B. Potential harms include ineffectiveness
of the drugs, as well as potential adverse effects. But all investigational
products are tested first in animals and are only tested in human
if they are proven safe. Besides, all study subjects are monitored
regularly by doctors.
What are the advantages for me to take part in clinical trials?
It is only through clinical trials that doctors can test new
drugs to enhance disease control. For example, lamivudine has been
licensed for treatment of Hepatitis B since 2001. More than 1,000
patients worldwide have taken part of research involving lamivudine
before it was approved. Without clinical trials, we can never develop
new treatment for any diseases.
At a personal level, all study subjects in clinical trials have their treatment and follow up sponsored and it saves cost for patients. Besides, study subjects often have the right to experience new drugs for their disease.
For instance, about 22 patients from NUH took part
in one study on adefovir. Adefovir was subsequently found to be as
effective as lamivudine in suppressing Hepatitis B virus, but with
much less adverse effects of emergence of resistant Hepatitis B mutants.
All the 22 patients in that trial received free treatment, follow
up visits, and blood tests for more than 2 years.
Taking part in clinical trials also allows some of our patients
to enjoy the potential benefits of any new investigational drugs.
From your past experience, did any study subjects benefited personally from your research?
Certainly.
NUH had taken part in many clinical trials on investigational
drugs in the past. All subjects who took part enjoyed free medication
and investigations. Many of these patients responded in controlling
their Hepatitis without any charge.
Would my medical care be compromised when I take part in clinical trials?
No.
On the contrary, patients taking part in clinical trials are monitored more often and more vigorously than patients who are just on normal follow up.
What if I change my mind after I agree initially to take part in a study?
All studies are on voluntary basis. All study subjects have the rights to withdraw any time from the study or research. Certainly there will not be any subsequent discrimination and all withdrawn subjects will continue to enjoy normal medical care.
Refusing taking part in a clinical trial does not change the way we doctors and nurses treat you.
How do I know if I am suitable for clinical trials?
Your liver doctor at NUH, who know your condition best, will advise you when you fulfill the entry criteria of our trials.
