What is clinical research study?
Clinical research study is a study conducted with human volunteers or material of human origin that follows a pre-defined protocol. Some studies involve testing and studying of one or more health-related interventions to see if it is a safe and effective treatment for people. Interventions include drugs, medical devices, medical procedures, preventive care programs, etc. Clinical research helps researchers or doctors to answer specific health questions and find new and better ways to understand, detect, control, and treat illness.
Why participate in a clinical research study?
Participation in clinical research study is on a voluntary basis. Healthy volunteers participate in clinical research study to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others but on top of that, they feel they can play a more active role in their own health care management and receive new research treatments before they are widely available.
Is it safe to participate in a clinical research study?
During the clinical research study, participants may be exposed to some risks, for example,
- New drugs or procedures may have side effects that are unknown.
- The new treatment may be less effective than the standard treatment.
- The trial may require more of your time than your standard treatment e.g. more trips to the hospital.
Before you decide to participate in a study, the major risks in a study will be explained to you by a member of the study team, who will answer your questions about the study and you should carefully weigh these risks.
What safeguards are there to protect participants in clinical research?
Every clinical research study will follow a pre-defined protocol that is approved by the Institutional Review Board (IRB)/Ethics Committee, consisting of medical specialists, statisticians, nurses, social workers, and medical ethicists, who ensure that the procedures of study are ethical and the participants’ rights, safety, confidentiality and well-being are protected. The ethical and legal codes that govern medical practice also apply to research.
What should you do before participating in the clinical research?
If you are interested to participate in a clinical research study, you should find out as much as possible about the study and ask the study team questions about it.
A member of the study team will provide you with an informed consent document that explains the study in straightforward language. You are responsible to read and understand the protocol of the study.
You will be asked to give informed consent i.e. sign the consent form only after you understand the nature of the protocol and agree to the commitment. At any time after signing the consent form, if you feel uncomfortable continuing in the study, you are still free to change your mind and decide not to participate further.
What happens during a clinical research study?
After informed consent, participants will be screened according to the protocol inclusion and exclusion criteria, and, will be enrolled into the study if the criteria are met.
The study investigator will assess the health condition of the participants at the beginning of the trial and during the trials at intervals specified in the protocol. They will give specific instructions to the participants to follow and monitor them carefully throughout the study.
Participants should follow the advice given by the study investigator and make the best possible effort for all the visits and procedures that are outlined in the protocol. Clinical research study participation is most successful when the protocol is strictly followed and the participants keep regular contacts with the study team during the study.
What happens if I suffer an adverse event or an emergency while participating in a clinical research study?
At any point during the study, if you experience any unpleasant adverse reaction or require any emergency attention, you should inform the treating doctor and contact the study investigator or coordinator immediately.
Where can I learn more about the trials available in National Skin Centre?
Please contact National Skin Centre Research Department at 6350 8505 or 6350 8553.