Q. What are clinical trials?
Clinical trials are designed to assess if a new medication or treatment combination is safe, effective, and/or better than currently available treatments.
Q. What are the benefits and risks of participating in a clinical trial?
All treatments that are being used in the clinic have gone through a rigorous process to test their safety and efficacy in a clinical trial setting before obtaining regulatory approval. Clinical trials are essential for the development of new treatments for cancer patients, and have been vital for the many effective treatments that we have today in our clinic.
Our unit is recognised as a leading centre for early phase studies on cancer drugs. Early phase studies evaluate the safety and effectiveness of novel cancer drugs. These novel therapies can provide alternative treatment options for patients who have exhausted standard treatment options.
As a participant of an early phase clinical trial, you may be one of the first few people to benefit from a new treatment or a new treatment combination, sometimes years before they become widely available. In addition to a potential personal benefit, participants will also be making valuable contributions towards the development of new cancer treatments that can benefit future patients.
However, a clinical trial can sometimes require more time and medical attention than normal care. This can include additional doctor visits, follow-up phone calls, study procedures and sometimes additional biopsies of the cancer. While the new cancer drug may work for some patients, there is no guarantee that it will be effective. Additionally, while every effort is made to ensure your safety on study, new treatments may lead to unforeseen serious side effects that may have long term after effects. To mitigate these risks, you will be reviewed regularly while you are in a clinical trial, and our team at HORG is also always contactable should you experience any discomfort during the study.
Q. Are clinical trials safe?
Ensuring your safety in a clinical trial is of paramount importance.
From a regulatory standpoint, the conduct of clinical trials in Singapore is regulated by the Medicines Act 1975 and the Medicines (Clinical Trials) Regulations 2000.
Our clinical trials are under the oversight of the Domain Specific Review Board (DSRB) and regulated by Health Sciences Authority of Singapore (HSA). The National Healthcare Group (NHG) DSRB is an independent institutional review board that ensures the research is ethical, the risks are as low as possible and the potential benefits of the trial treatment justify the risks. All research studies must be approved by DSRB before they are carried out by the HORG team at NCIS.
Within the hospital, a collaborative team of doctors, nurses, pharmacists and trial coordinators work together closely to ensure your safety on the trial. The team is in regular contact with the manufacturers of the new drugs to obtain up-to-date information of the drugs, and you will be monitored closely for side effects throughout the study. Study findings are also reported back to the regulatory authorities who review the results to ensure that it is safe to continue the clinical trial.
Q. Am I eligible for clinical trials?
Each study has its own guidelines on who can participate in a clinical trial. The most common criteria used to determine suitability for participation would include age, gender, type and stage of cancer, cancer treatment history, other medical conditions you might have or medications you are taking.
Click here to see the list of active clinical trials at HORG and their eligibility criteria.
Q. What is informed consent?
Informed consent is the process of learning about the clinical trial before you decide to take part in it. The research team running the trial will explain the trial’s purpose, the duration, what will happen, all potential risks and benefits, and provide information on the privacy of your medical records.
You may take as long as you would like to decide if you wish to participate in a clinical trial. If you do decide to participate, you will be asked to sign a consent form that will provide details on all key aspects of the clinical trial. You will be able to take that form home and refer to it at any time. Even though you have signed the consent form, you have the right to leave the study at any time and for any reason.
Q. Can I withdraw from a clinical trial?
Yes, you can withdraw from a clinical trial at any point of time without penalty or compromise to the medical care you are entitled to.
Q. What happens during a clinical trial?
Upon enrolment in a clinical trial, you will work closely with the clinical trial team which would include doctors, nurses, clinical trial coordinators and other health care professionals. You will have direct contact with a dedicated clinical trial coordinator at all times until the end of the study. You will be supported by the coordinator who will coordinate all the required tests and procedures when you are in the trial. Clinical trial coordinators, working alongside the primary doctor, will ensure that your concerns are met throughout the study.
Q. What are my responsibilities as a participant?
Your responsibilities as a research participant are:
- To understand the information communicated to you during the informed consent process and clarify any doubts you may have before agreeing to take part in the study
- To comply with the study treatment, tests and doctor’s consultations
- To adhere to the instructions in the study protocol
- To report any side effects you are experiencing to the study team
- To answer research questionnaires truthfully to the best of your abilities
