Research is a structured process of investigating facts and theories and exploring connections. Clinical research is research that either directly involves people or uses materials from humans, such as their behavior or samples of their tissue. A clinical trial is one type of clinical research that is required to prove safety and efficacy of a new treatment or diagnostic test. Lilly-NUS Centre for Clinical Pharmacology conducts Phase I clinical trials to facilitate development of innovative treatments that fulfill unmet medical needs of patients around the world.

Phase I clinical trials are the first studies of a new medicine in humans. These studies provide a preliminary evaluation of safety, tolerance and how the human body absorb and break down the new medicine. The metabolism and pharmacologic actions of the medicine are determined, as well as the side effects associated with increasing doses. If possible, early evidence of effects is gained. Phase I studies are typically closely monitored and may be conducted in patients or healthy volunteers. A clinical research volunteer may receive some form of compensation for time and expenses.

Clinical research volunteers are sometimes referred to as study or research participants or study subjects. People volunteer to take part in clinical research and there are safeguards in place to protect those who volunteer. Examples of safeguards that protect volunteers include the following: study organizers identify risks, they inform potential study participants of the risks, and they formalize a risk-management plan.

One of the primary safeguards for volunteers is that they are informed of the potential risks, benefits and responsibilities of clinical research before they agree to participate. After a volunteer understands the potential risks, benefits and responsibilities, they document their agreement to participate in the clinical trial by signing an informed consent document. This consent is entirely voluntary and a subject may withdraw this consent by communicating with the study investigator or representative.

In Singapore, an ethics committee and the Health Sciences Authority (HSA) will independently review a clinical trial to ensure ethics and safety. An approved clinical trial will have identified risks, if any, which have been minimized with an adequate safety monitoring plan. A clinical trial may not start until approval has been obtained from both the ethics committee and HSA.

New drugs cannot be made available to patients without clinical trials. Your participation in a clinical trial may aid in the development of new drugs in the future. If you are above 21 years old, in good health or have diabetes mellitus controlled on diet or metformin, and are interested in becoming a volunteer, Click here to apply online.