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Clinical research is health related studies to determine the safety and effectiveness of medications, devices, diagnostic products or treatment regimens intended for human use.
There are different types of clinical research:
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.
In a Phase I trial, researchers test an experimental drug or treatment in people for the first time. It is tested in a small group of people (20-80) to evaluate its safety, determine a safe dosage range and identify side effects.
In a Phase II trial, the experimental study drug or treatment is given to a larger group of people (100-300) to determine whether it is effective and to further evaluate its safety.
In a Phase III trial, the experimental study drug or treatment is given to a large group of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly-used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In a Phase IV trial, post-marketing studies gather additional information including the drug's risks, benefits, and optimal use.
An investigator-initiated study is an application where the investigator is conducting the study and acting as the sponsor. The investigator both initiates and conducts a clinical trial, alone or with others. The investigational product is administered to, dispensed to, or used by a participant under the immediate direction of the investigator. An investigator-initiated study does not include a corporation or an agency. The obligations of the investigator include both those of a sponsor and those of an investigator.
You can play a more active role in your own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
All clinical trials have guidelines regarding who can participate. Inclusion and exclusion criterias are used and you must fulfill these in order to be eligible for the trial. Adherence to these criteria is essential for your safety and the research team will ensure this is thoroughly checked. Factors such as age, gender, pre existing medical conditions and treatment history may be reviewed.
Depending on the nature of the trial, it may require healthy volunteers and/or those with an existing medical condition that is being studied in the trial.
Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. To help you make this decision, the doctors and nurses involved in the trial will explain the details of the study to you. If your native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures and key contacts. Risks and potential benefits are explained in the informed consent document. You can then decide whether or not to sign the document and participate in the study.
Informed consent is not a contract. You may withdraw from the trial at any time.
All clinical research conducted in Singapore must be approved by a body of scientists, doctors, medical professionals and members of the public. This body is collectively known as an Institutional Review Board (IRB) or Ethics Committee (EC). This group will review the proposal in detail and in particular assess the potential risks versus the benefits. Only if there is a clear benefit will the research be approved. They will also ensure your protection of rights, confidentiality and well-being.
Clinical trials involving drugs also require additional approval from Singapore’s Health Sciences Authority (HSA). This ensures that there is a regulatory framework in place in Singapore for all pharmaceuticals, medical devices and other health products.
Whilst participating in a clinical trial, you will receive close medical attention from the clinical trial team (doctors, nurses, trial coordinators, other health care professionals) and they will continue to care for you after the trial has finished.
Yes. You can leave a clinical trial at any time without any penalty.
A protocol is a clinical trial study plan. The plan is carefully designed to safeguard your health in addition to answering specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
A placebo is an inactive pill, liquid or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of participants will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
