Clinical Trial: Ensuring Safe and Good Practices
All Focus On articles are contributed by
Ms Low Ai Lin
Senior Manager, Clinical Trials Office,
Division of Clinical Trials and Epidemiology, NCC

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of people may enter the trial, schedules of tests and procedures, drugs, dosages and length of trial, as well as the outcomes that will be measured. Before a clinical trial can begin in Singapore, the protocol must be reviewed and approved by an Institutional Review Board (IRB) and the Health Sciences Authority of Singapore (HSA).

The IRB functions as a clinical trials clearing house to ensure that the protocol is scientifically sound, the trial is ethical to be conducted. In addition, the IRB also ensures that the following conditions are fulfilled:

• Investigators are qualified;
• Risks to participants are reasonable in relation to the anticipated benefits and are minimized as much as possible;
• Participants will be selected fairly;
• Consent will be obtained from participants and the written patient information and consent form is both ethically and legally sound, and is comprehensive to subjects;
• Provisions have been made to monitor the data collected to ensure safety;
• Provisions for protecting the privacy and the confidential data of the participants have been included.

After giving approval to conduct the trial, the IRB continues to monitor the progress of the trial to keep track of patients’ safety and to ensure that the results and ethics of the trial are above reproach. The HSA issues a trial certificate which allows the investigator to conduct the trial. It also monitors the progress and safety of the trial.

The written patient information and consent form contains most of the information that could help a subject to make an informed decision whether to participate in a clinical trial. It should give a summary of the trial including its purpose, treatment procedures and schedule, potential risks and benefits, treatment alternatives, costs of participation and explains subject’s rights as a participant. It is designed to begin the informed consent process which consists of conversations between the potential subject and the trial team. The purpose of the informed consent process is to help potential subjects gather and understand sufficient information about the trial so that they are able to make educated decisions about their participation. Hence, the process should provide ample time and opportunity for the potential subjects to ask questions and raise concerns. The consent process does not stop after the patient has given consent for participation. It is an ongoing procedure that requires the investigator to continue to update the subject on any new information that may affect the subject’s decision to continue participation. The subject should keep a copy of the signed consent document as a helpful resource. If the subject has questions about the trial or their participation at any point of time during their participation, the subject is free to ask the investigator. The subject can also withdraw from the trial for whatever reasons without penalty or loss of benefits to which the subject is otherwise entitled.

The conduct of clinical trials has to be compliant with recommended guidelines and regulations. In Singapore, it is mandatory to comply with the Singapore Good Clinical Practice Guideline (SGCP) when carrying out clinical trials. The SGCP is an ethical and scientific standard for designing, conducting, recording, monitoring and reporting clinical trials. It governs the type of information to be included in the patient information and consent form to ensure that information included is both comprehensive and sufficient. For trials that are intended to be used for the registration of drugs with the US Food and Drug Administration (FDA), the FDA code of federal regulations pertaining to the conduct of clinical trials must also be complied with. Compliance with these standards also provides public assurance that the rights, safety and well being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.