Clinical trials are research studies done to analyze the safety and efficacy of a drug, treatment or device on humans. It requires participation of both patients and healthy individuals. Results obtained from clinical trials help to determine what treatment is best for patients with a specific medical condition, and if it is associated with any harmful effects.
Participants always have questions on their mind when they enrol for a trial. ‘How safe am I in the hands of researchers?’ ‘What if something happens to me during the study?’ ‘Who is responsible if there are adverse effects of the drug?’
Before looking into the answers for these questions, let us understand that any clinical trial that takes place is required to be registered with the concerned authorities who monitor and audit them on a regular basis. This is the first and foremost important step that ensures patient safety in a trial. The clinical trial protocols have to be reviewed and approved by the Institutional Review Board (IRB). Monitoring of ongoing trial is done by the IRB and Data Safety & Monitoring Committee (DSMC) to ensure safe and reliable ways of conducting trials.
Even before a participant is enrolled into a clinical study, he/she must be provided with all information regarding what, why and how the drug is being tested, and the possible effects the drug may have. Once this information has been communicated to the participant, an informed consent form is signed by the participant, which indicates that he/she has received and understood the purpose of the study. All documents related to participants, including their physical examination reports prior to the drug administration and consent forms, are to be maintained at the trial sites. Internal committees have to ensure that all participants are treated as per a single protocol. Any changes in protocols based on individual patient requirements must to be communicated to concerned authorities for approval and discussed with the concerned patients.
The sponsors or contract research organizations (CROs) have to ensure that they have qualified and trained staff involved in their studies to handle any adverse events. Studies related to high mortality conditions such as AIDS and cardiac problems require additional safeguarding of participants. The DSMC has the responsibility of looking into all measures to ensure such participants do not face any problems during the trials.
Apart from setting up committees and obtaining written consents, trials must also ensure to:
- Obtain audio-visual consent from participants.
- Arrange for regular follow-up examinations after drug administration.
- Provide treatment within 24 hours, in case of any serious adverse effects of drugs.
- Compensate the participant adequately in case of serious adverse effects.
A patient or participant is free to get clarifications on any issues concerned with the clinical trial at all times. He/she does not have any obligations to be a part of the study until its conclusion. Any form of abuse to patients noticed during audits can result in disqualification of investigators and halting enrolment of participants for ongoing trials.