Your safety is protected in clinical studies
The goal of clinical trials is ambitious – to introduce life-changing medicines. But just as important is the safety of the study participants. That’s why there are strict regulations and processes in place to protect trial volunteers
at every step. Nations around the world establish and enforce rules of ethical research to make patient safety a priority.
The four most important principles of clinical trial safety are:
- Informed consent – Volunteers should understand the risks involved in the trial and willingly participate. They can ask questions about the study and how it affects their health at any time during the study.
- Professional conduct – The study must be done by qualified researchers and follow an approved research design.
- More benefit than risk – While there is always some risk in a clinical trial, the potential benefits of the research must outweigh the risk.
- Personal freedom – Volunteers are free to end their participation at any time during the study without penalty.
How do clinical trials protect patient safety?
When researchers design clinical trials, they pay careful attention to building in safety measures. For example, they start with the lowest possible dose of the medicine and closely monitor any adverse effects. Most countries require an independent oversight committee to review clinical research to protect the rights and welfare of the study participants.
In the United States, trials involving people must be approved and monitored by an Institutional Review Board (IRB). This committee of physicians, scientists, statisticians, community members and others are not involved in the trial. They evaluate the study protocol or design to make sure it will not pose unnecessary risk to those who participate and review reports of adverse effects throughout the trial. Other countries have their own versions of this oversight board.
At different stages of a clinical trial, investigators report the results at scientific meetings, to medical journals and to government agencies. This reporting helps make sure the process remains open and transparent. Rest assured that the names of participants are never shared in these reports.