Why is the clinical trial phase regulated?

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Answered by: Charmaine, An Expert in the Biotech and Biomedical - General Category
The FDA's Center for Drug Evaluation and Research is in charge of evaluating the overall safety and efficacy of compounds before they are available for public consumption. This is ultimately determined by evaluating the scientific research obtained from clinical trials. However, the FDA must evaluate certain ethical and legal restrictions before this stage of the drug development process can begin.



Due to the scope of the clinical process, establishing ethical standards can prove to be challenging. The Center for Drug and Evaluation Research is in charge of evaluating ethical considerations after receiving the drug sponsor's Investigational New Drug Application. First, they must ask if the potential benefit and safety of the sponsor's new drug compound is worth potentially harming human participants that would volunteer to be in the clinical trial. They must also decide if there is inherent value in conducting a trial for a drug that may be just as effective, or less effective, than a current drug that is already on the market. If the organization can determine there will be a likely medical advancement due to a successful clinical trial, that will also be taken into consideration.

The FDA's Good Clinical Practice's guidelines stipulating that all participants must give their informed consent is another example of the ethical restrictions that must be met before research can be conducted. It would be unethical to administer therapy to participants that did not fully understand the potential non-effect, adverse effects or therapeutic benefits that might occur. It allows people to make informed decisions about their lives and their health. Participants need to be certain that their information will remain private and confidential. The informed consent document also acts as a contractual agreement with the drug manufacturer that their personal data will be protected from the public.



Clinical trials are legally regulated due to the known fallibility of human nature and to ensure the health and safety of its participants. In fact the clinical phase has multiple agencies and committees that are dedicated to regulating clinical trials since the results of its research would affect the health of millions of Americans. Clinical investigators are routinely supervised since they may be swayed by financial incentives from participating sponsors, or the could choose not to comply with their contractual obligations.

Their supervision ensures that most adverse effects are reported, communication between the sponsor and the Institutional Review Board is documented and that all of the informed consent forms are signed before participating in the clinical trial phase. Supervision of the investors can also influence them into keeping complete and accurate information while studying the experimental drugs. The Institutional Review Board also looks for data that may be fraudulent or manipulated. Lastly, the Center for Drug Evaluation and Research's Bioresearch Monitoring Program also conducts on site surprise visits to ensure the quality and integrity of the clinical trial.

While the ethical and legal restrictions can prove to be challenging for everyone involved in the clinical trial phase, it helps ensure the safety of its participants and that investigators and sponsors are held responsible for their actions. Regulations also help improve the chances of a trial's empirical data remaining as accurate as possible so that government agencies can make informed decisions about a compound's fate before it is on the market.

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