Rules for clinical trials

After participant safety, the number one priority when conducting any clinical study is to respect study participant’s human rights. In order to show this sort of respect and to acknowledge the selfless contribution of volunteers who participate in clinical trials, IBERICA USA’s study staff believe they need to capture the most reliable and meaningful data possible for use in determining whether marketing authorization is appropriate or not. The way we do this is by only conducting ethically and scientifically sound clinical studies.

This is also the basis for Good Clinical Practice (GCP; a set of international rules to ensure safe, ethical and efficient clinical studies) as implemented by the Food and Drug Administration (FDA).

< GCP Rule 1 >
Pharmaceutical companies must prepare a detailed study protocol (a plan of the study) describing the expected effects of the study drug and what study procedures will be used in each clinical trial. The study protocol must be then be approved by the Study Investigator (the doctor in charge of the study). If the trial is approved by the Investigator, the FDA will review the contents of the study protocol, and demand revisions if there are any issues found. Approval from the FDA must be obtained before it is possible to start the clinical study.

< GCP Rule 2 >
Before conducting a clinical trial, it is first necessary to confirm 1) the suitability of the medical site, 2) that the study protocol is based on sound scientific knowledge, and 3) that the study protocol is designed to protect the rights and well-being of the study participants. The committee that confirms these three points is called the Institutional Review Board (IRB). The IRB should include a committee member with no medical background, and its members should have no vested interests with the pharmaceutical company sponsoring the study or the medical sites involved.

< GCP Rule 3 >
Maintaining the fundamental human right of choice for study participants is one of the primary concerns when conducting clinical trials. In this regard, it should be ensured that study participants can make a decision at anytime whether they want to continue their participation in a study. Prior to enrolling volunteers in a study, the Investigator (the doctor in charge of the study) must first provide volunteers with written information on the purpose of the trial, the procedures to be followed, the expected positive effects and adverse effects, as well as the alternative treatments available if the volunteer is a patient. Volunteers need to provide informed consent in writing to show their participation is of their own free will.

< GCP Rule 4 >
Ensuring the safety of study participants is of the utmost priority when conducting clinical trials. If any unexpected serious adverse events should happen during the trial, the event must be reported to the FDA, and study protocol amended as needed. Volunteers will be informed of any information that might affect their desire to continue participating in the study. If this happens, volunteers will be asked to give written informed consent again.

< GCP Rule 5 >
Medical sites must only conduct clinical studies with a study protocol that is based on sound scientific evidence and is designed to protect the participants’ human rights and well-being. To ensure this is so, the Sponsors of clinical studies (normally pharmaceutical or biotechnology companies) must send Monitors to inspect the progress of clinical study to confirm that the trial is being conducted according to the study protocol and GCP.