Being involved in clinical trials enables physicians to grow and take advantage of new medical therapies for their patients and allows them to provide additional options or alternative treatments that may not otherwise be available. However, before becoming a Principal investigator or Co-investigator it is important to realize that there are additional requirements outside of your regular clinic.
Before becoming involved in clinical research, physicians should have a thorough understanding of the various regulations that govern clinical research. This will help them remain in compliance. In the United States, physicians conducting clinical trials should be familiar with parts 50, 54, 56 and 312 of the Code of Federal Regulations (CFR) Title 21. These regulations define what is required by the U.S. Food and Drug Administration. Other countries have their own requirements.
Those who want to conduct trials should know about good clinical practice (GCP). This refers to the principles and processes investigators are expected to follow when interacting with patients.
Conflict of interest training is also required. This training ensures that you are aware of the things that may have undue influence on study results and ensures the research is conducted in an objective way.
All of this training will be completed through CITI and is required prior to submitting a study to the IRB. To obtain instructions on getting access to this training, reach out to the NCH IRB office.
The next step is obtaining IRB approval. This is done either through NCH’s IRB or a Central IRB. If your study is using a central IRB, you will need to still submit a “Ceding IRB Oversite Request Form” to the NCH IRB to document this relationship. An IRB is a group of diverse individuals who review studies to ensure the protection of the rights, safety and well-being of patients involved in a clinical trial. They review all aspects of a trial and must approve its startup before it can begin and also review the studies progress throughout the life of the study.
Before committing to becoming a principal investigator or co-investigator it’s important to consider that more time will be required of you than if your patients receive standard of care treatment outside of a clinical research studies. Clinical research studies are carefully planned to ensure each patient meets the same eligibility criteria and is undergoing tests and procedures in the same way. Because of this, there is training you will need to attend regularly while the study is open.
Additionally, more information is required from patients who are participating in a clinical research study, and as PI or Co-I, you will have to review and sign off on more tests and procedures than you are used to.