Being involved in clinical trials enables physicians to learn more about their area of specialty, become exposed to new medical therapies and provide additional options or alternative treatments for their patients. The following steps are an overview of the process for professionals interested in conducting clinical
- Learn about regulations. Before becoming involved in clinical research, physicians should have a thorough understanding of the various regulations related to the role of the investigator. Understanding these regulations helps ensure study sites are in and remain in compliance. In the United States, individuals 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), which refers to the principles and processes site staff involved in clinical research are expected to follow. Compliance with GCP ensures that the rights, well-being and confidentiality of study subjects are protected. It also assures the collection of reliable data for submissions to regulatory agencies.
- Establish the needed infrastructure. Many physicians plan to integrate clinical research space into their existing practices. To accommodate the conduct of clinical trials, they must consider drug storage, archive space and equipment, as well as providing workspace for clinical research associates (CRAs). Additionally, the practice will need a clinical research coordinator (CRC) on hand, who will handle the management and documentation of the trial.
- Search for clinical trials. Many physicians browse helpful websites, such as CenterWatch.com and ClinicalTrials.gov, while others contact drug companies whose products they prescribe. A physician can also submit his or her contact information into an online database of potential investigators. Many clinical research organizations (CROs), including PPD, recruit clinical trial investigators this way.
- Complete needed forms. Once a physician has been identified as a potential investigator, he or she is required to complete several forms. These forms are required documentation needed to register the physician as a clinical trial investigator and to track and evaluate the ethical and procedural conduct of trials.
Required documents for an investigational new drug (IND) trial in the United States include a confidential disclosure agreement (CDA); Form FDA 1572; a protocol signature page; an investigational drug brochure (IDB) signature page; a curriculum vitae for the principal investigator and sub-investigators; an institutional review board (IRB)/independent ethics committee (IEC) approval letter and roster; laboratory certifications and normal ranges; and the principal investigator’s financial disclosure statement.
- Prepare for a pre-study visit. As part of the qualification process for a newly awarded study, each potential study site will be visited by a CRA to evaluate the investigator’s experience, expertise and interest, as well as his or her staff, facility and potential patient population available for the trial. This visit is called a pre-study site visit. There are also several other items the CRA might want to discuss during the visit, including whether or not the physician is doing any competing studies at the same time.
- Receive IRB approval. An IRB or an IEC is a group designated to protect the rights, safety and well-being of patients involved in a clinical trial by reviewing all aspects of the trial and approving its startup. An IRB or IEC must give approval before any clinical trial can begin and reports on the study progress must be made at specific points during the study. The IRB or IEC also keeps close tabs on the progress of the research throughout the trial.
- Sign the contract and budget. Before the clinical trial starts, the investigator and the sponsor (or a CRO) need to sign a contract and budget. The contract usually outlines the investigator’s responsibilities, including the number of subjects he or she is expected to enroll, timelines for enrollment and the regulatory requirements involved in the clinical trial. It also includes the sponsor’s responsibilities. The budget shows how much the investigator will be paid for study tasks.
- Get ready for a site initiation visit. A CRA will conduct a site initiation visit (SIV) after the IRB or IEC has given its approval and the contract/budget and all essential documents have been completed. The purpose of this visit is to ensure that everything is in place for the investigator to begin enrolling patients.
- Enroll first patients. An investigator (or his or her staff) is usually responsible for recruiting patients, scheduling their visits, retaining them and making sure they are compliant with the protocol throughout the trial.
- Take advantage of the opportunity. A clinical investigator’s role is crucial in the development and advancement of drugs, therapies and medical devices. However, investigators also gain multiple advantages, including the opportunity to learn new skills, explore new challenges and engage with the patients and other healthcare providers in their community.
Some of the information included in these steps is based on the book “Becoming a Successful Clinical Research Investigator” by Dr. David Ginsberg.