Conducting a clinical trial involves much more than just a physician and a patient. The skills of many experts are required in the design and running of a clinical trial. Such skills include; trial coordination, data processing, regulatory management, medical research, and many more. The people who play these roles are vital components in successfully initiating and conducting a clinical trial1.
A successful clinical trial is a product of different personnel, all working together on various tasks at the same time to ensure everything comes together. Matching individuals with appropriate tasks ensures the proper use of the program’s resources and that the team members enjoy and remain challenged by their roles.2 Some of the roles of the core team members involved in clinical trials will be discussed below.
Principal Investigator (PI)
The principal investigator is the lead personnel at the clinical trial site and oversees the conduct of the clinical trial. The PI is most times a medical doctor or a faculty member when the clinical trial is conducted at an academic institution. The PI’s leadership role is the bedrock of any successful clinical trial. Principal Investigators who are doctors can provide their patients with the opportunity to participate in the study, while also assisting pharmaceutical companies in evaluating the safety and efficacy of this investigational treatments3.
The Principal Investigator is responsible for all trial-related activity at the research site. These responsibilities include:
• Developing the concept for the trial
• Writing the protocol4
• Submitting the protocol for approval by the Institutional Review Board (IRB)5
• Directing patient recruitment
• Managing the informed consent6 process
• Supervising the collection of data
• Overseeing the analysis and interpretation of results
In summary, the Principal Investigator is responsible for ensuring the study is conducted in accordance with the requirements of the national regulatory agency and Good Clinical Practice.
A Sub-Investigator is any member of the study team designated and directed by the Principal Investigator to perform key roles and make crucial decisions related to the trial, all of which must comply with the ethical conduct of the study7. The Sub-Investigator may perform some of the Principal Investigator functions, but they do not bear the primary responsibility of the study. A Sub-Investigator can play a number of roles which include:
• Serving as a biostatistician
• Consenting participants
• Treating participants
• Conducting data analysis and obtaining results
• Conducting a basic study on collected samples in the laboratory
Clinical Research Associate (CRA)
A Clinical Research Associate plays a crucial research support role that involves handling the daily conduct of a study. CRAs may either be directly employed by the sponsors7 or the Contract Research Organizations (CROs)8. They are also referred to as Clinical Trial Monitors and have a broad work description. Their main responsibility, however, is to ensure the protection of the rights, wellbeing, and safety of the study participants. CRAs act as the main communication link between the sponsors and the research sites.9 They set up, monitor, and close the clinical trial sites assigned to them.
Some of their common on-job responsibilities include:
• Traveling to and monitoring clinical trial sites to ensure the study protocol, GCP guidelines, and applicable regulations are being adhered to
• Preparation of site visit reports
• Ensuring that only qualified and adequately trained individuals are employed as site staff
• Ensuring that the collected data is accurate and verifiable
• Managing payments for clinical trial sites and handling negotiations
• Ensuring the site’s infrastructure is acceptable and remains so all through the study
• Acting as mentors to the site staff and providing continuous guidance and support
• Ensuring appropriate storage of study documents
The Regulatory Coordinator helps in the establishment of a legal basis for the approval of new interventions.10 Research Coordinators are responsible for preparing or amending the protocol document. They also submit new protocols, amendments, safety reports, and continuing reviews for assessment by the appropriate IRB. This role involves the collection of data from the trial and charting outcomes. It also involves filing compliance reports and coordinating with ethics boards concerning the acceptance process for new interventions11. The following tasks are also part of the roles of Regulatory Coordinators:
• Preparing and recording data generated during the trial
• Reviewing compliance with regulatory requirements
• Monitoring trial procedures
• Submitting data and reports to the appropriate regulatory agencies
In addition to these, Regulatory Coordinators usually keep the delegation of authority logs for top personnel involved in the study.
The Research Nurse works hand-in-hand with the rest of the research team to make sure that every required procedure and visit take place in accordance with the guidelines specified in the protocol. They generally manage the enrollment of participants12 and ensure the conduct of the trial is compliant with the protocol and other regulatory requirements. Their roles include but is not limited to:
• Recruitment of participants
• Assisting the PI with obtaining informed consent
• Educating participants on the study details
• Assessing participant eligibility
• Aiding participant care and follow-up according to a protocol
• Creating source documentation
Although not every clinical trial institution employs research nurses, they play key roles in organizations where they are utilized.
Clinical Data Manager
The Clinical Data Manager is responsible for data management of a research study. They ensure the accurate recording of all the study’s statistical information and results. Clinical data managers ensure robust data quality and identify ways to improve processes by developing and executing data testing and analysis strategies.13 They ensure timely and accurate data entry into electronic databases or report forms.14 They also perform roles such as:
• Working closely with the PI and research nurse to identify key data points to be tracked
• Providing data to monitoring agencies
• Preparing summaries for data analysis
• Working with sponsor monitors and resolving any queries
• Maintaining the confidentiality of data as required
• Resolving operational or data issues
An extensive range of roles involved in conducting a successful clinical from the very first phase to the last. All of these diverse roles cannot be fulfilled by a single individual, and this is where the importance of building the right team comes in. The development and maintenance of a standard research team15 are crucial to the success of any clinical research program. It is important that the roles of each team member are well-defined. The team members must be committed to excellence, communicate effectively, and develop mutual respect for each member’s role.
The use of technology in clinical trial management also helps in making the research management process easier and more efficient. With our data-driven technology and the exemplary study team at ClinicalMatch1, we improve health outcomes and deliver innovative solutions to patients, physicians, PIs, and pharmaceutical companies.
3. Understanding investigational drugs. Adapted from https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-investigational-drugs
5. Informed consent clinical trials. Adapted from https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials
6. Ethics clinical trials. Adapted from https://www.pharmafocusasia.com/clinical-trials/ethics-clinical-trials
7. Clinical trials sponsors and sponsor investigators. Adapted from https://learn.marsdd.com/article/clinical-trials-sponsors-and-sponsor-investigators/
8. Contract research organization. Adapted from https://www.thebalancesmb.com/contract-research-organizations-cro-2663066
11. Development approval process drugs. Adapted from https://www.fda.gov/drugs/development-approval-process-drugs
12. Enrolling clinical trials. Adapted from https://www.eupati.eu/clinical-development-and-trials/enrolling-clinical-trials/
13. What does a clinical manage do? Adapted from https://www.pharmiweb.com/article/what-does-a-clinical-data-manager-do