The Roles of the Core Study Team in Clinical Trials
by Ayesha Bhargava Basic KnowledgeConducting 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.
Sub-Investigator
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
Regulatory
Coordinator
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.
Research
Nurse
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
Conclusion
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.
References
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3092661/
3. Understanding investigational
drugs. Adapted from https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-investigational-drugs
4. https://en.wikipedia.org/wiki/Institutional_review_board
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
9. https://www.jli.edu.in/career_clinicaltrials/cra/
10. https://www.careersinpublichealth.net/careers/regulatory-coordinator/
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
14. https://ccts.osu.edu/content/responsibilities-research-team
15. https://www.clinicalmatch.com/about#ourteam
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Created on May 26th 2020 14:06. Viewed 250 times.