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Trial planning July 17, 2024

How to assemble your clinical trial team

Assembling a clinical trial team is a critical step in the success of any research study. This blog will explore the essential roles and responsibilities of a clinical trial team. From principal investigators and data managers to consumers, each member is vital in driving the trial towards meaningful and reliable outcomes.

Why your clinical trial team matters

A well-rounded and skilled team is essential for the success of a clinical trial. Building the right team will ensure the trial is conducted efficiently, ethically, and in compliance with regulatory requirements.

Two important factors in a successful clinical trial are assembling a diverse team with the right composition and defining the role and contribution of each team member. Developing the trial team early on in the process will help avoid several problems that can occur in a clinical trial.

Who is included in a clinical trial team?

There are a number of roles that build a good clinical trial team. However, not all trials will need all roles. Although there are a few central key roles to every trial team, there can also be considerable overlap with regard to the tasks performed by each team member.

Sponsor: The trial sponsor is the organisation that has overall responsibility for a clinical trial. In Australia, an Australian entity must sponsor the trial. Sponsors can be commercial companies, universities, government entities, health service organisations, collaborative research groups, and even an individual investigator. The sponsor is responsible for the trial initiation, management and financing. It is also responsible for handling the medico-legal risks (providing indemnity and appropriate insurance), obtaining appropriate approvals (such as the CTN/CTX to the TGA, if applicable), and adhering to conditions of approval.
Principal Investigator (PI): The Principal Investigator (PI) is the lead researcher responsible for the overall conduct, management and oversight of a clinical trial. They ensure the clinical trial is conducted ethically, scientifically, and in compliance and in accordance with the approved clinical trial protocol and regulatory requirements. The PI is the person responsible for the research team and protecting the rights and safety of trial participants under their care.
Co-Principal Investigator (Co-PI): It may be necessary to have a Co-Principal Investigator (Co-PI). A Co-PI may have experience in a slightly different field and bring a different expertise to the conduct of the trial. A Co-PI at a different site bears the same responsibility for their site as the PI does at their trial site.
Clinical Trial Coordinator: A Clinical Trial Coordinator (also known as the Study Coordinator or Research Nurse) is a key role that works with the PI in the conduct of the trial. Their role involves helping prepare the trial documentation for ethics and site approval (where applicable). During the trial, they interact with participants in the screening process, study enrollment and study visits. They ensure all documentation is entered into the trial site file and master file (where applicable). A Nurse Coordinator may also be able to take on clinical tasks such as conducting patient vital sign assessments.
Biostatistician: A Biostatistician assists in the trial design to ensure it addresses the research question. They also determine the sample size needed to detect a meaningful effect. They will assist in the design of the protocol for data collection to ensure data quality and integrity and that activities are in line with Good Clinical Practice (GCP) guidelines. They will also conduct interim analyses to monitor safety and efficacy, providing data to the Data Safety and Monitoring Board (DSMB). Once data is collected, the Biostatistician will perform a comprehensive analysis of the interventions being tested.
Data Manager: A Data Manager is responsible for ensuring the integrity, accuracy, and security of the data collected throughout the study. Their role can be similar to the role of a Biostatistician and both may not be required. The Data Manager is critical in maintaining high data quality standards. The Data Manager will be involved in tasks such as developing the Data Management Plan, coordinating an electronic data capture process, and generating the interim and final analyses.
Economist: An Economist is not necessarily required for all clinical trials. Economists will be involved in trials that primarily involve assessing the economic implications and cost-effectiveness of the treatments being tested. Their expertise is crucial in determining the value of new medical interventions from a financial and resource allocation perspective.
Consumer representative: While not an operational clinical trial team member, a consumer representative who has lived experience of a health issue can bring valuable guidance, insight and feedback to shape the protocol and how the trial is conducted.

What training is essential for all team members?

To ensure the successful conduct of a clinical trial, all team members must receive comprehensive and continuous training. This training encompasses various aspects of clinical research, regulatory compliance, ethical considerations, and specific trial-related procedures. Ensuring all team members are well-trained enhances the quality and reliability of the trial and safeguards the rights and well-being of participants.

Essential training required for clinical trial team members may include:

Good Clinical Practice (GCP) training: Good Clinical Practice (GCP) is an internationally accepted standard for designing, conducting, recording and reporting of clinical trials. GCP is widely adopted as the standard for all clinical research. GCP training must meet the TransCelerate Biopharma Inc criteria. There are a number of course providers in Australia. Learn more
Protocol-specific training: Team members and site staff (for multi-centre trials) should be provided with detailed instructions on the trial protocol to ensure all members understand the study objectives, procedures and individual responsibilities.
System and procedure training: Members of a clinical trial team should be trained on the systems and procedures for data collection, entry and management. Such systems might be the e-consent form or the system being used for data collection (e.g. REDCap). If using a clinical trial management system, team members should be trained on navigating the system, tracking milestones, and reporting functionality.
Safety and adverse event training: Team members should be knowledgeable with regard to identifying, documenting and reporting Adverse Events (AE) and Serious Adverse Events (SAEs). Teams need to understand the definition and classification of adverse events, their reporting timelines and procedures, and, following a SAE, any safety monitoring and risk management.
Standard Operating Procedure (SOP) training: Familiarising team members with the trial’s governance SOPs ensures consistency and compliance with both organisational operations and regulatory standards. Training should be provided for study-specific SOPS, organisational SOPs, compliance, documentation and record keeping.
Role-specific training: Specialised training may be required depending on the team member’s role and responsibility. For example, a coordinator may need training on day-to-day trial management, whereas a Co-Investigator may require training on consenting a participant.

What ongoing support does my trial team need?

Trial Steering Committee

The clinical trial team is involved in the day-to-day operations and running of a trial. However, a clinical trial also requires an independent team, known as the Trial Steering Committee (TSC), to oversee all aspects of the trial.

The main responsibilities of the TSC are:

overall oversight of the trial’s progress and adherence to the protocol
ensure the trial complies with ethical guidelines and protects the rights, safety and well-being of participants
identify and manage risks
make key decisions regarding the trial’s conduct as to whether to modify, continue or terminate the study based on reviewing interim analysis
review trial progress, such as recruitment rates and data collection, and ensure key milestones are being met
ensure the integrity and quality of the data being collected.

TSC members should have scientific, medical, and clinical trial management expertise to conduct and evaluate the trial effectively. At least 50% of TSC members (including the Chair) should be independent of the study.

A TSC should include:

an independent Chair
two independent members who have expertise relating to the scientific and medical nature and methodological procedures of the trial
a consumer representative
the Principal Investigator
one or two senior trial staff members, such as a Co-Investigator or trial statistician
a representative of the sponsor
expert observer (e.g. trial manager).

A TSC meeting should be held at least once before the start of the trial and, thereafter, at least annually. Meeting papers should be provided at least one week before the meeting, and accurate notes should be taken and documented. No unblinded information should be presented to the TSC unless advised by the Data Safety and Monitoring Board (DSMB).

Data Safety Monitoring Board (DSMB)

The DSMB monitors progress, ensures the integrity of data, and ensures the safety of the participants. Its role is to provide advice on safety and trial conduct to the sponsor, and to the TSC on whether to continue, modify or stop a trial.

The DSMB has access to unblinded and comparative data, allowing them to complete a more comprehensive review. A DSMB may not be required for all trials and is more commonly used with later-phase trials.

The main responsibilities of the DSMB are to:

regularly review the safety data, such as adverse events, to protect participants from undue harm
check the data collection and reporting for consistency and accuracy
conduct interim data analysis of the data to assess interventions, efficacy and safety to determine if the trial should continue
making recommendations to the TSC
unblind the data, when necessary, to make informed decisions about participant safety and trial conduct.