The LCTC has highly skilled and experienced trial management staff with extensive expertise in managing and supporting trials from inception to closure. This includes working in close collaboration with Chief Investigators (CIs) and sponsors to facilitate the preparation of funding applications, including costings, and contributing to trial design and methodology, coordinating protocol development and providing trial management and monitoring oversight throughout a study’s duration.

Each trial will have a designated lead for trial management and an appointed trial manager who acts as the central hub for trial communication and coordination in close liaison with the CI. The trial manager, on behalf of sponsor/s, will usually coordinate the completion and submission of applications to obtain regulatory approvals and ensures that all appropriate arrangements are in place in compliance with the regulatory green light process for trial opening.

The trial manager works closely with Research and Development (R & D) departments and research teams in recruiting sites to facilitate their progress through site opening procedures, assisting with any issues during setup, recruitment and through to closure and archiving, building rapport through effective communication so that site engagement is optimised.

Statisticians within the LCTC play a key role in the design and planning of phase I - IV randomised controlled trials and other well-designed studies. We ensure that the most efficient and appropriate designs are used in compliance with necessary legislative frameworks. We also have input into all types of studies including feasibility studies, pilot studies, core outcome sets and other research. Statisticians will contribute to ensuring that study objectives are met, defining study outcomes, mitigating for any potential sources of bias, performing power calculations to determine the sample size and ensuring appropriate methods of randomisation, blinding, data capture and analysis are applied.

Throughout the course of the trial the statistics team will produce regular trial reports to both trial management groups and independent oversight committees and contribute to the data cleaning and monitoring activities with other members of the trial team.

The final analysis of the trial will be conducted following the pre-defined statistical analysis plan developed by the statistical team and will use methodological research relevant to the design of the trial. Statisticians contribute to the final study publication and report and are key collaborators during the course of the trial.

LCTC Monitoring allows us to oversee the progress of a clinical trial and ensure that it is conducted, recorded and reported in accordance with the trial protocol, Standard Operating Procedures (SOPs), GCP and the applicable regulatory requirements. The determination of the extent and nature of onsite and central monitoring conducted is based on a number of considerations such as the objective, purpose, design, complexity, blinding, size, endpoints and risks of the trial.

The purpose of our monitoring is to:

• Ensure protection of the safety, rights and well-being of the subjects participating in the LCTC studies.
• Improve the quality of data captured and promoting high standards to enhance data integrity.
• Verify that a trial is being conducted in compliance with the currently approved protocol/amendments(s), GCP principles and the applicable regulatory requirements.
• Build confidence and cultivate trust while working with the sponsor and site staff.
• Think critically to resolve issues and achieve the monitoring goals which aim to verify the ongoing quality of a trial.