Effective_Trial_Management_Flashcards

Overview

• Effective Clinical Trial Management

  • Delivered on: 13-March-25

  • Presenter: Dr. Jemima Thompson, UCL

Learning Outcomes

• Gain an overview of clinical trial conduct activities.

• Understand the importance of patient adherence and retention in clinical trials.

The Clinical Trials Toolkit - Routemap

• Key Components of Clinical Trials:

  • Peer Review

  • R&D Consultation

  • Trial Planning & Design

  • Risk Assessment

  • Sponsorship

  • Protocol Development

  • CTA Submission

  • Trial Management & Monitoring

  • Safety Reporting

• Documentation and Oversight:

  • Final Trial Management Documentation

  • Trial Master File

  • Final Protocol

  • Ethics Submission

  • Trial Documentation and Supplies

  • Urgent Safety Measures and Audit Documentation

Trial Conduct Activities

• Monitoring Key Aspects:

  • Participant accrual and safety

  • Compliance with the protocol and ICH GCP

  • Quality data collection

  • Addressing day-to-day queries

  • Reporting to oversight committees

Participant Accrual

• Understanding Accrual:

  • Process of enrolling participants into a clinical trial.

Planning for Optimal Accrual

• Strategies should be in place to maximize participant enrollment.

Adherence and Retention

• Significance:

  • Maintaining participant compliance with interventions and follow-up schedules.

• Activities:

  • Ensure adherence and retention strategies are implemented.

What is Adherence?

• Definition: The act of following treatment protocols as prescribed.

  • Adage: "Medicines work in those who can take them."

What is Retention?

• Definition: Keeping participants involved in the trial across its duration.

Importance of Adherence and Retention

• Trials aim to address specific questions about interventions:

  • Non-adherence can compromise data quality and outcome validity.

Reasons for Poor Adherence

• Participant challenges with treatment compliance—akin to personal habits like New Year’s resolutions.

Issues with Poor Retention

• Consequences include:

  • Incomplete data sets

  • Loss of study outcomes

  • Inconclusive results

Addressing Patient Retention

• Some dropout reasons can be mitigated through better study design and consideration of participant burden.

Common Factors Affecting Retention

• Factors such as treatment complexity, side effects, and logistical challenges impact retention.

Strategies to Improve Retention

• Pre-Trial:

  • Assess risks and create mitigation strategies.

  • Understand population needs via literature reviews.

  • Train site staff on retention importance.

• During Trial Conduct:

  • Initiate conversations about retention during consent.

  • Monitor retention continuously and intervene if necessary.

  • Engage patients and the public in discussions about trial issues.

Monitoring in Clinical Trials

• Definition: Overseeing trial progress and ensuring compliance with protocols and regulatory criteria.

• Importance:

  • Rights of participants are upheld.

  • Trial results must be accurate and verifiable.

Methods of Monitoring

• Can be performed centrally or on-site with a structured, risk-based approach.

Audits and Inspections

• Audits: Independent evaluations to ensure compliance with protocols and regulatory standards.

• Inspections: Regulatory authority reviews of trial-related documents and processes.

Role of Oversight Committees

• Independent committees facilitate effective trial governance and decision-making throughout the study.

Trial Management Group (TMG)

• Members Include:

  • Chief Investigator, Clinicians, Trial Managers, Statisticians

• Functions Include:

  • Research question agreement, trial design input, oversight during the study.

Data Monitoring Committees (IDMC)

• Functions to assess trial safety, efficacy, and suggest trial continuation or modification.

Trial Steering Committees (TSC)

• Provide independent oversight for large multicenter trials; ensure trial integrity.

Endpoint Review Committees

• Ensures unbiased assessment of complex trial endpoints.

Conclusion: Importance of Oversight Groups

• Ensures accountability, transparency, and independent review for robust scientific integrity in clinical trials.