text
text

Search the toolbox

Planning & Design

  • Patient Engagement

    Find resources to help integrate patient perspectives throughout the trial lifecycle, from shaping the research question to reporting and evaluation, including informed consent guidance and best practices for stakeholder collaboration.

  • Complex Innovative Design

    Find resources on master protocol designs to help you plan flexible, efficient, and patient-centric trials that assess multiple Investigative Medicinal Products (IMPs) or diseases, within a shared framework across sub-protocols.

Regulatory

  • European Regulations

    Access key guidelines and official documents on master protocols (EMA). 

  • Regulatory Challenges

    Discover regulatory challenges encountered  in real world master protocol trials, with insights to help you navigate them.

Statistics & Data Management

  • Data Management

    Get practical guidance for managing and monitoring data in flexible master protocol trials, from maintaining data quality across changing treatment arms to establishing oversight structures like data monitoring or steering committees.

  • Statistical Ressources

    Access resources to plan, design, and analyse complex master protocol trials using appropriate statistical approaches.

Trial Conduct

  • Trial Management

    Access practical resources on implementing and managing master protocol trials, including lessons learned, templates, and strategies for real-world challenges from trial conduct through close-out.

  • Safety/Pharmacovigilance

    Find guidance on patient safety, monitoring, and pharmacovigilance. Safety considerations in complex and master protocol trials follow the same principles as any other type of clinical trial.

  • Reporting

    Discover guidance to improve transparency and consistency when reporting master protocol trials — including best practices for registering, structuring, and disclosing results for individual substudies.

Results (105)

Complex Innovative Design

Find resources on master protocol designs to help you plan flexible, efficient, and patient-centric trials that assess multiple Investigative Medicinal Products (IMPs) or diseases, within a shared framework across sub-protocols.

No items
Content

What is it? 

This is a podcast series developed by NHS, Health Research Authority on Complex Innovative Designs. In this episode, Professor Pam Kearns, Professor of Clinical Paediatric Oncology, Director of the Cancer Research UK Clinical Trials Unit and Institute of Genomic Sciences in Birmingham explains what are Complex Innovative Designs and the difference in different trial methodologies, Basket, Umbrella, Multi Arm Multi Stage (MAMS) Trials. 
 

  • Planning & Design
  • Complex Innovative Design
Acces tool

What is it? 

This is a podcast series developed by NHS, Health Research Authority on Complex Innovative Designs. In this episode, Professor Pam Kearns, Professor of Clinical Paediatric Oncology, Director of the Cancer Research UK Clinical Trials Unit and Institute of Genomic Sciences in Birmingham explains what are Complex Innovative Designs and the difference in different trial methodologies, Basket, Umbrella, Multi Arm Multi Stage (MAMS) Trials. 
 

  • Planning & Design
  • Complex Innovative Design
Acces tool

What is it?

This is a white paper authored by Cytel experts on Data Monitoring Committees (DMCs) for oncology studies. It describes how DMCs safeguard the interests of patients by monitoring safety, efficacy, and study integrity in high-stakes cancer trials. The paper highlights oncology-specific challenges such as open-label studies, co-primary endpoints, interpretation of immature data, censoring, and the role of independent review committees.

How can it be useful?

The white paper provides practical guidance on DMC operations in oncology, including examples of statistical outputs (Kaplan–Meier, waterfall, spider, and volcano plots), handling adverse events, and rapid turnaround of interim analyses. It also discusses regulatory perspectives, firewalling of data, and special considerations in Phase 3 or platform/basket/umbrella oncology trials. This makes it a valuable reference for researchers, sponsors, and regulators planning or managing oncology studies with DMC oversight.

  • Trial Conduct
  • Safety/Pharmacovigilance
Acces tool

What is it?

This is a white paper authored by Cytel experts on Data Monitoring Committees (DMCs) for oncology studies. It describes how DMCs safeguard the interests of patients by monitoring safety, efficacy, and study integrity in high-stakes cancer trials. The paper highlights oncology-specific challenges such as open-label studies, co-primary endpoints, interpretation of immature data, censoring, and the role of independent review committees.

How can it be useful?

The white paper provides practical guidance on DMC operations in oncology, including examples of statistical outputs (Kaplan–Meier, waterfall, spider, and volcano plots), handling adverse events, and rapid turnaround of interim analyses. It also discusses regulatory perspectives, firewalling of data, and special considerations in Phase 3 or platform/basket/umbrella oncology trials. This makes it a valuable reference for researchers, sponsors, and regulators planning or managing oncology studies with DMC oversight.

  • Trial Conduct
  • Safety/Pharmacovigilance
Acces tool

What is it?

This is a white paper authored by Cytel experts on Data Monitoring Committees (DMCs) for oncology studies. It describes how DMCs safeguard the interests of patients by monitoring safety, efficacy, and study integrity in high-stakes cancer trials. The paper highlights oncology-specific challenges such as open-label studies, co-primary endpoints, interpretation of immature data, censoring, and the role of independent review committees.

How can it be useful?

The white paper provides practical guidance on DMC operations in oncology, including examples of statistical outputs (Kaplan–Meier, waterfall, spider, and volcano plots), handling adverse events, and rapid turnaround of interim analyses. It also discusses regulatory perspectives, firewalling of data, and special considerations in Phase 3 or platform/basket/umbrella oncology trials. This makes it a valuable reference for researchers, sponsors, and regulators planning or managing oncology studies with DMC oversight.

  • Trial Conduct
  • Safety/Pharmacovigilance
Acces tool