What is Randomisation and Trial Supply Management (RTSM)?
Jennifer Ross
CT PA Director of Biostatistics
Kevin Venner
Group Leader, Biostatisticians
What is Randomisation and Trial Supply Management (RTSM)?
Randomisation and Trial Supply Management (RTSM) is another terminology for Interactive Response Technology (IRT). This nomenclature is specifically calling out the main functions and utilities of IRT. This term is becoming more popular in its use since it is industry specific for clinical trials. Almac Clinical Technologies’ RTSM / IRT platform is IXRS®3.
For more details on IRT, check out:
What is IRT and How Does it Impact Clinical Trials?
RTSM for Clinical Trials
The “R” in RTSM is randomisation (a primary utility of RTSM systems). Randomisation is the process for how patients are assigned to Treatments in a clinical trial with introducing a deliberate element of chance.
Randomisation in clinical trials:
- Provides a sound statistical basis for evaluation of treatment effects
- Balances treatment assignments
- Ensures patients are similar in respect to known / unknown confounding factors
- Protects study from selection bias
RTSM enables the global execution of randomisation across multiple sites in clinical trials. This removes the need for site-specific code envelopes and other burdensome manual randomisation processes.
What Types of Randomisation Methodologies are included in RTSM?
The type of randomisation methodology included in an RTSM system depends on the design specified within the protocol. Randomisation methodologies can vary from simple / standard to complex / highly customized.
For more information on:
- Standard randomisation methodologies implemented in RTSM, click here.
- Complex innovative designs impacting randomisation, click here.
How is Patient Randomisation implemented within the RTSM?
Determining how to implement randomisation first begins with the RTSM design team reviewing the protocol and identifying the type of randomisation methodology. The most common methodologies require a randomisation List (also referred to as Schedule or Scheme). On occasion, the protocol’s design may require alternative algorithmic approaches (such as Minimization).
Based on the protocol review and assessment of the randomisation methodology, the RTSM experts draft the system’s specifications. This includes a document detailing the requirements for the RTSM system, as well as a separate document for the randomisation List or Algorithm. The appropriate Sponsor / Study team designees then review and confirm that these specifications meet the protocol’s expectations.
In following the finalized specifications, the RTSM development team programs the system with utilizing dummy randomisation List or Algorithm data. The programmed functionality is thoroughly tested and validated by the RTSM testing team. Upon test validation completion, the RTSM system goes through User Acceptance Testing (by the RTSM team and Sponsor team) and QA certification. Finally, once certified, the RTSM system is ready go live!
Who creates the Patient Randomisation List for the RTSM?
The randomisation List is created by a representative with the appropriate qualifications. This person is usually a Biostatistician who has proficiency in randomisation, RTSM randomisation functionality and statistical software coding. Some Sponsors may have an in-house team responsible for creating randomisation Lists. Other Sponsors may prefer to contract out to qualified vendors or third parties.
Almac’s Biostatisticians are uniquely qualified to generate randomisation Lists since they are 100% dedicated to randomisation and RTSM implementation / support. They generate randomisation Lists with considering best RTSM implementation practices and provide recommendations (e.g., format, parameters) based on extensive experience.
Types of randomisation lists generated for RTSM utilization may include:
- Central / Stratified / Cohorts / Phases
- Fixed block sizes / Variable block sizes
- Maximum Tolerated Imbalance (MTI)
- Replacement Randomisation / Re-Randomisation / Multi-Step Randomisation
- Adaptive Designs / Complex Innovative Designs / Master Protocols
Almac Biostatistics group has a well-defined process for both randomisation List generation and Algorithm implementation to meet any protocol’s randomisation design needs. This includes randomisation List or Algorithm specification documentation, generation of Dummy / Live lists via SAS statistical software programming, generation of List Structure Reports (for ease of review / verification), List or Algorithm verification, and facilitation of sponsor designee approval.
Who imports the Patient Randomisation List into the RTSM?
The import of the randomisation List into the RTSM system is typically done by a representative within the RTSM organization. This representative should encompass adept knowledge in randomisation List structure and RTSM randomisation functionality to ensure the list’s compatibility with the system and successful import.
Almac has a team of Biostatistics Data Managers who are responsible for importing randomisation List(s) in each study. Almac’s Biostatistics group has a robust process for the data management and IXRS import of all lists which ensures high confidentiality / security and import compatibility / accuracy. All randomisation List RTSM imports at Almac are thoroughly reviewed and documented to provide the highest quality.
Randomisation and Trial Supply Management Summary
Randomisation is an essential component of clinical trials and is considered critical to the reliability of the trial’s results. Due to the high stakes of randomisation, the RTSM system should be developed by a RTSM company who has high level of knowledge / experience that Sponsors can entrust. With the RTSM team, along with the Biostatistics group of Biostatisticians and Data Managers, Almac has the necessary attributes to effectively implement randomisation with the highest quality.
Are you also curious about the “TSM” in RTSM?
The “TSM” in RTSM is Trial Supply Management. As an RTSM provider, Almac also exhibits expertise within this area. Check out the following for more information:
- Improve your Clinical Supply Chain Management Using IRT
- Streamlining Clinical Trial Supply Management and Reporting with Drug Pooling in the IRT World
- Elevating Study Experience in Decentralised Clinical Trials: How IRT Can Help
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