Growing interest in integrated research platform trials (IRPs) – studies designed to evaluate multiple therapies simultaneously – is making drug research more complex say authors of new study calling for greater regulatory flexibility.
The study – by scientists working on the EU-PEARL initiative – found that although current GCP guidelines are effective for relatively simple, single product trials, for multi-drug trials greater flexibility is required.
“Complexity occurs in two dimensions in platform clinical trials: the protocol and the operations. Trials that are complex in any one of these dimensions require special flexibility to easily adapt to variability and change, including in the technologies built to support the trial.”
“IRP protocol complexity covers specifics in the study design and can be related to the treatment, patient flow through the study, and point-in-time complexities. Protocol complexities might include multiple treatment arms, variable visit schedules, or personalized medicines,” they write.
The authors point out that because the concept of IRPs is relatively new in clinical development regulators have only recently started to develop guidelines on challenges like safety oversight of the trials, data transparency and integrity, and control of type one errors.
Template
To that end the authors developed a series of generic template documents that are designed to help sponsors and contract research organizations (CROs) maintain compliance with good clinical practice (GCP), while affording the extra flexibility that IRBs require.
“The suite of templates for IRPs based on TransCelerate’s Common Protocol Template (CPT) and statistical analysis plan (SAP) should help authors navigate relevant guidelines as they create study design content relevant for today’s IRP studies.
“It offers practical suggestions for adaptive platform designs which offer flexible features such as dropping treatments for futility or adding new treatments to be tested during a trial,” the authors write.
The team has also developed a platform trials best practices tool to support the setup, design, planning, implementation, and conduct of complex and innovative trials to support multi-sourced/multi-company platform trials.
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