What Do Complex Innovative Designs Mean for Oncology Trial Conduct?

Posted by Heather Pitt on Jul 20, 2020 11:22:53 AM

The term Complex Innovative Design (CID) is used to collectively describe the modern master protocol approaches that have been taken so far in oncology clinical research. The emergence of CIDs highlights how the traditional phased clinical trial pathway for oncology trials is increasingly being overturned in favor of more innovative and efficient protocol designs that combine multiple clinical questions within a single study.

The main aim of a master protocol is to embed flexibility into the design of the trial and approaches to-date include:

  • Umbrella design: Patients with the same disease are recruited, their different genetic alterations are identified through testing, and different drugs are given to them according to their unique molecular characteristics. In this model, sponsors are able to investigate multiple target agents under the umbrella of one disease. Umbrella design trials often include multiple treatments and multiple biomarkers in the same study, allowing for randomized comparisons.
  • Basket design: Patients with the same genetic mutation are included regardless of their cancer type. In this design, the focus is on drug effectiveness on the target mutation as opposed to the type of tumor. This design is very useful if a sponsor wants to study a single targeted therapy in the context of multiple diseases or disease subtypes. Furthermore, it can help in the development and study of specific biomarkers in rare tumors.
  • Platform design: A “platform trial” is a clinical trial with a single master protocol in which multiple treatments are evaluated simultaneously. Adaptive platform designs offer flexible features such as dropping treatments for futility, declaring one or more treatments superior, or adding new treatments to be tested during the course of a trial.

 

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In January 2020, Complex Innovative Design (CID) trial recommendations were published in the British Journal of Cancer, with the objective of improving the conduct, quality and acceptability of oncology trials in clinical research, as well as to improve how different stakeholders interact, promote and share learnings from CID trials.

The publishing of these 10 recommendations draws on the experiences of multiple stakeholders who have already conducted oncology trials using a CID approach and discusses the issues encountered during trial conduct and subsequent recommendations for the areas of:

End of Study Results

  1. Trial planning and design
  2. Protocol development
  3. Patient and public involvement
  4. Patient-facing documentation
  5. Statistical considerations
  6. Defining leadership and oversight as part of trial conduct and delivery considerations
  7. Dissemination of results
  8. Staff training
  9. Approval and reimbursement decisions
  10. Evaluating the impact

Whilst CID trial designs will bring more targeted and improved oncology treatments through to market and potentially reduce costly trial failures, the recommendations highlight that this approach also brings increased operational complexity that must be carefully planned for and balanced at all stages of trial conduct.

From the site staff perspective, a CID trial requires clear and concise training on what to do at different stages of the study based on the adaptive trial design and what course of treatment individual patients may be following under the available options of the master protocol.

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From the patient perspective, consent discussions for a CID trial will likely require more time and additional supporting materials to ensure the patient is fully aware of what taking part would look like for them based on a variety of scenarios covered under the master protocol. 

Site staff need to be supported to address an increased number of questions from patients that will inevitably arise due to the complexity of the master protocols. Providing an even longer consent form is not the solution and so sponsors need to consider visual, video, and other formats to ensure the patient is truly informed.

Here at Longboat, we specialize in supporting all trial stakeholders (including site staff, patients & caregivers, and study teams) to compliantly and confidently conduct trials. If you are thinking about executing a CID study, talk to us about how we can streamline the conduct of your study with practical technology solutions that reduce the site and patient burden.

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Topics: clinical trial protocol training, Clinical Operations, Clinical Studies, Clinical trial protocols, Oncology Trials

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