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Guidelines Proposed for Complex Clinical Trials

Chemotherapy vials

Chemotherapy vials (National Cancer Institute, NIH)

6 Jan. 2020. A working group published guidelines for conducting clinical trials that simultaneously test multiple cancer treatments and can change course over time. The proposals from a panel of the Experimental Cancer Medicine Centre in London, appear in today’s issue of the British Journal of Cancer.

The recommendations cover the planning, recruitment, conduct, reporting of results, and evaluation of what the working group calls complex innovative design clinical trials. These studies use a single overall design that allows for tests of treatments addressing genetic mutations suspected of causing one or more types of cancer. In addition, these single protocols make it possible to change the trial design over time as results are reported.

As a result, complex innovative design clinical trials are considered promising tools for faster and more economical testing of new treatments. Yet up to now, no comprehensive guidelines were offered for conducting these new types of trials. The working group from the Experimental Cancer Medicine Centre that prepared the recommendations is made up of academic researchers, clinicians, regulators, and pharmaceutical company representatives. The Centre held workshops in the U.K. beginning in 2017 to frame the issues and write the proposed guidelines.

The group recommends ..

  1. Plan the complex clinical trial with all parties, including regulators and assessment specialists, particularly if the sponsors plan to request accelerated review of the results.
  2. Develop a detailed design protocol incorporating all anticipated modifications and defining events that indicate completion of the study.
  3. Generate training and support for participants, with education for the public and accreditation if needed about the trial.
  4. Prepare documentation for participants, including invitations, instructions for the arms or testing groups in which they take part, and a reference handbook.
  5. Assemble the statistical expertise and systems needed to conduct the trial, with tools and tests identified for incorporating changes in the study as it proceeds, including variations to accommodate new treatments or molecular characteristics, and even additional diseases.
  6. Recruit a management group to oversee conduct of the trial, with new investigators brought on as the study evolves.
  7. Report and disseminate findings from the study at predefined time points, and as the trial’s test groups are completed.
  8. Conduct training in complex innovative design trials for staff assigned to the study, and within curricula to prepare new health care professionals.
  9. Structure regulatory reviews and financial reimbursements to reflect the faster reporting of results from complex innovative design, or CID, trials.
  10. Conduct an impact analysis for these new type of trials to assess their faster delivery of results, while assuring patient safety.

“We owe it to our patients,” says Pamela Kearns, one of the authors and director of the clinical trials unit at University of Birmingham, in a Cancer Research UK statement, “to bring potentially more effective novel treatments into the clinic as quickly as possible, and these recommendations will ensure we have good quality CID trials in place to deliver this promise.” Cancer Research UK and National Institute of Health Research are funders of the Experimental Cancer Medicine Centre, with health departments in Scotland, Wales, and Northern Ireland.

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