Their risk-assessment approach for designing and conducting cancer clinical trials include risks to patient safety, operational risks, and biomarker development risks, and for each risk they evaluate possible consequences, provide solutions along with examples of these as well as references to helpful resources. Concerning protocol design, the working group recommends items that a protocol should include as well as items that should be assessed during protocol development. For the conduct of the trial, they make recommendations for the close monitoring of variability in test results, and they also make recommendations for particular aspects following completion of the trial.
Dr. Jacqueline Hall, who coordinated this NCI, NCRI, and EORTC working group says, "We readily acknowledge that in today's clinical trial landscape, many stakeholders play a role in clinical trials. These include regulators, public authorities, and patients, amongst others. By opening this discussion to others, we hope to find solutions to the varied challenges facing molecularly driven clinical research."
Support for this research came from the EORTC Charitable Trust and the UK Department of Health’s National Institute for Health Research Biomedical Research Centres funding scheme.