Risk-assessment approach outlined for biomarker-driven clinical trials

Share this content:

A practical risk-management approach for effectively integrating biomarkers into cancer clinical trials has been outlined by a working group with members from the US National Cancer Institute (NCI), the United Kingdom National Cancer Research Institute (NCRI), and the European Organisation for Research and Treatment of Cancer (EORTC).

Their work provides the international community with a set of common principles by which biomarkers can be integrated into clinical trials, exchange of data can be facilitated, quality promoted, and research accelerated. Also, it simultaneously respects local approaches and legislation. The approach from this working group was published in The Lancet Oncology (2014; doi:10.1016/S1470-2045(13)70607-7).

Their risk-assessment approach for designing and conducting cancer clinical trials includes risks to patient safety, operational risks, and biomarker development risks. For each risk, they evaluated possible consequences and provided solutions along with examples of these. They also provided references to helpful resources.

Concerning protocol design, the working group recommended items that a protocol should include as well as items that should be assessed during protocol development. For the conduct of the trial, they made recommendations for the close monitoring of variability in test results, and they also made recommendations for particular aspects following completion of the trial.

Dr. Jacqueline Hall, who coordinated this NCI, NCRI, and EORTC working group said, “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.”

The group explained that their publication outlines a consensus framework. It uses a novel and practical risk-assessment approach that can be used internationally. Their hope is that biomarkers will ultimately be developed that can readily be integrated into routine practice.

You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs