NCI Trial Eligibility Templates Are Here
One year ago, ASCO and Friends of Cancer Research published a series of special papers on clinical trial eligibility. Their original goal: “Identify specific criteria most likely to restrict patients’ participation in trials and those least likely to impact the safety of study participants.” Ultimately they aimed to “…broaden eligibility and enable recruitment of a trial population more representative of the intended users of the intervention being studied.” I think they did an astonishing job.
Now, the recommendations are becoming reality. Last week, the National Cancer Institute released new eligibility criteria template language for use in network trials. CTEP-run protocols being reviewed November 1 or after must use the new criteria. There remains appropriate flexibility; when specific criteria might pose special safety concerns, investigators may supply medical and scientific rationale for why the template language needs modification. You can find the new NCI templates here.
To make their recommendations, ASCO and Friends formed working groups made up of patient advocates, oncologists, drug and biotech manufacturers, and FDA regulators. They arrived at a consensus on broadening eligibility in five categories:
- Patients with brain metastases
- Patients with HIV/AIDS
- Patients with organ dysfunction
- Patients with prior or current malignancies
- Patients under the age of 18
The NCI assembled a similarly cross-cutting group to turn those recommendations into formal templates for use in clinical trial development. Staff from the Division of Cancer Treatment, the Division of Cancer Prevention, the Office of Cancer Centers, the Center for Cancer Research, the Coordinating Center for Clinical Trials, and the Investigational Drug Steering Committee Pharmacology Task Force reviewed the recommendations and came up with template language.
The release of the NCI templates is well timed for SWOG investigators. We had already planned to have Dr. Paul Hesketh, a lung investigator and a member of our Board of Governors, update us on the ASCO-Friends process at our general plenary next week in Chicago. We also scheduled a discussion on implementation at the semi-annual meeting committee chairs’ meeting, to get guidance on SWOG-specific uptake. After that meeting, Dana Sparks, our operations chief, will develop a rollout plan.
If you have comments or questions related to these new criteria, or the NCI templates themselves, send an email to APVPGRCPbzzragf/ng/znvy/qbg/avu/qbg/tbi And join us at Plenary II, so you can hear more from Paul. When we have a plan in place for SWOG, I’ll report on it right back here.
See you in Chicago!