One of Dr. Monica Bertagnolli's key initiatives as director of the National Cancer Institute has been the creation of the Clinical Trials Innovation Unit (CTIU). Although it's still a work in progress, the CTIU is now accepting its first round of project proposals, with a June 12th deadline. I'm sure it's no surprise, but the SWOG committee chairs seem to be full up with ideas to submit.

The unit is not directly part of the NCTN or the NCORP, but instead is a parallel mechanism for getting innovative projects done more quickly. The unit’s new web page does specify that CTIU trials will be conducted within the NCTN framework, with streamlined evaluation and activation processes.

Dr. Bertagnolli has herself described the CTIU as a collaboration between the NCI, the FDA, and the extramural cancer clinical research community. She has said it’s intended to tackle scientific questions that are amenable to radically new study designs and operational procedures – anything that can help the NCI engage more broadly and deliver results faster.

Dr. Michael Morris, the unit’s co-director (with Dr. Sheila Prindiville of the NCI), introduced our committee chairs to the CTIU in San Francisco last week. On Wednesday, I sent a follow-up message to chairs detailing the process and timeline SWOG will follow in selecting the proposals we’ll submit for the round one deadline.

In brief, proposals (primarily therapeutic, for this round) are due to our protocol department May 23rd. Our executive officers will vet concepts and bring them to the executive advisory committee late next week for discussion and ranking. We’ll select the best of the best to submit to CTIU.

What is the CTIU looking for in a proposal? A key element is a clear and convincing argument for why the trial should be done through the CTIU, rather than more conventional mechanisms.

The NCI plans a quick internal review process and expects to announce their selection(s) for the first round of CTIU trials sometime in July. If SWOG is assigned one or more trials, they will immediately become our top priority for rapid protocol development and activation, in much the same way as the recent S2302 Pragmatica-Lung study.

In fact, S2302 Pragmatica-Lung is a good example for the type of projects that may come out of CTIU. We know we can produce finished protocols for radically new designs and do so at near-record speed, because we’ve just done it. Of course, we also know the degree of work required to achieve this!

But we’ve already made history at least a couple of times this year – with the activation of S2302, with the election of our first group co-chairs-elect …. Why stop there?