Harnessing imaging tools to guide immunotherapy trials: summary from the National Cancer Institute Cancer Imaging Steering Committee workshop.

As the immuno-oncology field continues the rapid growth witnessed over the past decade, optimising patient outcomes requires an evolution in the current response-assessment guidelines for phase 2 and 3 immunotherapy clinical trials and clinical care. Additionally, investigational tools-including image analysis of standard-of-care scans (such as CT, magnetic resonance, and PET) with analytics, such as radiomics, functional magnetic resonance agents, and novel molecular-imaging PET agents-offer promising advancements for assessment of immunotherapy. To document current challenges and opportunities and identify next steps in immunotherapy diagnostic imaging, the National Cancer Institute Clinical Imaging Steering Committee convened a meeting with diverse representation among imaging experts and oncologists to generate a comprehensive review of the state of the field.

Considerations on Integrating Prostate-Specific Membrane Antigen Positron Emission Tomography Imaging Into Clinical Prostate Cancer Trials by National Clinical Trials Network Cooperative Groups.

PURPOSE: As prostate-specific membrane antigen (PSMA) positron emission tomography (PET) becomes increasingly available in the United States, the greater sensitivity of the technology in comparison to conventional imaging poses challenges for clinical trials. The NCI Clinical Imaging Steering Committee (CISC) PSMA PET Working Group was convened to coordinate the identification of these challenges in various clinical scenarios and to develop consensus recommendations on how best to integrate PSMA PET into ongoing and upcoming National Clinical Trials Network (NCTN) trials. METHODS: NCI CISC and NCI Genitourinary Steering Committee members and leadership nominated clinicians, biostatisticians, patient advocates, and other imaging experts for inclusion in the PSMA PET Working Group. From April to July 2021, the working group met independently and in conjunction with the CISC to frame challenges, including stage migration, response assessment, trial logistics, and statistical challenges, and to discuss proposed solutions. An anonymous, open-ended survey was distributed to members to collect feedback on challenges faced. Representatives from each NCTN group were invited to present an overview of affected trials. From these discussions, the consensus document was developed and circulated for the inclusion of multiple rounds of feedback from both the Working Group and CISC. RESULTS: The current consensus document outlines the key challenges for clinical prostate cancer trials resulting from the increasing availability of PSMA PET. We discuss implications for patient selection and definition of end points and provide guidance and potential solutions for different clinical scenarios, particularly with regard to best practices in defining eligibility criteria and outcome measures. RECOMMENDATIONS: This article provides guidance regarding clinical trial design and conduct, and the interpretation of trial results.

America COMPETES at 5 years: An Analysis of Research-Intensive Universities' RCR Training Plans.

This project evaluates the impact of the National Science Foundation's (NSF) policy to promote education in the responsible conduct of research (RCR). To determine whether this policy resulted in meaningful RCR educational experiences, our study examined the instructional plans developed by individual universities in response to the mandate. Using a sample of 108 U.S. institutions classified as Carnegie "very high research activity", we analyzed all publicly available NSF RCR training plans in light of the consensus best practices in RCR education that were known at the time the policy was implemented. We found that fewer than half of universities developed plans that incorporated at least some of the best practices. More specifically, only 31% of universities had content and requirements that differed by career stage, only 1% of universities had content and requirements that differed by discipline; and only 18% of universities required some face-to-face engagement from all classes of trainees. Indeed, some schools simply provided hand-outs to their undergraduate students. Most universities (82%) had plans that could be satisfied with online programs such as the Collaborative Institutional Training Initiative's RCR modules. The NSF policy requires universities to develop RCR training plans, but provides no guidelines or requirements for the format, scope, content, duration, or frequency of the training, and does not hold universities accountable for their training plans. Our study shows that this vaguely worded policy, and lack of accountability, has not produced meaningful educational experiences for most of the undergraduate students, graduate students, and post-doctoral trainees funded by the NSF.