E-News - October 2024
Spotlight on Publications

 

Alliance Group Statistician Co-Chairs Working Group Whose Recommendations Define a "New Normal" for Data Collection and Published in the Journal of the National Cancer Institute

The Journal of the National Cancer Institute has published ‘Streamlining the Conduct of Cancer Clinical Trials: New Standard Data Collection Practices for National Cancer Institute Late Phase Clinical Studies,’ which assesses the impact of the stressors on the National Cancer Institute (NCI) National Clinical Trials Network (NCTN) and recommends that data collection in late phase NCTN trials be limited to data elements essential to address the primary and secondary objectives of the trial. 

The commentary describes the rationale for this recommendation, progress towards implementation, and the development of new streamlined standard practices for data collection for late phase NCTN trials effective January 1, 2025.

Background
In November 2020, the Clinical Trials and Translational Research Advisory Committee (CTAC) ad hoc Strategic Planning Working Group (SPWG) released its report, which envisioned the development of flexible, faster, simpler and less expensive high-impact clinical trials that seamlessly integrate with clinical practice.

In July 2021, in response to the urgent need to mitigate the operational burden of NCI-sponsored clinical trials without compromising trial objectives or patient safety, NCI convened the CTAC ad hoc Streamlining Clinical Trials Working Group to advise the NCI Director and CTAC. The working group was co-chaired by Sumithra Mandrekar, PhD, Professor of Biostatistics and Oncology (Mayo Clinic Comprehensive Cancer Center) and Group Statistician (Alliance for Clinical Trials in Oncology), and Neal Meropol, MD, Vice President of Research Oncology, Scientific and Clinical Lead, Clinical Research (Flatiron Health).

The working group developed a set of proposed standard practices for data collection for adult, late-phase, IND-exempt trials for recommendation to NCI. The proposed practices are intended to define a "new normal" for data collection that is less burdensome, more efficient and more sustainable. It is important to note that the practices are not intended to be applied rigidly at the cost of compromising key study objectives. A final report was approved at the CTAC meeting in March 2024. The publication, ‘Streamlining the Conduct of Cancer Clinical Trials: New Standard Data Collection Practices for National Cancer Institute Late Phase Clinical Studies,’ summarizing the key points was published on September 26, 2024, with Drs. Sheila Prindiville, Director, Coordinating Center for Clinical Trials (NCI), and Mandrekar as co-first authors. Click the link below to access the publication.

Sheila A Prindiville, Sumithra J Mandrekar, Neal J Meropol, Andrea Denicoff, Oren Grad, Judith A Hautala, James H Doroshow, Streamlining the Conduct of Cancer Clinical Trials: New Standard Data Collection Practices for National Cancer Institute Late Phase Clinical Studies, JNCI: Journal of the National Cancer Institute, 2024;, djae239, https://doi.org/10.1093/jnci/djae239