Report on a Delphi Process and Workshop to Improve Accrual to Cancer Clinical Trials

Abstract

Cancer clinical trials (ccts) are essential for furthering knowledge and developing effective interventions to improve the lives of people living with cancer in Canada. Randomized controlled trials are particularly important for developing evidence-based health care interventions. To produce robust and relevant research conclusions, timely and sufficient accrual to ccts is essential.The present report delivers the key recommendations emerging from a workshop meeting, Improve Accrual to Cancer Clinical Trials, that was hosted by the Canadian Cancer Trials Group and funded by the Canadian Institutes of Health Research. The meeting, which took place in Toronto, Ontario, in April 2012 before the Canadian Cancer Trials Group annual spring meeting, brought together key stakeholders from across Canada to explore creative strategies for improving accrual to ccts. The objectives of the workshop were to provide an opportunity for knowledge exchange with respect to the research evidence and the ethics theory related to cct accrual and to promote discussion of best practices and policies related to enhancing cct access and accrual in Canada.The workshop provided the foundation for establishing new interdisciplinary research collaborations to overcome the identified barriers to cct participation in Canada. Meeting participants also supported the development of evidence-based policies and practices to make trials more accessible to Canadians living with cancer.

Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study

“…However, less than 5% of adult patients with cancer participate in CTs [ 1 ] and many trials suffer from insufficient accrual, with earlier phase trial being especially problematic [ 2 ]. Poor accrual and retention have been linked to complex and lengthy consent procedures, which may create difficulties for patients in providing informed consent [ 3 , 4 ]. A systematic review evaluating patient understanding of consent for participation in CTs concluded that patients often do not fully understand the potential health risks of novel experimental drugs and have unrealistic expectations of benefit [ 5 ].…”

Gatekeeping in cancer clinical trials in Canada: The ethics of recruiting the “ideal” patient

“…36 To address the structural issue of limited time and CT resources, a recent report identified the need for streamlined accrual strategies and trials designed to balance feasibility, accessibility, and scientific opportunity. 37 For example, pragmatic CTs that compare effectiveness of treatment alternatives in real-world settings and include representation from diverse patient populations have been one trial design proposed to simplify and improve the accrual process. 27,38 Streamlining written informed consent documents has also become a focus of global effort to ensure more meaningful and efficient consent procedures within trials.…”