Canadian Cancer Trials Group Bulletins

General


Canadian Cancer Trials Group Strategic Retreat

On October 24-26, 2008, members of the Canadian Cancer Trials Group gathered for a Strategic Retreat to discuss past successes and the issues and challenges that face the Group in the coming years.

Over 160 people attended. We would like to thank everyone who was able to join us and for their thoughtful discussion and insights. In particular, we would like to heartily thank each of the presenters on Friday, the chairs who led the breakout sessions, and the rapporteurs who so competently reported back to the group. We are grateful for all of your hard work.

Our plan is to compile the information collected during the Retreat, synthesize it, and have it interpreted and acted on by our scientific and operational committees. We will then summarize conclusions for all Canadian Cancer Trials Group members and use this information as our foundation for building strategic and operational plans that will take us through the future.

BACKGROUND FOR THE RETREAT
Over the past decade, there have been substantial changes in the scientific directions and conduct of cancer clinical trials, including those conducted by the Canadian Cancer Trials Group. Among these changes are:

1. New understandings of the basic molecular mechanisms of cancer that have increased the ability to test interventions that directly and more specifically alter these mechanisms.

2. New understandings of the basic molecular mechanism of cancer that have resulted in increasing numbers of trials conducted by industry or by cooperative groups in collaboration with industry.

3. Changing expectations associated with phase III trials including:
  • Inclusion of specialized populations based on risk categorization, biologic/molecular profiling and/or histologic sub-classifications.

  • Trials designed to detect smaller clinically important differences that require larger sample sizes.

  • Societal expecations to provide answers sooner.

To meet these requirements, trials must be increasingly global and involve participation of multiple cooperative groups. Informatics systems exist to facilitate the collaborative conduct of such trials.

4. Increased expectations that clinical trials include evaluation of complex secondary outcomes, including quality of life, economic parameters, and correlative biology.

5. Increased complexity of trial conduct over the past 10-20 years resulting from changes in the clinical research regulatory environment (e.g., International Harmonization Conference Good Clinical Practice or GCP), and by the potential use of clinical trials data as submissions to regulatory agencies for New Drug Approval (NDA).

6. Increased complexity of clinical trials operations at health care institutions involving higher degrees of management and financial accountability.

7. Increased desire of research organizations to participate in the determination of strategic directions and accountability of research payback.

Due to these changes, and given that the Canadian Cancer Trials Group is entering the final year of this NCIC funding cycle, it seemed an appropriate time for the Canadian Cancer Trials Group to begin the process of evaluating its scientific priorities and operational processes. This Retreat was the first step in that evaluation.

THE RETREAT
The primary objective of the Retreat was to provide a forum for discussion around the evolution and development of Canadian Cancer Trials Group's strategic agenda, and the ability of its Central Office and member institutions to implement this agenda. The second, but very important, objective was to promote communication among investigators, and between investigators and the Canadian Cancer Trials Group Central Office.

Participants included members from our Disease Site Committee Executives, including IND Exec and representatives from the Head and Neck Working Group, the Centre Rep Executive Committee, Clinical Trials Committee, Data Safety Monitoring Committee, Clinical Research Associ onomic Analysis, Quality of Life Committee, Psychosocial Research Working Group, Correlative Sciences/Tumour Biology Committee, and the Audit and Monitoring Committee. Representation was national.

The first day (Friday afternoon / evening Oct 24) included a single large group session that set the stage and provided background. The second day (Sat Oct 25) was divided into two portions: the first half included simultaneous breakout sessions that addressed a series of topics; the second half involved a reporting-back process. The third day (Sun Oct 26) involved the standard Site Executive meetings

Friday Agenda

Session #1 -- Creating a Scientific Agenda:

The Successful Trial - CO.17 Derek Jonker, Study Chair
The Successful Site Committee - Lung Frances Shepherd, Past Chair, Lung Site Committee
CTEP Strategic Priorities and Roll-out Meg Mooney, CTEP

Session #2: Clinical Trials at a Centre Level

Determining a Centre Portfolio Kim Chi, Centre Rep, Vancouver
Selecting and Activating Canadian Cancer Trials Group Trials Katia Tonkin, Centre Rep, Edmonton
Conducting Canadian Cancer Trials Group Trials Brenda Kowaleski, Hamilton

Session #3: Interacting with the Canadian Cancer Trials Group Central Office

Developing and Activating a Trial Elizabeth Eisenhauer, Canadian Cancer Trials Group
Quality Data and Conduct Lesley Seymour, Canadian Cancer Trials Group

Activating & Opening Oncology Clinical Trials David Dilts, Nashville, TN


Saturday Agenda

Each Breakout Session was chaired by a senior Canadian Cancer Trials Group investigator who led and facilitated discussions and ensured broad participation. Each session was also assigned a rapporteur who was responsible for noting and describing topics discussed, including variations in opinion and priorities. Central Office support to each session included an Canadian Cancer Trials Group faculty member and/or senior manager, and a study coordinator. Most committees included a CRA, pharmacist, and lay representative. There were approximately 15-20 participants assigned to each session to ensure, as much as possible, balance by Canadian Cancer Trials Group committee, discipline, seniority and geographic centre.

A debriefing and discussion session for reporting back to all retreat attendees was held. Rapporteurs were asked to report the nature of discussions from their session which was followed by an opportunity for broad discussion.

Breakouts

Scientific Program:
Session 1 How does the Canadian Cancer Trials Group best position itself in an international environment?
Chair: Tony Fields
Rapporteur: Stephen Couban

Session 2 How should the Canadian Cancer Trials Group evaluate its scope given that there are 11 Disease
Site Committees that include more than 25 Working Groups?
Chair: Mary Gospodarowicz
Rapporteur: Bernie Cummings

Session 3 How does Canadian Cancer Trials Group best collaborate with industry in conducting clinical trials?
Chair: Vivien Bramwell
Rapporteur: Stephen Chia

Session 4 Where in our strategic priorities should we place trials that do not include new drug approval processes?
Chair: Rebecca Wong
Rapporteur: Tom Pickles

Session 5 How do we insert hypothesis-based correlative research into our trials?
Chair: Ann Chambers
Rapporteur: Sharlene Gill

Session 6 How do we develop, evaluate and approve concepts and take these to a stage of trial activation?
Chair: Eric Winquist
Rapporteur: John Waldron

Operational Processes:
Session 7 How can aspects of trial conduct be improved?
Chair: Joe Connors
Rapporteur: Isabelle Gauthier

Session 8 How can Canadian Cancer Trials Group better interact with its centres?
Chair: Peter Craighead
Rapporteur: Susan Dent

Session 9 What are the barriers to accrual and how do we address these?
Chair: Jim Wright
Rapporteur: Bernie Eigl

A website will be set up by Canadian Cancer Trials Group to provide slide presentations and summary documents. We will let you know when it's available.