Patient-Reported Outcomes Assessment in Cancer Trials (PROACT): Evaluating & Enhancing the Payoff to Decision-Making

On September 20 - 21, 2006, the National Cancer Institute (NCI) and the American Cancer Society (ACS) co-sponsored a conference entitled "Patient-Reported Outcomes Assessment in Cancer Trials (PROACT): Evaluating and Enhancing the Payoff to Decision-Making". During the 2 days, participants discussed what we know about the use and value of patient-reported outcomes, such as HRQOL, in clinical trials, identified the challenges to more frequent or extensive application, and identified the research studies and application projects that would enhance the decision relevance of HRQOL measurement in trials.

The 13 articles contained in this special issue of the Journal of Clinical Oncology provide a comprehensive summary of the discussions and recommendations from the PROACT conference. Taken together, the articles reflect a diversity of viewpoints, but also a shared sense of purpose regarding the importance of measuring cancer outcomes from the patient's perspective. Some articles provide descriptive information on the clinical trial infrastructure in NCI-supported, as well as US pharmaceutical industry-supported, trials that use PROs. Others elucidate the issues and opportunities for improving the planning, design, methods, and implementation of PROs in cancer clinical trials at all phases of development. Advancements in measuring PROs are also described. Additional perspective on PROs is provided by representatives from the Food and Drug Administration, the pharmaceutical industry, and from clinical trial researchers from Canada and Europe. The special issue ends with a paper that synthesizes the key themes that emerged across the papers and includes recommendations from conference attendees for improving future prioritization, administration, and conduct of NCI-supported clinical trials that use PROs.

Contents

• Patient-Reported Outcomes Assessment in Cancer Trials: Evaluating and Enhancing the Payoff to Decision Making. Steven B. Clauser, Patricia A. Ganz, Joseph Lipscomb, and Bryce B. Reeve
• Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute -- Sponsored Clinical Trials Networks. Deborah Watkins Bruner, Charlene J. Bryan, Neil Aaronson, C. Craig Blackmore, Michael Brundage, David Cella, Patricia A. Ganz, Carolyn Gotay, Pamela S. Hinds, Alice B. Kornblith, Benjamin Movsas, Jeff Sloan, Lari Wenzel, and Giles Whalen
• Patient-Reported Outcomes in Phase II Cancer Clinical Trials: Lessons Learned and Future Directions. Lynne I. Wagner, Lari Wenzel, Edward Shaw, and David Cella
• Use of Patient-Reported Outcomes in Phase III Cancer Treatment Trials: Lessons Learned and Future Directions. Patricia A. Ganz and Carolyn C. Gotay
• Integrating Patient-Reported Outcomes Into Cancer Symptom Management Clinical Trials Supported by the National Cancer Institute -- Sponsored Clinical Trials Networks. Jeff A. Sloan, Lawrence Berk, Joseph Roscoe, Michael J. Fisch, Edward G. Shaw, Gwen Wyatt, Gary R. Morrow, and Amylou C. Dueck
• Lessons Learned in the Assessment of Health-Related Quality of Life: Selected Examples From the National Cancer Institute of Canada Clinical Trials Group. Michael Brundage, David Osoba, Andrea Bezjak, Dongsheng Tu, Michael Palmer, and Joseph Pater
• International Perspective on Health-Related Quality-of-Life Research in Cancer Clinical Trials: The European Organisation for Research and Treatment of Cancer Experience. Andrew Bottomley and Neil K. Aaronson
• Current Status of Patient-Reported Outcomes in Industry-Sponsored Oncology Clinical Trials and Product Labels. Kathleen Gondek, Pierre-Philippe Sagnier, Kim Gilchrist, and J. Michael Woolley
• Patient-Reported Outcomes Supporting Anticancer Product Approvals. Edwin P. Rock, Dianne L. Kennedy, Melissa H. Furness, William F. Pierce, Richard Pazdur, and Laurie B. Burke
• Funding Patient-Reported Outcomes in Cancer Clinical Trials. Carol M. Moinpour, Andrea M. Denicoff, Deborah Watkins Bruner, Alice B. Kornblith, Stephanie R. Land, Ann O'Mara, and Edward Trimble
• Standardizing Patient-Reported Outcomes Assessment in Cancer Clinical Trials: A Patient-Reported Outcomes Measurement Information System Initiative. Sofia F. Garcia, David Cella, Steven B. Clauser, Kathryn E. Flynn, Jin-Shei Lai, Bryce B. Reeve, Ashley Wilder Smith, Arthur A. Stone, and Kevin Weinfurt
• Compliance With Patient-Reported Outcomes in Multicenter Clinical Trials: Methodologic and Practical Approaches. Stephanie R. Land, Marcie W. Ritter, Joseph P. Costantino, Thomas B. Julian, Walter M. Cronin, Sarah R. Haile, Norman Wolmark, and Patricia A. Ganz
• Patient-Reported Outcomes and the Evolution of Adverse Event Reporting in Oncology. Andy Trotti, A. Dimitrios Colevas, Ann Setser, and Ethan Basch
• Health-Related Quality of Life and Symptom Management Research Sponsored by the National Cancer Institute. Lori M. Minasian, Ann M. O'Mara, Bryce B. Reeve, Andrea M. Denicoff, Joseph Kelaghan, Julia H. Rowland, and Edward L. Trimble
• Patient-Reported Outcomes Assessment in Cancer Trials: Taking Stock, Moving Forward. Joseph Lipscomb, Bryce B. Reeve, Steven B. Clauser, Jeffrey S. Abrams, Deborah Watkins Bruner, Laurie B. Burke, Andrea M. Denicoff, Patricia A. Ganz, Kathleen Gondek, Lori M. Minasian, Ann M. O'Mara, Dennis A. Revicki, Edwin P. Rock, Julia H. Rowland, Maria Sgambati, and Edward L. Trimble