The Prostate Cancer Roundtable has just announced an update to its national policy agenda — to include a focus on the importance of patient-reported outcomes data affecting quality of life in trials designed with survival as the primary endpoint.
The full text of the media release announcing this modification to the Roundtable’s policy agenda is given below.
Washington, DC, December 12, 2013 – The Prostate Cancer Roundtable has updated its shared national policy agenda for 2014 to include a new policy priority, based on the idea that Phase III clinical trials of new drugs and other forms of treatment that are being tested for their ability to extend overall or progression-free survival should, at the same time, be evaluated for their impact on at least one patient-reported outcome that affects quality of life — at least as a secondary endpoint. For example, does treatment with this drug delay onset of bone pain in men with disseminated prostate cancer?
On Monday, December 9, those attending the Prostate Cancer Roundtable meeting voted unanimously to approve the suggested language and add a new section to the Policy Agenda to read:
“We seek and encourage the inclusion of quality-of-life-related endpoints, based on patient-reported outcomes data, in pivotal trials of all biologic and pharmaceutical agents being assessed for regulatory approval in the treatment of prostate cancer with a primary endpoint of improved survival — such that quality-of-life-related data (positive or negative) as well as survival data can be included in labeling for products indicated for treatment of prostate cancer as and when appropriate.”
This revised policy agenda can be found at www.prostatecancerroundtable.net/agenda and serves as the group’s policy priorities in discussions with legislators, media and advocates over the next year. The twelve organizations of the Prostate Cancer Roundtable represent the national organizations leading the fight against prostate cancer and speaking on behalf of the hundreds of thousands of patients diagnosed with prostate cancer each year and the estimated 2.2 million men living today who have been diagnosed with the disease and their families.
“While we appreciate the heroic and essential efforts of drug developers, the FDA, and the clinical research community to improve overall patient survival, we also believe that it is critical to patients and families that we study whether life-extending new treatments also have impact on quality of life,” said Thomas Kirk, CEO, Us TOO International.
“We’re hoping that our inclusion of quality-of-life endpoints as part of our policy agenda will resonate with those stakeholders directly involved with providing prostate cancer care,” said Tom Farrington, Founder and President, Prostate Health Education Network. “This is an ambitious but worthy goal which will result in better care for those who not only want their lives extended but also desire a life as close as possible as before the disease.”
“Life extension is valuable for patients and the prostate cancer community as a whole,” said Wendy Poage, President, Prostate Conditions Education Council. “But being able to also enjoy life, without extensive side effects from treatments and without painful symptoms from their cancer is in many cases, just as important for cancer patients. By including quality of life measures in clinical trials, we will not only better understand the impact of new treatments on patients, but this new policy agenda may also help draw attention to patient centered concerns and provide better cancer care.”
About the Prostate Cancer Roundtable:
The Prostate Cancer Roundtable, representing America’s prostate cancer community, is a group of independent, patient-centric, not-for-profit organizations that cooperate to foster the development of policies supporting high quality prostate cancer research, the prevention and early detection of clinically significant prostate cancer, the appropriate care and effective treatment of men with prostate cancer, and the appropriate education of all men at risk for this disease.
The members of the Prostate Cancer Roundtable are:
• Ed Randall’s Fans for the Cure (www.fans4thecure.org)
• Malecare Prostate Cancer Support (www.malecare.org)
• Men’s Health Network (www.menshealthnetwork.org)
• National Alliance of State Prostate Cancer Coalitions (www.naspcc.org)
• Prostate Cancer International (www.pcainternational.org)
• Prostate Conditions Education Council (www.prostateconditions.org)
• Prostate Health Education Network (www.prostatehealthed.org)
• The Prostate Net (www.prostatenet.org)
• Us TOO International Prostate Cancer Education and Support Network (www.ustoo.org)
• Women Against Prostate Cancer (www.womenagainstprostatecancer.org)
• ZERO – The End of Prostate Cancer (www.zerocancer.org)
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment, Uncategorized | Tagged: agenda, endpoint, outcome, patient-reported, policy, quality of life, Roundtable, trial |