Cancer Clinical Trials

Transcription

1 Cancer Clinical Trials Robert M. Flanigan, MD, FACS Vice-Chair, Accreditation Committee Commission on Cancer, Chicago, IL Presenter Disclosure I have no financial interests or other relationship with manufacturers of commercial products, suppliers of commercial services, or commercial supporters. My presentation will not include any discussion of the unlabeled use of a product or a product under investigational use. 1

2 Program Planning Committee Disclosure The following members of the Program Planning Committee have nothing to disclose: Connie Bura M. Asa Carter Greer Gay Jerri Linn Phillips Andrew K. Stewart Impact of Clinical Trials Why are they important? Clinical trials support advances in medicine Why should patients participate? According to US National Institute of Health, clinical trial participants: Can play more active role in their own health care Gain access to new research treatments before they are widely available Help others by contributing to medical research Clinical Trial Accrual S1.9: As appropriate to the cancer program category, the required percentage of patients is accrued to cancer-related clinical trials each year. The clinical trial coordinator or representative reports clinical trial participation to the cancer committee each year. 2

3 Why is trial accrual important? Clinical research advances science Ensures patient care approaches the highest possible level of quality Programs participating in cancer-related clinical research demonstrate that: An independent peer review mechanism consistent with national standards is in place and used Research projects must be approved by an internal or external institutional review board (IRB) Patients participating in clinical trials must give their informed written consent, unless verbal consent has been specified by the IRB Patient Eligibility When does the patient count? Seen at your program for diagnosis and/or treatment and placed on a cancer-related clinical trial through your program Seen at your program for diagnosis and/or treatment and placed on a cancer-related clinical trial through the office of a staff physician Seen at your program for diagnosis and/or treatment and placed on a cancer-related clinical trial through another program (referral) Seen at your program for any reason and placed on a cancer prevention or cancer control clinical trial 3

4 Cooperation is key! All CoC-accredited programs, including the NCI-designated Comprehensive Cancer Center facilities, are expected to provide enrollment data and assistance to those cancer programs that refer patients for enrollment in a cancer-related clinical trial Treatment-related clinical trial source examples: Cooperative cancer clinical trial groups NCI-sponsored programs Pharmaceutical company research Locally developed, peer-reviewed research What are some examples of cancer prevention and cancer control research? Primary prevention of cancer Early detection of cancer Quality of life related to cancer (supportive care trials) Economics of care related to cancer 4

5 Keys to successful compliance A research coordinator, data manager, or other clinical research professional in place to: assist with enrolling patients monitoring patient accrual identify and provide information and education about new cancer related clinical trials Documentation for compliance Patient accrual must be monitored and reported to the cancer committee each year The report includes number of patients accrued to cancer-related clinical trials each year The report is documented in the cancer committee minutes When does my program have to meet this standard? Phase in Time Period Until 2015, cancer programs are expected to achieve the minimum accrual percentage based on the program category at the end of 2011, set forth in Standard 5.2 as published in Cancer Program Standards 2009, Revised Edition 5

6 Requirements (by %) Annual Analytic Cases Effective in 2015 NEW Category Minimum (each year) Commendation (each year) INCP 6% (no change) 8% (no change) NCIP 20% not applicable ACAD 6% 8% VACP 2% (no change) 4% (no change) COMP 4% 6% CCP 2% 4% HACP exempt 2% PCP 30% 40% FCP 2% 4% Measuring compliance/commendation As appropriate to the cancer program category, the minimum/commendation required percentage of patients is accrued to cancer-related clinical trials The annual patient accruals to cancer-related clinical trials are monitored The annual number of patient accruals to cancerrelated clinical trials is reported to the cancer committee The report is documented in the cancer committee minutes Questions? Please visit the CoC s CAnswer Forum to post questions on this Webinar: Additional resources on the new Standards can be found at the Accreditation Best Practice Repository: Webpage addresses and log in instructions can be found in the attachment posted along with the presentation handouts. 6