SGO Issues October 9, 2014
SGO guidance doc for ovarian cancer published
SGO Practice Survey helps with salary negotiation
NCI exceptional responders to cancer therapy study launched
2013 PQRS and eRx reports now available
SGO bylaws amendments passed
Winter Meeting registration and housing open
SGO’s “Guidance document for clinical trial designs in ovarian cancer: A changing paradigm” has been published in the October 2014 issue of Gynecologic Oncology. This is a follow-up document to “Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper” which was published in the January 2014 journal.
The most recent article addresses the fact that there has not been a new drug approved for ovarian cancer since 2006.
“We’ve had an ongoing dialogue with a number of stakeholders including the Cancer Therapy Evaluation Program, National Cancer Institute, and the Food and Drug Administration. This second article is a summary of that process,” said lead author Thomas Herzog, MD, the newly appointed Clinical Director of the University of Cincinnati Cancer Institute at the University of Cincinnati. “It’s a way of voicing the SGO’s perspective of where things are headed in terms of clinical trial endpoints selection in drug development.”
Dr. Herzog added that with the greater stratification and sub-classification of ovarian cancers, large-scale, all-inclusive phase III clinical trials with thousands of patients are becoming more difficult to perform once patient groups are categorized by different histologies, genetic mutations, and pathway aberrations.
“The paradigm is changing rapidly with regard to our tradition of large Phase III trials,” he said. “While Phase III trials remain the standard, they’re going to have to be conducted more nimbly and creatively, looking at factors such as stratification, adaptability to close arms lacking efficacy and consideration of surrogate endpoints.”
Since traditional Phase III trials for ovarian cancer have become too expensive, too lengthy and have often become irrelevant by the time the trial closes, the SGO is trying to organize a clinical trials workshop with regulatory authorities sometime next year.
“With our patients in mind, we have the perspective that perhaps further dialogue about clinical trial endpoints and other design features would potentially result in new guidelines that reflect the realities of recent basic science discoveries and thereby overcome barriers to new drug development for this disease,” said Dr. Herzog.
Co-authors on the paper are Ronald D. Alvarez, MD; Angeles Secord, MD; Barbara A. Goff, MD; Robert S. Mannel, MD; Bradley J. Monk, MD; and Robert L. Coleman, MD.
Full and candidate members now have until Oct. 13 to take SGO’s Practice Survey. Tri A. Dinh, MD, said that he has used the results of the 2010 State of the Subspecialty report to ensure that he was being paid what his work was worth after he compared himself with peers based on his level of productivity, years of experience and geographic location.
Dr. Dinh, now with the Mayo Clinic in Jacksonville, FL, described the SGO Practice Survey report as a valuable resource for gynecologic oncologists, especially for those who are coming out of fellowship. “There is no other data I know of for physician salary guidelines that is as accurate as the SGO Practice Survey,” he said.
“The SGO Practice Survey is very detailed; it has demographics on gender, years out of fellowship, and salary guidelines broken down by Relative Value Units (RVUs),” said Dr. Dinh, who noted that everything that gynecologic oncologists do—including office visits, surgery, and chemotherapy—is assigned an RVU.
Earlier in his career, Dr. Dinh was able to use data from the Practice Survey to negotiate a substantial salary increase at a previous institution. “Without the SGO Practice Survey I would not have known what my work was worth,” he said. “The data is only as good as the number of people who participate and how much they put into it.”
SGO Practice Survey co-chair James W. Orr, MD, FACOG, FACS, of Florida Gynecologic Oncology in Fort Myers, said that statistically significant regional, national and practice data provide members with a valid reference and supporting information to properly assist with contract negotiations. “This includes RVUs for the Medicare reimbursement formula, number of hours on call, education reimbursement and even recruiting,” he added.
Dr. Orr emphasized that since data for the SGO Practice Survey is gathered every five years, it is crucial to include the most current information on the subspecialty. “Our 2010 State of the Subspecialty report is fast becoming out of date, and the next opportunity to complete the survey is five years away,” he said. “I urge every qualified SGO member to make their voices heard within the subspecialty of gynecologic oncology and take the time to fill out the Practice Survey.”
Those who complete the survey will receive the 2015 State of the Subspecialty report at no charge.
On Sept. 24 the National Cancer Institute (NCI) announced the Exceptional Responders Initiative, a study to investigate the molecular underpinnings of exceptional responses to systemic treatment in cancer patients.
To support this initiative, NCI is asking clinicians to identify potential exceptional responder cases. An exceptional responder is a patient having either complete or partial response to experimental or standard cancer therapy lasting for six months or more. This could be from patients enrolled in early phase clinical trials where fewer than 10% responded or could be from patients treated on later phase trials of single agents or combinations. It can also be from patients having exceptional responses from established cancer treatment.
NCI plans to examine tissue and clinical data from up to 300 exceptional responder cases and will conduct genome sequencing analyses. The information will be stored in a controlled access database so that qualified investigators will be able to access it for further research.
Questions and answers about the Exceptional Responders Initiative are available at the Cancer.gov website. Questions from investigators, physicians, and hospitals looking to contribute tumor samples can be sent via email.
The 2013 Physician Quality Reporting System (PQRS) and 2013 Electronic Prescribing (eRx) Incentive Program feedback reports are now available for eligible professionals who submitted quality data on Medicare Physician Fee Schedule Part B services between Jan. 1, 2013, and Dec. 31, 2013. SGO members in private practice have until Dec. 31 to make changes for 2014 reporting.
Individual eligible professionals who submitted 2013 PQRS data, or individual eligible professionals and group practices who submitted 2013 eRx data, can retrieve their 2013 Feedback Reports through two methods:
- National Provider Identifier (NPI)-level reports can be requested through CMS’ Communication Support Page
- Taxpayer Identification Number (TIN) – level reports are available for download on the Physician and Other Health Care Professionals Quality Reporting Portal
The SGO bylaw amendment voting period is complete. Both proposed amendments were accepted by vote of the membership and the newly updated bylaws are available on sgo.org. SGO thanks all members who participated.
Registration and housing is now open for SGO’s 20th Anniversary Winter Meeting, Feb. 19-21, 2015, at the Snowbird Ski and Summer Resort near Salt Lake City, UT. Discounted room rates ($264/night) are guaranteed through Wednesday, Jan. 14, 2015, and are available on a first-come, first-served basis.