SGO Issues April 17, 2014

sgo-issues

SGO Issues April 17, 2014

FDA issues statement on morcellation
Open Forum examines alternative payment models
NCI clarifies forthcoming changes in clinical trials programs
OCRP announces funding opportunities for FY2014
Doctors needed for cervical cancer screening/treatment in Cambodia
SGO Obesity Toolkit can empower patients | Lauren S. Prescott, MD

FDA issues statement on morcellation

The Food and Drug Administration today issued a statement discouraging the use of laparoscopic power morcellation for removal of uterus or uterine fibroids. As an SGO member, you may be contacted by the media or others. For your reference, SGO’s statement on morcellation, announced in December 2013, is here. SGO further clarified its statement in a letter to the editor in the April 2014 issue of Lancet Oncology.Other important SGO practice statements and guidelines can be found here.

Open Forum examines alternative payment models

Harold D. Miller

Harold D. Miller

Slide decks are available from the Annual Meeting’s Open Forum with Harold D. Miller, President and CEO of the Center for Healthcare Quality and Payment Reform, and the summary of SGO’s Practice Summit by past president Ronald D. Alvarez, MD, which focused on payment reform and alternative payment models for physicians, hospitals and payers.

Building upon the momentum from the Annual Meeting, SGO provided the Center for Medicare and Medicaid Innovation (CMMI) a response to its Request for Information on Specialty Practitioner Payment Model Opportunities using the work to date on the endometrial cancer alternative payment model as an example of the type of procedural episode-based payment opportunities that could exist in gynecologic cancer care.

Additionally, the SGO practice summit workgroup is starting the process of preparing a case statement and seeking claims-based data as the next steps in the development of its endometrial cancer payment model.

SGO hopes to be in a position to start conversations with the payer community in late summer or early fall. Members interested in learning more about SGO’s efforts in this area or in becoming involved may contact Jessica Oldham, SGO Manager of Clinical Practice.

NCI clarifies forthcoming changes in clinical trials programs

On April 10, National Cancer Institute (NCI) director Harold Varmus issued an “open letter to the cancer community” to assure researchers that there would be no gap in funding for community oncology clinics.

The statement was released nearly a week after the NCI publically outlined its plans to consolidate several existing community-based clinical trials programs into an NCI Community Oncology Research Program (NCORP).

According to the NCI, NCORP will be comprised of some of the sites formerly funded through the Community Clinical Oncology Program (CCOPs), the Minority-based Community Clinical Oncology Program (MCCOPs), and the NCI Community Cancer Centers Program (NCCCP), as well as new grantee institutions.

The April 10 letter stated: “Current NCI grantees conducting community-based clinical research have voiced concerns about the maintenance of funding between the end of the current round of annual CCOP awards (June 1, 2014) and the start of the NCORP (now estimated to be Aug. 1, 2014). With Fiscal Year 2014 budgets now in place, our grantees can be assured that NCI will fund all CCOPs at their current levels during this period.

Citing unclear communication as the reason for the confusion, Varmus added that “currently funded investigators should continue the active, uninterrupted accrual of patients to new or ongoing clinical trials during this interval. As in the past, full funding for all research activities required to carry out approved studies will be provided.”

The announcements came as both ASCO and SGO expressed concern that the NCI would not maintain funding to the Community Clinical Oncology Program (CCOP), which makes clinical trials available to traditionally underserved populations.

In its earlier statement, the NCI announced the formation of a new National Clinical Trials Network (NCTN), adding that formal awards for the NCTN are expected to be made in the coming weeks. This year’s (FY2014) funding levels remain unchanged from FY2013.

According to the NCI: “The capacity of the NCTN to conduct clinical trials will reflect the difficulties of supporting a large program that is constrained by higher mandatory costs and by the rate of biomedical inflation, despite approximately constant dollars. The number of trials that can be funded and the network’s total enrollment (estimated to be about 17,000 patients in interventional trials and about 2,500 patients in trials that use molecular markers to screen for tumors) will be lower than in the past.”

Mary Jackson Scroggins, chair of the NRG Oncology (formerly GOG) Patient Advocate Committee, said that earlier reports of possible funding disruptions and the recent restructuring of clinical trials programs have the attention of patient advocates across the country.

“We certainly will be watching and monitoring the situation and doing what is necessary to make sure that women and all patients have access to meaningful clinical trials and to ongoing care,” said Scroggins. “I would love to have SGO members reach out to patient advocates and advocacy organizations so that we can work together to ensure the soundness of and accessibility to the clinical trials system. We should be partners in this ongoing process.”

Scroggins added that transparency in this process is critical to clinical trial participants and their families. “When patients consent to participate in clinical trials, they do so believing that there won’t be a breach of the contract,” she said. “Recent activities have heightened patient awareness of this possibility. Patient trust in the system—and the belief that patients are at the center of all activities—is essential to informed consent, the contract to participate in a clinical trial.”

Additional ongoing coverage of this issue is available at The Cancer Letter online.

OCRP announces funding opportunities for FY2014

On April 15 the Department of Defense Ovarian Cancer Research Program (OCRP) announced its funding opportunities for Fiscal Year 2014 (FY14) on Grants.gov.

The OCRP is administered by the U.S. Army Medical Research and Materiel Command (USAMRMC) through the Office of Congressionally Directed Medical Research Programs (CDMRP). Researchers can get additional information and apply for the following OCRP grant opportunities through the federal government’s single-entry portal, Grants.gov:

Clinical Translational Leverage Award: Pre-announcement is due June 3, 2014. Full application (if invited) is due Aug. 27, 2014.

Must be an independent investigator at or above the level of Assistant Professor (or equivalent)

  • Supports leveraging of human-based ovarian cancer resources in translational research to address high-impact research or unmet needs in ovarian cancer
  • Early-stage clinical trials are allowed; cost sharing is required for applications including a clinical trial
  • Pre-application is required; application is by invitation only
  • Maximum funding of $250,000 in direct costs (plus indirect costs)
  • Period of performance should not exceed 2 years

Investigator-Initiated Research Award: Pre-announcement is due June 3, 2014. Full application (if invited) is due Aug. 27, 2014.

Must be an independent investigator at or above the level of Assistant Professor (or equivalent)

  • Supports meritorious basic and clinically oriented research in ovarian cancer
  • Impact is an important review criterion
  • Preliminary data are required
  • Clinical trials are not allowed
  • Pre-application is required; application is by invitation only
  • Maximum funding of $450,000 in direct costs (plus indirect costs)
  • Period of performance should not exceed 3 years

Ovarian Cancer Academy Award: Early-Career Investigator pre-announcement is due June 3, 2014. Full application (if invited) is due Aug. 27, 2014.

Early-Career Investigator must be within the first 3 years of his/her first faculty position (or equivalent) at the time of submission. The first faculty position (or equivalent) may be either tenure-track or non-tenure track. Designated Mentor must be an independent ovarian cancer researcher and at the same institution as the Early-Career Investigator.

  • Supports the addition of new Early-Career Investigators to the unique, interactive virtual academy that will provide intensive mentoring, national networking, and a peer group for junior faculty
  • Designated mentor who is an experienced ovarian cancer researcher with ovarian cancer funding is required for Early-Career Investigators
  • Preliminary data are required
  • Institutional match of $50,000 per year is required
  • Pre-application is required; application is by invitation only
  • Maximum funding of $725,000 in direct costs (plus indirect costs)
  • Period of performance of 5 years

Ovarian Cancer Academy Leadership Award: Pre-announcement is due June 3, 2014. Full application (if invited) is due Aug. 20, 2014.

Dean must be an established ovarian cancer researcher. Embedded Assistant Dean must be an independent ovarian cancer research at a different institution from the Dean.

  • Supports visionary individuals who are established ovarian cancer researchers with a strong record of mentoring and commitment to leadership
  • Academy Dean, with Assistant Dean, will oversee the OCRP’s interactive academy of 10-12 Early-Career Investigators and their designated mentors, facilitate regular interactive communication among all Academy members, and assess research progress and career progression of the Early-Career Investigators
  • Maximum funding of about $1,000,000 in direct costs (plus indirect costs)
  • The Dean and Assistant Dean are expected to be partners in leading the Academy, and the direct cost funding should be divided accordingly
  • Period of performance is 5 years

Pilot Award: Pre-announcement is due May 22, 2014. Full application (if invited) is due Aug. 20, 2014.

Investigators at or above the postdoctoral level (or equivalent)

  • Supports conceptually innovative, high-risk/high-reward research that could ultimately lead to critical discoveries or major advancements that will drive the field of ovarian cancer research forward
  • Innovation and Impact are important review criteria
  • Preliminary data are not required, but allowed
  • Clinical trials are not allowed
  • Pre-application is required; application submission is by invitation only
  • Maximum funding of $225,000 in direct costs with additional $75,000 for optional nested Teal Postdoctoral Scholar (plus indirect costs)
  • Period of performance should not exceed 2 years

Doctors needed for cervical cancer screening/treatment in Cambodia

SGO’s partner organization Health Volunteers Overseas (HVO) is seeking volunteers to help develop a pilot program for the diagnosis and treatment of cervical cancer in Cambodia. Volunteers should be available for a two- to four-week period April through June 2014.

Sihanouk Hospital in Phnom Penh, Cambodia, is planning a pilot cervical cancer screening program for 1,000 women in 2014. The program would offer free Visual Inspection with Acetic Acid (VIA) screening, education and same-visit cryotherapy for neoplasia. LEEP and surgical therapy would also be available for more advanced disease. The target population will include women already in the hospital care system, including many who are HIV positive.

Sihanouk is coordinating the project with three other cervical cancer screening projects being planned in order to standardize care protocols and data collection. Volunteers would be responsible for training providers in cryotherapy and LEEP procedures, assisting and training surgeons with gynecological surgeries such as hysterectomies, and overseeing the development and quality of the pilot program at Sihanouk.

The HVO volunteers would also most likely be able to work with training providers at the other organizations that are moving ahead with screening programs: Marie Stopes International, Population Services International/Khmer (PSK) and the Reproductive Health Association of Cambodia. There will also be opportunities to work at the Women’s Clinic that Sihanouk runs and offer didactic teaching to general doctors-in-training at the hospital.

For more information, contact Peter Curran, MD at pgc@curransv.com.

SGO Obesity Toolkit can empower patients | Lauren S. Prescott, MD

Lauren Prescott, MD

Lauren Prescott, MD

In 1997, the World Health Organization formally recognized obesity as a global epidemic. Seventeen years later, we are still facing alarming increases in obesity. As a resident in obstetrics and gynecology and now a fellow in gynecologic oncology, I have struggled to adequately address obesity and weight management with many of my patients. Enabling patients to make meaningful changes to their lifestyle is an issue that most providers face on a daily basis. For these reasons I was thrilled when the SGO chose to address obesity as part a multi-year prevention campaign.

The annual meeting in Tampa, Florida marked the launch of the Communications Committee’s first initiative, the Obesity Toolkit. The toolkit is a fabulous reference for patients, gynecologic oncologists, primary care providers and affiliates. It consists of a comprehensive patient handout, a communication guide for the gynecologic oncologist to facilitate discussion about weight management and an overview of obesity-related issues with a focus on cancer directed at primary care providers. The SGO obesity webpage also includes links to clinical trials of exercise, diet and nutrition for cancer patients as well as a BMI calculator.

Thanks to the SGO, we have easily accessible tools to help empower our patients to take action to prevent cancer or use their cancer diagnosis as a gateway to a healthier lifestyle. As a provider I can now give my patients a handout about losing weight and direct them to the SGO website to find out more information about clinical trials and weight loss management. This is a huge step forward in improving cancer and survivorship care for our patients.

Read more SGO blogs at Voices.