Why are we runnin’? A (possibly) better approach to more accruals

1. Mindy Whisnant, BA, CRA, CCRP Decatur Memorial Hospital Central IL CCOP Why are we runnin’?A (possibly) better approach to more accruals

2. “Where are we runnin’” By Lenny Kravtiz (lyrics) Fast lane, High speed, On the grind, 24/7, No timeAlways runnin' here and there, Chasin' the moneySo much jibber jabbers, Cloggin' up our soul Where are we runnin'We need some time to clear our headsWhere are we runnin‘, Keep on working 'til we're deadWhere are we runnin‘, Oo wee oo wee ooWhere are we runnin' now So WHY are we runnin’ as cancer control CRAs?

3. To get what credits are available…. • Many available CC/SM studies are “different” than 5 years ago, making the available credits seem harder to get… • Blood components are requiring special training and equipment, more time consuming • Screening processes for the patient population can be more difficult, sometimes looking at a past population vs a current population • Limited number of slots for participating CCOPS or sites

4. While the credits are available… Many studies have been in development for years and are highly anticipated…Once they become activated, the available slots fill very quickly If your site has not been accruing well, you may lose the opportunity to have access to special training or equipment before it is even available… And even if your site was a site that was allowed on study, if you are not accruing fast enough to show progress, you may need to return equipment for “lack of accrual” 

5. Are there other issues to minority accrual? • Our minority population is smaller, only being 22% of our community’s population • Based on Tumor Registry’s numbers: pulling from 2010 cases, there were 1024 cases, only 68 (7%) were African American, there were 3 cases, only 3‑ that had an Asian, Native American, and one Hispanic. • We seem to receive African American cases in a much later stage, which may decrease their access to studies, based on disease advancement. • Education level and education of research in general is sometimes a barrier as well.

6. A new approach to reviewing protocols to gain access to the most available population…. • Physician/Team approach • Completed on every new CC/SM study BEFORE IRB review • Team consists of Lead CRA for the study, Regulatory Specialists input, Tumor Registry data, Billing office or Schedulers

7. What does the team do? • Lead CRA for the study: full review of the protocol, with special attention to blood draws, special training, timing of screening, etc • Regulatory Specialists: when can this protocol go to IRB? Do we need any special “extras” like a Fast Fact Sheet, and advertising, etc • Tumor Registry data: How many patients have we seen of this disease type in the last few months/years? • Billing office or Schedulers: How many are we currently seeing?

8. EXAMPLE of Team Review • The following slides are an example of a team review completed on the newly activated study: CCCWFU 97609 for new breast cancer patients receiving RT, relevant to this panel due to its minority population limitations…There are only so many cases for Caucasian and African American patients that are needed, we needed to be prepared for how many we could TRULY accrue….

9. CCCWFU 97609: Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity

10. Brief Eligibility • • Female subjects newly diagnosed with breast carcinoma, stage 0–IIIA, post-lumpectomy, quadrantectomy, or mastectomy • • Plan to receive adjuvant radiation to the breast or chest wall +/- regional lymph nodes. The following parameters must be met: total dose >40Gy, dose per fraction >1.8 – 2.0Gy including hypofractionated regimens, use of 2D, 3D conformal, or IMRT treatment techniques (skin sparing IMRT patients excluded ). • Verified with Rad Onc, all doses are within their normal prescription • • Adjuvant hormonal therapy will be allowed prior to, during and/or after RT at the discretion of a medical oncologist. • • Targeted therapies such as Herceptin will be allowed prior to, during, and/or after RT at the discretion of the medical oncologist.

11. Schema candidate identified for post-lumpectomy, - quadrantectomy, or –mastectomy RT consent and registration Baseline labs, questionnaires, photographs Week 3 Photographs for patients receiving standard fractionation only *which is all our pts* Last Day RT; 1 month post RT; 2 months post RT; 6 months post RT; 12 months post RT complete labs, Questionnaires and photographs as indicated in Section 7.9 Study Parameters Table

12. Study population • Study Sample: 1000 (400 White, 200 African American, 200 Hispanic/Latino, 100 Asian/Native Hawaiian or Pacific Islander, 100 American Indian/Alaskan Native) • Study Duration: 52 weeks • This study has been live and active to the CCOPs since 09/29/2011.

13. Laboratory study plan From each patient, we will collect questionnaires, blood and urine samples before and after RT for genotyping, DNA damage and cell cycle assays, total antioxidant levels, urine cotinine to estimate cigarette smoke exposure, and quality of life. Whole blood (≈25-30 ml) will be collected at baseline and end of RT). **No more blood than U10054**

14. Clinical study plan Once the radiation oncologist has determined the patient is a candidate for post-lumpectomy, - quadrantectomy, or –mastectomy RT, and the patient has given consent to proceed with the recommended RT, they will be approached for this study. Once the patient has consented to participate in the study, their baseline pre-RT assessments can be completed during the radiation treatment-planning process.

15. Study plan continued… No concurrent chemo Concurrent hormonal treatment is fine Follow up assessments at Week 3, End of RT, 1 month, 2 months, 6 months and 1 year NO PILLS TO TAKE! (but the study is not offering to help protect skin or reduce skin toxicities, just study them)

16. How many patients do we have access to? • CCCWFU CCOP Research Base Accrual CCOP wide • 380 Caucasian, not of Hispanic origin • 177 Black, not of Hispanic origin

17. How many RT Breast consults do we see? • Some consults don’t lead to RT • Sometime can be months before RT starts (surgery, chemo, etc) • Approx 15-20 new consults per month • June had 19 • July had 14 • U10054 has been “functioning” for 4 months • We are averaging about 5 a month, out of those possible 15 a month….

18. Compared to U10054 ladies… • Out of our local 19 patients currently enrolled (at the time of this slide) • 17 are Caucasian • 2 are African American • We are running a higher percentage than normal, 10% than our cases available

19. Supplies …. Lab kits will be supplied Camera: Can’t find where it will be supplied or that they have a special camera that needs to be used…But one that has white calibration ability would be GREAT 

20. Mindy’s request and suggestion Get this to the IRB as soon as possible, would like a slot on the December IRB Workload: this will get us past the closure of U10054 and the completion of its patients This study will hit hard and fast and then close in no time, the relationship with RT and patient flow is already established, Let’s run with it. WE HAVE RAD ONC’S BLESSING 

21. So why are we runnin’? • We are running because we are trying to gain as many appropriate accruals as possible in being prepared in the best possible way BEFORE the study hits IRB. • Preparation keeps a CRA happy, and happy CRAs lead to better accruals 

22. Who else is happy? • This is a “many”fold process: • Physicians are happy because they know what is coming • CRAs are happy because they are excited and prepared • Regulatory is happy because everything that could possibly be needed is available and ready to go with the Initial Review

23. THANK YOU!