Presentation on theme: "Why are we runnin’? A (possibly) better approach to more accruals"— Presentation transcript:
1Why are we runnin’? A (possibly) better approach to more accruals Mindy Whisnant, BA, CRA, CCRPDecatur Memorial HospitalCentral IL CCOP
2“Where are we runnin’” By Lenny Kravtiz (lyrics) Fast lane, High speed, On the grind, 24/7, No time Always runnin' here and there, Chasin' the money So much jibber jabbers, Cloggin' up our soulWhere are we runnin' We need some time to clear our heads Where are we runnin‘,Keep on working 'til we're dead Where are we runnin‘, Oo wee oo wee oo Where are we runnin' nowSo WHY are we runnin’ as cancer control CRAs?
3To 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 consumingScreening processes for the patient population can be more difficult, sometimes looking at a past population vs a current populationLimited number of slots for participating CCOPS or sites
4While 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 quicklyIf 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”
5Are there other issues to minority accrual? Our minority population is smaller, only being 22% of our community’s populationBased 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.
6A new approach to reviewing protocols to gain access to the most available population…. Physician/Team approachCompleted on every new CC/SM study BEFORE IRB reviewTeam consists of Lead CRA for the study, Regulatory Specialists input, Tumor Registry data, Billing office or Schedulers
7What 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, etcRegulatory Specialists: when can this protocol go to IRB? Do we need any special “extras” like a Fast Fact Sheet, and advertising, etcTumor 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?
8EXAMPLE of Team ReviewThe following slides are an example of a team review completed on the newly activated study: CCCWFU 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….
9CCCWFU 97609:Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity
10Brief 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.
11Schemacandidate identified for post-lumpectomy, - quadrantectomy, or –mastectomy RTconsent and registrationBaseline labs, questionnaires, photographsWeek 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 RTcomplete labs, Questionnaires and photographs as indicated in Section 7.9 Study Parameters Table
12Study population Study Duration: 52 weeks 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 weeksThis study has been live and active to the CCOPs since 09/29/2011.
13Laboratory study planFrom 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**
14Clinical study planOnce 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.
15Study plan continued… No concurrent chemo Concurrent hormonal treatment is fineFollow up assessments at Week 3, End of RT, 1 month, 2 months, 6 months and 1 yearNO PILLS TO TAKE!(but the study is not offering to help protect skin or reduce skin toxicities, just study them)
16How many patients do we have access to? CCCWFU CCOP Research Base Accrual CCOP wide380 Caucasian, not of Hispanic origin177 Black, not of Hispanic origin
17How many RT Breast consults do we see? Some consults don’t lead to RTSometime can be months before RT starts (surgery, chemo, etc)Approx new consults per monthJune had 19July had 14U10054 has been “functioning” for 4 monthsWe are averaging about 5 a month, out of those possible 15 a month….
18Compared to U10054 ladies…Out of our local 19 patients currently enrolled (at the time of this slide)17 are Caucasian2 are African AmericanWe are running a higher percentage than normal, 10% than our cases available
19Supplies …. 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
20Mindy’s request and suggestion Get this to the IRB as soon as possible, would like a slot on the December IRBWorkload: this will get us past the closure of U10054 and the completion of its patientsThis 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
21So 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
22Who else is happy? This is a “many”fold process: Physicians are happy because they know what is comingCRAs are happy because they are excited and preparedRegulatory is happy because everything that could possibly be needed is available and ready to go with the Initial Review