Statistical Center Update. Phyllis Goodman, M.S. Coordinating Statistician

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2 Statistical Center Update Phyllis Goodman, M.S. Coordinating Statistician 2

3 Specimen labels Updated to reflect 3 types of specimen needs Large labels pathology specimens Small labels blood products, urine Small labels (pharmacokinetics) addition of details of collection time (hour:minute) Posted on CRA Workbench Tools of the trade Link from specimens page 3

4 Specimen label examples Large labels Small labels Small labels Pharmacokinetics 4

5 S FDA A Randomized Phase III Trial of Lenalidomide and Low Dose Dexamethasone (LLD) Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant Results presented at the 57th annual meeting ASH, possibly indicating a new standard of care for myeloma Median progression-free survival on the three-drug arm that included Bortezomib was 43 months (vs. 30) and survival a median of 75 months (vs. 64) Celgene Corporation has contracted with SWOG to expand data collection and site monitoring and perform 100% source documentation (PAREXEL) verification 5

6 S FDA Additional data (baseline, second primary, BMT) will be collected on all patients Protocol revision #24 4 new (or revised) ecrfs Extending the follow-up period for patients still alive with additional data collection Patients must be re-consented Contact patients whose follow-up has already ended Generous per-patient compensation is available S0777CelgeneDM@crab.org 6

7 S FDA Revision #24 has been approved by CTEP and will undergo review by CIRB on October 6 Local IRBs still need to review this as well since this was never under the purview of the CIRB initially SWOG will be releasing the new CRFs by the end of this week Expectations will be set for these new forms after the revision has been distributed Information cards with relevant information about S0777 are at the registration desk and available after this meeting 7

8 S FDA S0106 A Phase III Study of the Addition of Mylotarg Induction Therapy Versus Standard Induction With Daunomycin and Ara-C Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Mylotarg or No Additional Therapy for Patients Under Age 61 With Previously Untreated De Novo Acute AML Data were used in a patient-level meta-analysis which will be submitted as part of FDA submissions by Pfizer SWOG data were used for secondary analyses 8

9 S FDA FDA will begin site-level inspections in order to ensure the quality of the data used in the analysis Pfizer has requested that information be distributed to sites regarding the expectations of a site inspection Two documents will be available on the protocol abstract page Identify a key point person to oversee preparation for inspection and to be available to answer any questions that might arise during inspection Based on past experience, inspections are expected to begin as soon as December 2016 Training WebEx is being planned 9

10 Other updates CRA Workbench Reports Fine tuning, downloadable to Excel Increased use of NCI Code as opposed to SWOG site ID Long-term goal is to combine information across registrations by sites as SWOG and non-swog 10

11 Evonne Lackey 11

12 Changes over the last 60 years. 12

13 Patient charts

14 Data capture 14

15 ata capture 15

16 atient registration process 16

17 Specimens Pathology Chair, maintained slides centrally for path review Large number of studies had path review for eligibility Repository moved to Statistical Center + some individual disease-specific repositories Increased number of specimen types Introduction of Specimen Tracking (2006) Central repository Multiple moves, now Nationwide in Columbus 17

18 eport of Studies 18

19 Why we do what we do 19

20 For the patients Over 200,000 patients have participated in SWOG trials Understanding cancer and the disease process to provide better treatments and prevention strategies leading to improved survival 20

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