E-Newsletter - February 2017

understanding alliance membership accrual credits

Alliance Main Members are required to accrue 15 patient enrollments to treatment and cancer control intervention studies per year, based on a three-year rolling average. Affiliate members are required to accrue five patient enrollments annually, based on a three-year rolling average. The Affiliate/Sub-Affiliate or NCORP component/subcomponent accruals are counted toward the Main Member accrual requirement.

Membership Accrual Credits. The Alliance assigns 1.0 Alliance membership accrual credit for enrollments to treatment and intervention studies. The Alliance assigns partial (0.25) membership accrual credit for enrollment to Alliance (non-legacy) ancillary non-treatment studies and sub-studies.

Additionally, select treatment trials have been assigned double credit. The studies assigned 2.0 membership accrual credits include:

  • Alliance 30610 “Phase III comparison of thoracic radiotherapy regimens in patients with limited small cell lung cancer also receiving cisplatin and etoposide”
  • Alliance 40903 “Phase II study neoadjuvant letrozole for postmenopausal women with estrogen receptor positive ductal carcinoma in situ (DCIS)”
  • Alliance 51101 “A randomized phase II trial of myeloablative versus non-myeloablative consolidation chemotherapy for newly diagnosed primary CNS B-cell lymphoma”
  • Alliance A091302 “Randomized phase II study of sorafenib with or without everolimus in patients with radioactive iodine refractory Hürthle cell thyroid cancer”
  • Alliance A091305 "A phase 2 randomized study of efatutazone, an oral PPAR agonist, in combination with paclitaxel versus paclitaxel in patients with advanced anaplastic thyroid cancer"
  • N1048 “A phase II/III trial of neoadjuvant FOLFOX with selective use of combination XRT in locally advanced rectal cancer”
  • Z11102 “Impact of breast conservation surgery on surgical outcomes and cosmesis in patients with multiple ipsilateral breast cancers (MIBC)”

The following screening non-treatment studies have been approved for membership accrual credit:

  • GLNE 010 “Validation and comparison of biomarkers for the early detection of colorectal adenocarcinoma” [trial suspended] – 1.0 credit
  • Alliance A151216 “Adjuvant lung cancer enrichment marker identification and sequencing trial (ALCHEMIST)” – 1.0 credit
  • EAY131 “Molecular analysis for therapy choice (MATCH)" – 1.0 credit
  • SWOG S1400 “Phase II/III biomarker-driven master protocol for second line therapy of squamous cell lung cancer” (Lung-MAP) -- 1.0 credit

The pre-registration step of the following studies have been approved for membership accrual credit:

  • Alliance A011202 "A randomized phase III trial comparing axillary lymph node dissection to axillary radiation in breast cancer patients (cT1-3 N1) who have positive sentinel lymph node disease after neoadjuvant chemotherapy" – 0.20 credit
  • Alliance A021302 "Impact of early FDG-PET directed intervention of preoperative therapy for locally advanced gastric cancer: A random assignment phase II study” — 1.0 credit
  • Alliance A071101 "A phase II randomized trial comparing the efficacy of heat shock protein-peptide complex-96 (HSPPC-96) (NSC #725085, Alliance IND# 15380) vaccine given with bevacizumab versus bevacizumab alone in the treatment of surgically resective recurrent glioblastoma multiforme (GBM)” — 0.20 credit

The following observational study has been approved for 1.0 membership accrual credit at the time of enrollment with no further credits assigned if the patient enrolls on the cohort:

  • NHLBI-MDS "The National Myelodysplastic Syndromes (MDS) Study”  

Please note: The membership accrual credits count only toward Alliance membership requirements. The membership credits do not affect per case payments or DCP/NCORP credits. 

For more information about Alliance member accrual requirements, refer to the Alliance Bylaws and Policies and Procedures, Section 2. Alliance members can also contact Marcia Kelly, Alliance Membership Manager, by phone 773-834-7676 or by e-mail Membership@AllianceNCTN.org.


Alliance Foundation Trials (AFT) Membership Accrual Credits

Enrollment to Alliance Foundation Trials (AFT) will count toward Alliance membership accrual credit but only after the institutional members have met their minimum membership accrual requirement via federally funded trials. For more information, visit the AFT website.

 

For other articles in the February issue of the Alliance E-News newsletter, see below.