Statistics Collaborative, Inc. (SCI) works on many clinical trials studying various types of cancers, solid tumors, carcinoma, sarcoma, leukemia, lymphoma, and myeloma. Our experience with solid tumors includes assisting in trials of colon, lung, breast, and head and neck cancers. The investigational therapies aim to treat the underlying primary cancers, as well as metastatic disease. Some trials study treatments for sequelae of the primary therapies, such as oral mucositis and anemia. The therapies include chemotherapies, radiation therapies, biological therapies, and vaccines.
SCI’s role in this arena has been primarily to support Data Monitoring Committees (DMCs) that monitor the safety of subjects in Phase 2 and 3 cancer trials. We also prepare interim analyses of efficacy.
In addition to supporting DMCs, SCI assists clients both in designing cancer trials and in preparing statistical analysis plans. We frequently review and edit protocols or write their statistical sections. SCI provides input in defining or choosing the primary outcomes and proposes methods of analysis. We also conduct analyses on final, locked databases for inclusion in reports to regulatory agencies and for use in the design of confirmatory trials.
Examples of SCI’s work in oncology:
- Multiple myeloma: SCI performed interim safety and efficacy analyses of a large trial in second-line and refractory multiple myeloma. The trial’s DMC recommended that the study discontinue early because of evidence of overwhelming benefit. The DMC made its decision after reviewing a battery of unplanned sensitivity and subgroup analyses that SCI performed, which confirmed the benefit seen in the primary analysis.
- Oral mucositis and anemia: We have provided interim safety and futility analyses for DMC review for a series of trials seeking to reduce the incidence of oral mucositis. SCI has served as the independent statistical group reporting to the DMC for several trials studying anemia in cancer patients. We performed the final efficacy analysis for a trial evaluating the treatment of anemia in pediatric cancer patients.
- Brain cancer: SCI wrote an expert report on a novel brain tumor agent used to supplement the sponsor’s European filing. The report focused on robustness with respect to choice of analysis, stratification, and subgroup selection. SCI assisted in the design of randomized, open-label Phase 3 studies in oncology patients with brain metastases and later prepared interim DMC reports. The main challenges were related to choosing and then auditing the adaptive randomization that was used to reduce bias in the open-label setting. A blinded events review committee adjudicated the primary efficacy outcome. SCI provided the sponsor with enough data so that the sponsor could prepare the blinded presentations without unblinding itself to the interim efficacy results.