Clinical study reports (CSRs)
Statistics Collaborative, Inc. (SCI) has extensive experience both in preparing entire clinical study reports (CSRs) and in preparing statistical sections for them. The CSRs have addressed drugs, biologics, and devices. Our work has been consistently recognized among our clients and peers for its quality. We recognize that often "less is more" and that a well-crafted, succinct presentation of results can paint a clear picture of a product's safety and efficacy. We tailor each analysis to the problem at hand, rather than using a one-size-fits-all approach.
Our clients seek us out when their trials present novel analytical issues that require careful thought and rigorous attention to detail.
Some recent examples include:
- Phase 3 trial in an orphan indication: SCI anticipated the possibility of baseline imbalances in the trial's efficacy outcome measure by pre-specifying the baseline value as a covariate in the primary analysis. When a large imbalance was identified after the trial was unmasked, we performed a battery of sensitivity analyses to address the robustness of the trial's results. Following the successful approval of the product, the company rehired SCI to prepare CSRs for four other Phase 3 trials in another orphan indication.
- Two Phase 3 cardiovascular trials with multiple primary outcomes: A six minute walk test was one of the primary outcomes. SCI identified that investigators were inconsistently recording walk distances on the case report forms for subjects who were unable to perform the test. Because we identified the problem before the trials were unmasked, the client was able to correct the database before the final data cut for the CSR, thereby preserving the interpretability of the outcome.
- Device for treatment of aneurysms: SCI addressed the lack of a contemporaneous control group using propensity scores to adjust for group differences with historical controls. After preparing the CSRs, we assisted in drafting the briefing book, participated in mock panels, and performed ad hoc analyses in preparation for the company's successful meeting with the Food and Drug Administration (FDA) Advisory Committee.