Drug Development Consulting

RxMD provides strategy and execution that expedite clinical research programs. We have navigated our clients through a variety of drug development issues.

 

Scientific Monitoring

RxMD requested to oversee leading CRO faltering in large Phase II trial. RxMD makes decisions on eligibility, protocol violators and deviators based on non-inferiority nature of trial (primary efficacy analysis population = evaluable population) for successful conduct of trial, data review, database closure, interpretation of results and finalization of study report. RxMD provides insight on nuances of study design, phase of clinical trial, and impact on statistical analysis.

 

Study Management

Sponsor delegates to RxMD conduct and oversight of large phase II non-inferiority clinical trial being conducted by premier CRO. RxMD successfully executes trial design, case report forms, database validations, scientific review of data, blinded signal detection, development of statistical analysis plan, identification of programming errors in blinded statistical outputs, interpretation of unblinded outputs and authoring of final study report.

 

Statistical Analysis Plan (SAP) Development

RxMD on review of biopharma SAP for Phase III superiority trial notes that analysis for primary efficacy (ITT) population does not account for visit windows, values outside windows, missing values, multiple values within windows, programming for major violations (exclusions from per protocol population), and inconsistencies between SAP and CRF design. RxMD recommends and implements changes on behalf of biopharma and FDA concurs with SAP revisions.

 

Novel Study Designs

Sponsor consents to a post approval commitment to establish efficacy in an immunocompromised population (precludes placebo control). RxMD establishes definition for immunocompromised population and designs trial using two active control arms to be compared with a placebo arm from the pivotal trial in healthy adults. Novel strategy meets with regulatory approval.

 

Signal Detection

Sponsor conducting large Phase II global clinical trial. RxMD requested to review data in a blinded manner on an ongoing basis to detect signals. RxMD recognizes overall AE rate for cutaneous reaction in all treatment arms is greater than background rate in population with the disease. On unblinding, findings are confirmed, and development of the drug is halted

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