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Potential Pitfalls for Clinical Trials with an Overall Survival Endpoint

Overall survival (OS) is an endpoint of significant importance when assessing safety and efficacy in oncology studies. Multiple trial design decisions are made when planning the analysis of OS and analysis of OS is even more complicated when it is analyzed as a non-primary endpoint. Here are some common trial design elements to consider that may have potential pitfalls for your next study.

Blog Post

How to Place Overall Survival Results into a Proper Benefit-Risk Framework

Overall survival (OS) is both an important efficacy & safety endpoint for oncology trials. Often when study results are submitted for regulatory consideration, OS results are often “immature”/still in their early stages which makes them difficult to evaluate. Understanding how to place these results into a proper benefit-risk framework for consideration is therefore important when assessing a potential treatment’s viability.

Blog Post

4 Benefits of Combining Biometrics Services

Biometrics services (data management, biostatistics, data standards, and statistical programming) can be outsourced together as a unit or individually with different CRO partners. While splitting services up is perfectly acceptable, there are potential benefits that could be realized by having one contract research organization (CRO) support both the data management and biostatistical/programming components for your clinical trial project or program.

michael pace
Blog Post

Ensuring Successful Enrollment in Oncology Dose Escalation Trials

Oncology dose-escalation trials are a distinct entity, with nuances and considerations which set them apart from other therapeutic areas. From varying trial designs to the patients who participate, dose-finding clinical trials in oncology are a clinical research paradigm. Understanding strategies to facilitate success is key to study planning and execution, from feasibility to site selection through enrollment and treatment.

Blog Post

How Do You Determine the Best Clinical Pharmacology Strategy for Your Product?

Clinical pharmacology is an important cornerstone of the clinical development of drugs, which this blog post has only begun to introduce.  Future blog posts will focus on various aspects of clinical pharmacology, including the types of studies that comprise a clinical pharmacology program, a comparison of clinical pharmacology programs for large and small molecules, evaluations of drug interactions, and regulatory considerations for clinical pharmacology.

Blog Post

505(b)(2) Bridging Studies

While a 505(b)(2) NDA can potentially get a drug to market faster than a 505(b)(1) NDA, the choice of a bridging strategy to the listed drug is important and involves consideration of multiple factors.