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Blog Post
Clinical Trial Analysis Considerations for a Post-Hoc Overall Survival Endpoint
When analyzing overall survival in a post-hoc manner sponsors need to carefully consider the types of analyses to present and have a thorough understanding of both the regulatory precedent and market landscape which their product will enter.
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.
Blog Post
Statistical Design Considerations for Dose-Finding Oncology Trials
Since the introduction of the original 3+3 method, the available design options for dose escalation in early phase studies have expanded beyond traditional algorithm-based designs to include model-based designs.
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
Data Collection in Decentralized Clinical Trials
Information discussing the transition to DCTs and their challenges, alongside the integration of data collection technology and best practices for sharing DCT data.
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.
Blog Post
Nonclinical Considerations for Gene Therapy Products
The development of a gene therapy (GT) product has many considerations that differ from those of a traditional biologic or new chemical entity (NCE) program.
Blog Post
Analytical Method Quality Throughout the Pharmaceutical Development Lifecycle
For a drug to be used in a human clinical trial, analytical testing must be performed to demonstrate the suitability of the drug for use. These tests ensure the identity, quality, strength, purity, and potency of an active substance and drug product or biologic and must be scientifically sound and validated to demonstrate their suitability for the defined use.