Integration of Biomarker Validation in Oncology Trials
Recent case study highlights the importance of applying statistical rigor throughout the development and validation processes of biomarkers.
Immunomodulators and Cancer Research
Distinguishing CAR-T and CPI approaches and the clinical trial challenges and complexities associated with each.
COVID Exposes the Cracks in Trial Problems
While clinical trials are starting to make a return from COVID-19-related interruptions, cracks in their traditional operation are being exposed.
The RACE for Children Act Takes Effect This Month
An amendment to Pediatric Research Equity Act, as part of the 2017 FDA Reauthorization Act, goes into effect soon aiming to change the landscape and promote pediatric cancer drug development.
Designing Cell Therapies to Target Solid Tumors
A look at one company’s platform approach in enabling the engineering of T-cells to identify and destroy cancer.
Applied Clinical Trials, August 2020 Issue (PDF)
Click here for a link to open the Applied Clinical Trials August 2020 issue in an interactive PDF format.
The Importance of Biomarker Management
Exploring the benefits of capturing and integrating molecular biomarker data within clinical trials to build foundations for data assets.
Clinical Trials Can Duck the European GMO Problem
Amid the COVID-19 pandemic, the EU is allowing trials to start before the requirements of directives dating back as far as 2001 have been met.
Clinical Trial At-Home Service Providers
Firma Clinical Research CEO Michael Woods shares why COVID-19 may force greater efficiency for trial designs and greater access for trial participants.
News Notes
A compilation of recent notable news developments that pertain to the clinical trials industry.
Initial Design Considerations for Immuno-Oncology Trials
Perspectives and insights regarding regulatory considerations when planning and conducting immunotherapy studies.
Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs
The increasing need for treatments to slow the global spread of COVID-19 has prompted greater cooperation between drug regulatory authorities around the world.
Patients Are at the Heart of Cell and Gene Therapy
If you are an organization content with patient-centric approaches, you are behind. Today it is about patient-driven drug development.
