While important, clinical trial protocols merely provide the foundation for success. It is the people who run those protocols, and their use of optimal processes and systems, that determine whether ...
Protocol design does not struggle in the protocol. It struggles in the transition to trial, when assumptions embedded in the ...
The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...
When discussing the future of clinical trials, people often focus on the promise of exciting new technologies, including artificial intelligence (AI) and predictive modeling. However, even the most ...
Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according to a recent paper ...
In the second of a two-part article, Gabrielle Faure-André and Stéphanie Garçon at Santarelli unpick EPO, UPC and French case law to assess the importance of clinical development timelines in ...
The lack of a mechanism to measure the workload involved in a clinical trials protocol was identified and confirmed by a literature review. To collect information on how Ontario sites were assessing ...
In the first of a two-parter, lawyers at Santarelli analyse the patentability of therapeutic inventions where publication of clinical trial protocols occurs before the application's filing date The ...
Despite being a cornerstone of cancer treatment advancement, clinical trials remain inaccessible for many patients because of structural, socioeconomic, and systemic barriers. In this ...
Clinical trial reporting standards and guidelines constitute a structured framework to ensure that the design, conduct, analysis and results of health‐care interventions are communicated with clarity, ...
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