Aptiv Solutions is pleased to sponsor the upcoming Tufts CSDD executive roundtable focused on adaptive trial design best practices and challenges. Held at the Tufts University Dental School on February 13, 2013, an expert panel will discuss how adaptive clinical trials can be leveraged for greater scientific advancements and an improved development performance. The roundtable … continue reading
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Top Five Reasons Adaptive Trial Implementation Technology is Key to Success
Adaptive clinical trials (ACTs) dramatically improve the efficiency of the clinical development process for both drugs and medical devices. ACTs rely on the timely collection of data in defined interim analysis steps providing the opportunity for the trial to adapt to emerging data (i.e. real time learning). Importantly, these are not ad-hoc changes but are … continue reading
FDA Releases Adaptive Clinical Trials Best Practices Guidance
FDANews has released a new guide entitled the ‘Best Practices for Adaptive Clinical Trials‘ that is intended to help researchers and sponsors sync their specific trial models with those that the Agency has identified as ‘most valid’ over the course of the past several years. The ‘Best Practices for Adaptive Clinical Trials’ guidance covers topics … continue reading
Is Adaptive Monitoring Compatible with Pharma Quality Systems?
The complexity of clinical trials continues to grow as new technologies and treatment methods push the boundaries of what is possible in the health care industry. The challenges associated with monitoring clinical investigations has prompted the FDA to encourage the adoption of alternative monitoring solutions that are capable of ensuring the quality of the data … continue reading
Tufts Report Reveals Increased Pharma Interest in Adaptive Trials
Improving the efficiency of clinical trials has become one of the most important priorities for pharmaceutical companies around the world. In its annual R&D management report, the Tufts Center for the Study of Drug Development (CSDD) recently estimated the full price of bringing a new drug to market at over $1.3 billion. The report indicated … continue reading
Adaptive Clinical Trials Can Bring You “Beyond the Shadow of a Drought”
R&D production in the pharmaceutical industry has fallen more than 70% over the last 15 years, according to a recently published report, “Beyond the Shadow of a Drought: The need for a new mindset in pharma R&D,” by a group of analysts at the Oliver Wyman consulting firm. According to this insightful analysis, the underlying … continue reading
Welcome to Adaptive Insight, the Newest Blog by Aptiv Solutions
The pharmaceutical industry is in a state of change. Internally, companies struggle with spiraling development costs and demand for new compounds to fill the void left by expiring patents. Externally, they face the daily challenges of a global economy in crisis – reduced budgets, staff lay-offs, reorganizations, and off-shoring. Amid this change, one response that … continue reading
