This full-day workshop on May 22 at the MD& East conference will provide an overview of new FDA guidance and initiatives from a product design perspective, with practical examples of well written design control documents to support successful 510(k) premarket notifications. The workshop will provide a discussion of regulatory and quality issues to address when … continue reading
Aptiv Solutions is pleased to sponsor and contribute to the upcoming Exploratory Clinical Development World Europe conference in London. On Wednesday May 23, Dr. Robert Miller, Chief Consultancy Officer and Product Development Consultant for Aptiv Solutions, will present “Biomarkers in Early Development – Faster and More Reliable Go/No Go Decision Making through Biomarker-Driven Population Enrichment”. … continue reading
Aptiv Solutions will attend the PSI Conference 2012, May 13 -16. The conference will include a joint day co-organized with the MHRA to focus on regulatory issues affecting statisticians and programmers within the pharmaceutical industry. Andy Grieve, Senior Vice President Clinical Trial Methodology, will participate in a roundtable discussion, “Benefit/Risk Analysis: Challenges to Implementation.” For more … continue reading
On occasion, medical device manufacturers have approached Aptiv Solutions and asked about the relationship between wireless devices and the Federal Communications Commission (FCC). Specifically, developers are curious about what role is played by the FCC in the regulatory approval of wireless medical devices in partnership with the FDA. While the FCC certainly does have jurisdiction … continue reading
The keyword for big pharma as the industry continues to move through 2012 is ‘savings.’ Pharmaceutical companies big and small are on the lookout for technologies and concepts that will allow them to improve efficiency, reduce costs, and maximize current investments while remaining competitive in an increasingly tight marketplace. Let’s take a look at the … continue reading
The flexible design of adaptive clinical trials offers sponsors significant efficiency gains and cost savings, as well as ethical benefits to patients. A potential downside of adaptive trials is their complexity, an issue that has in the past raised several concerns. In a survey on Adaptive Trials conducted in 2009, by Perceptive Informatics and Cytel, … continue reading
Phil Birch, Corporate Brand Manager for Adaptive Trials at Aptiv Solutions, was recently contacted by the Exploratory Clinical Development World blog in order to get his thoughts on what types of challenges drug companies are right now facing in the arena of clinical development. The interview that followed painted an illuminating picture of the current … continue reading
For anyone familiar with the amount of research, effort, and investment that goes into the development of a medical device in the United States, the idea of a ‘do-it-yourself’ design philosophy that addresses patient care cheaply and quickly might seem far-fetched. A recent CNN.com article, however, examines the work of the Little Devices group at … continue reading
Oncology clinical trials are driven by rapidly appearing discoveries of multiple oncogenic molecular alterations. However, the failure rate of oncology drug testing at the clinical level remains high. Between 2003 and 2010, only 34% of phase III drugs achieved statistical significance in their primary end points (http://www.ncbi.nlm.nih.gov/pubmed?term=22064459). By using adaptive design in oncology studies, sponsors … continue reading
Trial design can be an extremely complicated undertaking, particularly when it comes to the assumptions made regarding sample sizing. Even the most informed efforts to accurately predict the required sample size for a given investigation can in some cases create trials which are either under- or over-powered. It seems logical, then, to include a mechanism … continue reading
