Aptiv Solutions is pleased to sponsor the Informa Lifesciences Clinical Operations Summit, May 23 to May 24, in Brussels. On Wednesday May 23, Corey Dunham, Senior Vice President, Global Data Management, will present “Designing an Integrated Technology Platform for Implementation of Adaptive Clinical Trials. He will discuss designing a technology system that meets both FDA and … 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
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
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
We are pleased to announce the latest release in the Aptiv Solutions proprietary suite of adaptive trial software: ADDPLAN® 6.0 PE, specifically developed to support adaptive design and simulation for population enrichment (PE) trials. Click to read the recent press release. Why Use Patient Enrichment? There is a growing interest among regulators and sponsors in … continue reading
Cost savings are far from the only benefits associated with adaptive trials. From an ethical perspective, adaptive designs offer an appealing answer to the quandary that has faced investigators since the very first clinical trials were inaugurated: justifying the continued dosage of a patient population with a treatment that has been shown as ineffective mid-way … continue reading
