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
The May issue of Consumer Reports contained an article titled “Dangerous Devices” laying bare what it claimed was a culture of unsafe medical device approval practices entrenched at the FDA. In particular, Consumer Reports focused on the concept of substantial equivalence in the 510(k) regulatory process – coupled with anecdotal and statistical evidence regarding device … 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
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
