A failed phase 3 drug trial is one of the worst possible outcomes for a pharmaceutical company and for patients, both in terms of financial resources spent as well as time sunk into an unproductive research path. A recent article published by Roche describes how that company had to deal with several recent Phase 3 disappointments that were able to inform key biological concepts surrounding the drugs in question, but which didn't produce a viable product that could then be marketed.
Missing from the article is specific detail on the trial design methodology used to study the drugs in question. It's not [...]
Adaptive clinical trials offer a host of benefits when investigating both drugs and medical devices. By making use of a single technology platform that flexibly and seamlessly combines electronic data capture, randomization and supply management, sponsors are able to more efficiently and easily manage the critical aspects of adaptive trials.
In this podcast, Corey Dunham, Senior Vice President for Biometrics at Aptiv Solutions, and Michael Remavich, Senior Director of Clinical Data Management at Aptiv Solutions discuss technological innovations that allow sponsors to design and execute adaptive trials. [...]
The first ADDPLAN DF Consortium has recently convened, co-founded by Aptiv Solutions and three top global pharmaceutical corporations, including Novartis International AG, Janssen Pharmaceuticals, Inc., and Ely Lilly, Inc. Progress will break exciting new ground for the development of sophisticated adaptive design technologies essential for effective dose-finding trials in exploratory clinical development.
The average rate of failure in phase III pivotal trials is fifty percent. This is largely due to poor dose selection, too few, and too narrow a range of doses in phase II. The ADDPLAN DF Consortium [...]
Centralized endpoint adjudication is becoming increasingly important from a regulatory perspective, with both the FDA and the EMA providing commentary and guidelines in recent years. Understanding the advantages of centralized endpoint adjudication in a clinical trial, as well as the potential offered by software such as Aptiv Solutions AptivEndpointTM in combination with a central Endpoint Coordinating Center, is crucial to effective trial data management.
In the podcast below we speak with Gene Resnick, MD, Chief Medical Officer at Aptiv Solutions, and Angela Silverman, MSN, CANP, Manager of Clinical [...]
Aptiv Solutions senior vice president of Software Development, Dr. Vladimir Dragalin, Ph.D., was recently interviewed by Technology Networks on the subject of adaptive trial design. Specifically, Dr. Dragalin discussed the Aptiv Solutions ADDPLAN® software, a tool that has been designed to assist with the planning, simulation, and evaluation of adaptive clinical trials. With the FDA having recently purchased ADDPLAN® software licenses, and the recent surge of interest in adaptive trials across the drug development industry, ADDPLAN® is poised to play an even more important role in clinical research in the [...]
A recent article in Life Science Reader discussed the approach taken by drug manufacturer Eli Lilly in reconsidering its future development strategies. Of particular interest was the admission by Lilly's chief medical office, Dr. Timothy Garnett, that the challenges and failures faced the company in Phase 3 trials are symptomatic of an industry-wide need to refocus on trial strategy and planning.
Specifically, Dr. Garnett references to the current practice in the industry where many drug companies enter into Phase 3 of a clinical trial without having performed the proper experiments. As a result, [...]
Clinical on-site monitoring employing 100% source data verification (SDV) is one of the largest drivers of the costs of a clinical trial. Although alternative monitoring strategies involving reduced SDV (including risk-based monitoring) have been proposed for several years, these strategies have not yet been widely adopted across industry. The primary reason for low adoption appears to be lack of clarity from regulatory authorities as to what constitutes sufficient and acceptable monitoring.
Regulatory authorities have recently released specific guidance on the acceptability of alternative monitoring [...]
Vicki Anastasi, Senior Vice President of Aptiv Solutions, sat down this past week with Brett Johnson of OneMedRadio to discuss innovative approaches to trial design. Vicki touched on adaptive trial designs as well as risk-based monitoring, and explained the benefits offered by these advanced investigatory techniques. Listen to the full interview below for an in-depth look at where the future of clinical trial design is headed.
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Adaptive trial design received a major profile boost this month with the announcement that not one, but two breast cancer treatments involved in the I-Spy 2 clinical trial showed promising results. I-Spy 2 is not just an important trial for advancing the fight against breast cancer, but it also serves as a showcase for adaptive trials and their ability to improve drug development decision-making versus more traditional trial designs.
I-Spy 2 enables sponsor companies to rapidly identify drugs that have the best chance of efficacy for pre-specified sub-populations of breast cancer patients by using an [...]
Adaptive clinical trial design isn't just adept at reducing the economic burden on pharmaceuticals companies investigating a new drug. This type of trial is also a versatile tool that can be used as a novel approach when considering treatments for challenging diseases that have resisted traditional clinical trial methodologies. This is well illustrated when examining the application of an adaptive clinical trial design in the search for an anti-hepatitis C therapy.
The genotype variance in the hepatitis C population – estimated at 150 million worldwide – comes with a concomitant range of response to [...]