Expansion of Clinical Trials

Interesting news post on how the increase in clinical trials studies is driving the outsourcing business. Lots of new businesses benefiting and building long term relationships.

Phase IV Clinical Trials Outsourcing Booming to Meet Larger Goals, Finds Cutting Edge Information

Third-Party Work with CROs Depends on Trial Type and Sponsor Ability

RESEARCH TRIANGLE PARK, N.C., Apr 23, 2012 (BUSINESS WIRE) -- The rapid growth of Phase IV clinical trials has meant expanded budgets for post-marketing studies and a subsequent need to manage complex outsourcing relationships.

Interviews and surveys for Cutting Edge Information's study, "Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management," found that a pharmaceutical or biotechnology company's decision to outsource a Phase IV research project depends largely on the trial type and company infrastructure. "Strategies for managing Phase IV outsourcing are carefully tailored to meet each company's needs," said Adam Bianchi, chief operating officer at Cutting Edge Information. "Phase IV teams have to decide what they need to do internally and what can be outsourced for greater productivity."

Executives reported a wide variety of Phase IV strategies and structures in place:

-- The largest Phase IV outsourcing at a single company was 100 percent for its registries and observational trials; another company reported spending 10 percent or less for all types of Phase IV trials.

-- Safety trials have the highest average percentage of clinical trial budget allocated to outsourcing at 68 percent.

-- Expanded access programs have the smallest percentage of budget allocated for work with CROs and third-party specialists. These trials average only 30 percent of budget allocated for outsourced activities.

"The variance in clinical outsourcing shows that there is not a 'right' way to manage Phase IV trials," said David Richardson, research team leader. "Outsourcing Phase IV work is a choice that largely comes out of a combination of each company's ability to conduct these trials internally and their preference to do so."

"Phase IV Clinical Trials" ( http://www.cuttingedgeinfo.com/research/medical-affairs/phase-iv-clinical-trials/ ) includes benchmarks for per-patient cost, patients-per-site, patients-per-investigator and other key metrics for five types of Phase IV studies in seven therapeutic areas. The study supports Phase IV teams by:

-- Detailing real-company structures and clarifying Phase IV team roles

-- Tracking per-patient budgets and headcounts by trial type, region, and company size

-- Exploring the metrics companies use to track performance and drive improvement in Phase IV operations

For more information about Phase IV clinical trials and medical affairs management, visit http://www.cuttingedgeinfo.com/research/medical-affairs/

SOURCE: Cutting Edge Information



     
        Cutting Edge Information
        Elio Evangelista, 919-403-6583