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

Clinical Trial Drug Formulations

Companies that provide clinical trial materials can produce them in a variety of formulations, including tablet form, gel capsules, liquid solutions, semi-solid solutions and sterilized solutions for intravenous use. These clinical trial materials may be packaged in a variety of methods, using whatever type of packaging is most appropriate. Depending on the type of studies that the clinical trial materials are intended for, the packaging may be clearly labeled or left completely blank. When the packaging for the materials is left blank, the materials are placed in bulk within larger containers that are clearly labeled. These materials are useful for blind or double blind clinical trials and are effective in keeping the contents of the materials private to prevent accidental transmission of information meant to be kept private. Should clinical trial participants accidentally be exposed to excess information, the trials may be compromised, skewing the results of the trial and possibly negating the trial.

Shopping for Bulk Pharmaceuticals for the First Time

As someone with a very low personal medication budget, I’ve never spent more than $10 on medicine at one time. Suddenly, my position requires me to purchase the medical supplies for an entire youth camp’s nursing station and its first aid kits. $200 purchases were not unusual. Factors such as expiration date, quantity and storage-effectiveness came into play when before my only concern was cost.

The shopping experience is very different which shopping on this scale. On a very basic level, it becomes necessary to be aware of a much wider range of drugs, including a large number of pediatric medications. With this awareness comes an awareness of nuance: How will the kids react to taking this medicine? How does it need to be stored/administered? Does it come in delicious flavors that aren’t delicious enough to be a liability?

Cost was another strange consideration. When previously it had been only the final cost that mattered, now the cost per dose was the crucial consideration. In these situations, packaging became less important, and my attention focused on the unit prices conveniently provided on the price tags. Sales and clearance prices were particularly appreciated.

The cart becomes more and more full. One would think that purchasing through a catalog would be simpler and cheaper, but experience showed that the convenience and low cost of our nearby bulk pharmacy was equal if not sometimes better.

The needs of both adults and children were crucial to the process. Sure, a huge canister of cold and flu medication or liquid pain reliever was the cheapest option, but experience told me that many kids are only allowed to take certain types of pain relievers. Parents have specific wishes for the medication of their children, and by being mindful of these needs and offering a diverse selection of medications, these parents’ worries may be put to rest, knowing we will take good care of their kids.