Drug Companies Expand Responsibilities for Phase I Strategy Development

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--The decision to move investigational drugs to Phase I testing is no longer in the hands of pre-clinical development executives, according to a new study from Cutting Edge Information. Drug companies are currently pulling multiple departments together to develop critical Phase I strategies.

“Whether it’s the clinical, pre-clinical, or a partner company, these milestones ensure funds aren’t wasted on a compound that could be considered unsafe or impractical.”

The study, “Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase I Trials,” found that several surveyed pharmaceutical companies involve toxicologists and physicians in their approval boards’ decisions to move compounds into Phase I. At one surveyed company, even more collaboration exists; experts from both pre-clinical and Phase I clinical groups examine the clinical data before deciding whether to move a compound forward in the process.

“We found that not only are companies collaborating across multiple departments, but they are also setting more innovative milestones for these drugs,” said Ryan McGuire, research team leader at Cutting Edge Information. “Whether it’s the clinical, pre-clinical, or a partner company, these milestones ensure funds aren’t wasted on a compound that could be considered unsafe or impractical.”

Once a drug or compound has passed these series of milestones, a company will fully commit to investing in large-scale toxicology studies and manufacturing campaigns. The blend of both the criteria markers and the collaboration of experts across multiple departments allow companies to not only determine drug safety in humans but also ultimately valuable to that company. This combination of thorough checks and balances also simplifies the final approval process as the compound has already fulfilled important benchmarks.

“Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase I Trials” (http://www.cuttingedgeinfo.com/research/clinical-development/clinical-pharmacology/) examines and defines the critical cost drivers when budgeting for Phase I clinical trials. Research also benchmarks planning considerations including clinical team structure by analyzing data collected from dozens of Phase I clinical trials. Use this report to:

• Save time and prevent costly delays with early strategic planning of Phase I trials.
• Balance the number and quality of trial sites during site selection to manage patient enrollment and drop-off rates.
• Manage critical cost-drivers, including the number of patients and required patient visits, when budgeting for Phase I trials.
• Explore data sets for 12 oncology Phase I clinical trials

For more information about Phase I clinical trials and their critical cost-drivers, contact Cassie Demeter at 919-403-6583.