RESEARCH TRIANGLE PARK, N.C.--(EON: Enhanced Online News)--Many pharmaceutical companies leverage experts from different aspects of product development for a drug’s approval discussion, found a recent study by Cutting Edge Information.
“Phase I Clinical Trials: Optimizing Cost-Drivers for Clinical Pharmacology Programs”
“Phase I Clinical Trials: Optimizing Cost-Drivers for Clinical Pharmacology Programs,” includes an interview with a pharmaceutical company executive who explains how a board — consisting of physicians, toxicologists, and other pre-clinical executives — makes the decision to move a compound from the pre-clinical phase to Phase I. Board members assess the drug’s safety before allowing it to advance. If the decision is made to move forward, this group sets dosage limits based on animal toxicology data compiled up to that point.
Another company’s clinical director described a similar process. A team with diverse expertise within the discovery group assesses a compound to determine whether further trials will be valuable to the company. To be considered, a drug must pass through many checkpoints in the pre-clinical trials, either defined by itself or by a partner company. At the point that a candidate compound is approved and moves past the pre-clinical stage, a new development team will take control.
Some companies establish milestones that all compounds must pass before reaching Phase I trials. A clinical trial manager describes a stage-gating system in which a compound must meet requirements set by the clinical team. This system allows companies to save time and money by discarding compounds as soon as they fail to meet a development requirement.
“A stage-gating system that determines a drug’s forward progress is done so compiling data by the pre-clinical team with early product quality assessments and the protocol synopsis contributed by the clinical team,” said Ryan McGuire, research team leader at Cutting Edge Information. “A board assesses this information and makes the final decision. The clinical trial manager acts as clinical liaison during this process”.
“Phase I Clinical Trials: Optimizing Cost-Drivers for Clinical Pharmacology Programs,” (http://www.cuttingedgeinfo.com/research/clinical-development/phase-i-clinical-trials/) examines the critical cost drivers when budgeting for Phase I trials. Use this report to:
- Manage critical cost-drivers when budgeting for Phase I trials.
- Save time and prevent costly delays with early strategic planning.
- Balance the number and quality of trial sites during site selection to manage patient enrollment and drop-off rates.
For more information about Phase I clinical trials, contact Cassie Demeter at 919-403-6583.