Getting approved therapies to patients faster that are better than the current comparator drug or the industry standard is the objective of every pharmaceutical company. While the goal is to shorten the drug development and testing cycle, regulators and payers are requiring additional safety, efficacy and tolerability data for a longer duration of time between therapeutics and the designated comparators. According to the KMR Group’s study of Phase II/III data from 27 companies, the trial duration has increased by at least 12 months within the past 10 years and the cycle times have increased exponentially as well.1
It also has been proven that large molecule trials (such as oncology studies) take years longer to complete than small molecule trials, which often is due to the slow enrollment process. With more room for failure in a lengthy development cycle, the focus on careful planning by the clinical supply team is becoming even more critical.2
By nature, comparators are more expensive than previously used placebos. As a result of the prolonged trial duration mentioned above and the increased price pressure from payers on commercial products, currently procurement teams are focusing on clinical trial cost savings because comparator cost can impact the trial budget significantly. Therefore, the estimate of the expected trial demand against the market availability is crucial for minimizing overage and avoiding out-of-stock situations. Once the trial starts, ongoing projections compared with actual results is essential for optimizing the supply of comparator, minimizing waste and ensuring sufficient comparator can be procured in the market. No one wants to leave a patient without their designated treatment, but minimizing the costs of comparator overage is a very wise way to cut costs.
By understanding the complexities of trial supplies, Fisher Clinical Services is experienced in identifying the constraints and evaluating the market availability of your comparator throughout the course of your trial. Utilizing the latest forecasting tools, our supply chain experts minimize overage and de-risk the clinical supply chain.
1 Cycle Time Reduction Remains Elusive Finds KMR Group’s Annual Cycle Time Trends Analysis, https://kmrgroup.com/wp-content/uploads/2015/08/2015_08_25_KMRGroup_CycleTimeTrend.pdf
2 “Large Molecule Clinical Trials Taking Longer, Costing More, Melissa Fassbender, Pharma.com, http://www.outsourcing-pharma.com/Clinical-Development/Large-molecule-clinical-trials-taking-longer-costing-more