Approval delays can cost pharmaceutical companies years in development time and potentially millions in lost sales, which is why it’s critical to have all the right capabilities clearly defined early in the drug development process. Without the inclusion of a statistician during the planning phase, your new drug or medical device could be doomed. A statistician will help ensure that you excel in the following areas:
A statistician can help the team determine which trials to conduct and how to conduct them, without putting more subjects at potential risk than necessary. Working closely with the clinical and regulatory teams, skilled statisticians find ways to shorten improve the development cycle and cut trials short that are either obviously failing or overwhelmingly successful. They leverage the latest thinking in adaptive designs and, when appropriate, they use and combine data from multiple trials to boost power.
When it comes to trial design, statisticians consider the vast array of study designs, even those from different fields, to recommend the best method for the project. In one recent example, when a company could not find a way to test the efficacy of a new target therapy, input from a statistician led the company to use a standard oncology trial methodology, which ultimately changed the way pain trials are designed.
In clinical trials, regulators look for data integrity, end-to-end, from trial data source to report. Having a statistician on the team means that you can be assured someone is paying close attention, using analytics to search for potential errors or fraud, and helping to ensure the data is clean and stands up to regulatory scrutiny. Trials that don’t include these checks and balances run the risk of receiving “approvable” letters, requiring the team to clean databases, re-run analyses and rewrite reports.
Statisticians can also provide value by recommending different methods for testing data, to ensure the results are solid under various testing scenarios. This can preempt requirements for additional testing, helping companies avoid further costly delays.
No pharmaceutical company wants to experience unnecessary delays in the drug approval process. By including a statistician from the early planning stages, companies can shorten the development cycle, use the most appropriate trial methodologies, be assured they are working with clean data that withstands regulatory scrutiny, and ensure results stand up under various testing scenarios.