Combined Phase Trials combine all phases of a clinical trial. They go from one clinical trial phase to the next, seamlessly, saving money and time. They also reduce time and cost of conducting the study. (Also known as “Adaptive Trials”)
Part of Combine Phase Trials is Master Clinical Protocol which is a new kind of clinical trial proposed by the FDA. It’s revolutionary in that you can look for multiple indications of the same drug in teh same trial. Traditionally you had to do different clinical trials for one indication.
MCP allows you to write one large protocol and each individual use fo the drug can be a subset. Data can be pulled from each subset rather than closing the study. It looks like a many trial program with the trials merged into one. It also allows you to test multiple drugs for the same disease as you don’t know which drug will work better. Each drug is a subset of the large clinical study. The FDA is pushing many pharma companies to use Master protocols to speed up drug development.
The key challenges for managing these types of clincal trials are very different from conventional clinical trials. They require a lot more project management resources. They are very hard trials to run in that there are so many variables. They require a lot more automation and technology as they could easily fall apart.
They require a lot more automation and technology as they could easily fall apart.
Project Management using automation becomes very critical. The project manager has to run it properly or it could lead to much loss.
DLTA helps in the planning, administration and execution of clinical trials. Drug Lifecycle Tracking Application maps the end-to-end drug approval process. It offers a one stop shop to manage Drug Lifecycle and Regulatory Review process. Call us at (240) 753-8282.