Historical data is important in clinical trials as it provides valuable insights into patient populations, treatment outcomes, and potential safety concerns. It can also help inform trial design, patient selection, and identify trends and patterns in patient data, ultimately leading to more efficient and effective clinical trials.
However, there are challenges associated with using historical data in clinical studies. For example, the data may be incomplete or outdated, or not applicable to the specific patient population being studied. This requires researchers to carefully evaluate and validate the historical data before using it in clinical trial design and analysis.
“Most companies conduct at least some form of feasibility testing on their trial designs because they know that changes and miscalculations can cause delays and cost money,” write Parexel Senior Director Alan Scott and Vice President Denis McMillan. “For example, the direct cost to implement a single protocol amendment averages approximately $500,000 in unplanned expenses and adds 61 days to project timelines.”
Discover how these challenges can be overcome so that clinical trials can reap the benefits of historical data.