Understanding where real-world data can make a real difference
Let’s take a closer look at a few examples where real-world data can have a real-world impact on clinical trials. Optimizing trial effectiveness is one of the best use cases for real-world data in trial development. Studies have shown that the majority of all clinical trial protocols need to be amended, frequently because, as written, the protocols limit the potential pool of participants by a significant amount. For example, imagine that you’re a CRO conducting a trial of a new medication. If the protocol specifies that participants cannot have hypertension as a comorbid condition and 80% of patients in the field of study have hypertension, you know you need to either expand your field of search or plan for an extended period of enrollment to account for the large number of ineligible participants. In this case, real-world data could help you identify geographic regions where the incidence of hypertension is lower to reach the requisite number of participants.
Prescription label expansion is another compelling use case for real-world data. As pharmaceutical companies look to expand FDA approval for additional areas of treatment, real-world data can help identify new groups that might benefit from the drug treatment and even identify patients outside the traditional audience who are already receiving (and benefiting from) the drug treatment. The classic example here is the use of real-world data/evidence to support the use of palbociclib in males with breast cancer.
A third use case is the creation of external control arms for clinical trials. Oncology departments in particular have found real-world data to be effective in creating accurate control arms. The data used in external control arms must closely match other sample populations and often requires highly detailed information, which a CRO or trial sponsor may not have within their own data sources.
It's important to remember that, while integrating real-world data into the clinical development process has the potential to be a game-changer for CROs, it is not a panacea that will eliminate all challenges from the trial development process. Companies still need to do their due diligence in selecting the right data choice and data vendor, a decision that will ultimately be driven by the trial design itself.
So, what should you be looking for in a real-world data solution? Read my next blog to find out.