Design for dissemination: Accounting for prescribing patterns
By: Christina Mack, PhD | August 26, 2016
What sponsors need to know to build effective, objective registries that best support their clinical research.
There has been much talk recently about the value registries can bring to clinical research. These online data platforms give patients and providers a place to record information about their condition and treatment that may not be available in a patient’s medical record, including how they were diagnosed, how their treatment is working, what non-prescription and complementary treatments they are using, etc. These data can offer vital insights into the broad patient experience that, in addition to knowledge gathered through the clinical trial, can better support trial results and help researchers understand the value and limitations of a particular treatment.
The challenge for biopharma companies is building registries that gather the right information from the right patients in the desired timeframe. As with any study, these projects face operational, logistical and methodological hurdles that have to be addressed during planning to ensure the registry delivers the quality and quantity of data sought.
To help industry stakeholders address some of these challenges, my colleague, Nancy Dreyer, and I are hosting a training program on registries and prospective cohort studies at the International Conference on Pharmacoepidemiology & Therapeutic Risk Management in Dublin, discussing how to design, execute and interpret data gathered in registries and prospective studies.
In the session, we’ll explore many of the regulatory, methodological and logistical challenges that organizations face when designing registries, along with best practices for avoiding common pitfalls. My section of the program focuses on considerations related to defining patient populations, including how to choose the right patients for your comparator group and how to reduce bias through patient selection, which are further outlined below. I also focus on new-to-market treatments throughout my talk, because we face additional challenges when studying these treatments that might rapidly disseminate, sometimes unevenly, throughout the patient population. With prior awareness and acknowledgement of these challenges we can work to reduce them through early planning.
These topics can be complex, but they are critical decision points that researchers need to factor into their study design strategies if they want the registry to generate robust, value-driven results.
These are just a few of the many factors that should be considered when building a registry or cohort study. It can seem overwhelming, but when pharma companies take the time to understand the intricacies that can impact study results and factor these issues into their design plan, they will build registries that deliver the greatest value in support of their research goals.
I look forward to seeing you at our session.