An analysis of the use of time sampling strategies (subject reports of medication dosing behavior in the period preceding a study contact) compared to daily subject diaries in two Actual Use Trials conducted by PEGUS Research was published in the journal SelfCare. The analysis concluded that for products with a simple dosing regimen, time sampling is simple, has far fewer missing data points than diary data, is less intrusive, and thus may be better than diaries for an AUS. Russell Bradford, Brent Page, Kimberly Anderson and Tera Smith were contributing authors from PEGUS. The sponsor of the two studies and the subsequent analysis of methodologies was Boehringer Ingelheim Pharmaceuticals, Inc. The abstract and link to the article (Assessment of Use in Actual Use Studies: Time Sampling or Diary Data?, Bradford, R.D., Page, B.C., Anderson, K.A., Smith, T., Wruck J., SelfCare 2019;10(1):26-37) can be found here.
We are pleased to continue to partner with industry to contribute to the growing literature around prescription-to-over-the-counter switch research. We hope that these ongoing efforts will add to the understanding of how Rx-to-OTC switch research can be done, and the implications of study design decisions.