Digitalization has revolutionized an industry once reliant on paper collection.
Observing the many digital applications available nowadays to assist in data generation and collection in the field of clinical research, has made me reflect on how differently we did this in the past. When I started my career in the industry as a clinical research physician in the early 1990s, paper was the norm. Most clinical studies’ data collection took place on paper. Investigators would fill in case report forms (CRF) using triplicate (or sometimes quadruplicate, depending on the appetite of the sponsor), which clinical research assistants would tear, distribute to the various study folders and carry back to the office. Besides the medical information included in the CRF, paper was also the primary tool for most of the patient-reported outcome data.
If you were working in a disease area where one could not rely on any objective measures (eg: glycemia) but rather where the primary outcome measure for your trial was based on symptoms reported by patients on a daily basis, then you had to rely on paper collection.
That is until providers began to develop digital tools that could be programmed to collect specific data, at a specific time, and provide a time stamp for data entry.
Read more on Pierre’s reflection in Applied Clinical Trials Magazine