In general, everyone observed that velocity of data is increasing throughout the clinical trial cycle.
This includes every step from planning through to submission.
Paper must be eliminated!
The volume and speed at which data is collected, distributed and aggregated no longer permits us to perform traditional data verification steps such as SDV and alike. The “Digitization of Clinical Trials Trend” will continue although in many ways and dispensing with paper will prove difficult. Further exacerbating the problem will be the fact that not all vendor tools are created equal and that once everything goes digital, plans need to be laid for allowing all these systems to talk to each other.
Coupled with the Digitization trend, or perhaps the impetus for Digitization, is a predominant focus on innovation.
Pfizer, for example, has embarked on a multi-year project with focus on Patient Engagement. Incidentally – referring to “subjects” as “Patients” was another major trend. Our industry is being affected by the independence that patients are enjoying in picking and choosing their therapies as well as level and extent of their participation in trials. To this end, it has become increasingly important for all of us to focus on the softer side of people management and become patient advocates. Even though we are still experimenting and collecting data, we are realizing that we are in a partnership with our “subjects” and not in full control. The ripple effect of this change in attitude is affecting how trials are organized and conducted and is even requiring some to reconsider and revise their agreements to reflect this change. Kudo’s to big pharma for expanding patient engagement from the marketing side of the shop to the research side!