This year’s SCOPE conference in Orlando, Florida brought together some of the brightest minds in clinical trial planning, management, and operations. While many of the topics presented warranted in-depth discussion and focus, our team observed that a few themes resounded as collectively important:
In general, everyone observed that velocity of data is increasing throughout the clinical trial cycle.
This includes every step from planning through to submission. As we manage ever-more complex trials, our reliance on eClinical tools increases. Each tool is collecting data at the speed of light and, when taking into account the sheer number and diversity of sites, one can agree that the old way of doing things is no longer sustainable. This amazing and sudden increase in trial data “velocity” no longer permits us to perform traditional data verification steps such as SDV and alike in a way that will not impede the trial.
Paper must be eliminated!
In years past we focused on eSource and this year several vendors offered very cool tablet-based implementations. This “Digitization of Clinical Trials” trend will continue and it is incumbent upon everyone in a trial operations leadership position to carefully consider assembling an appropriate suite of eClinical tools for the conduct and execution of their studies. In addition to this increase in data volume and speed, a challenge facing those in ClinOps 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.
“Subjects” are now “Patients”.
All panelists and speakers were careful in referring to “subjects” as “patients.” Indeed, it was refreshing to see patient advocacy groups sharing the podium and panels along with clinical operations executives. Instead of viewing each individual participants as a faceless, de-identified, randomized record, major players in industry are striving towards and considering people management as a significant ingredient of study conduct. For example, Pfizer has embarked on a multi-year project with focus on patient engagement.
Patient engagement is critical in studies.
Our industry is being affected by the independence that patients are enjoying in picking and choosing their therapies as well as the level and extent of their participation in trials. To this end, it has become increasingly important for us to focus on the softer side of people management and become our participants’ patient advocates. Even though we are still experimenting and collecting data, we realize we are in a partnership with “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 legal 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. It is time for the rest of us to follow.
A thoughtful Approach to Innovation and transforming Pharma from Manufacturing to Service is needed.
This resonates quite well with the realities of our industry. Instead of viewing ourselves as makers of drugs and looking for innovation in optimizing production, six sigma, lean manufacturing, just-in-time supply chain and alike, we need to begin looking more specifically at the therapies that we are working on and how to optimize outcomes –rather than just making the pills cheaper!
Innovate like Silicon Valley – but carefully!
Being a technology company, notion of “ease of use,” “minimum viable product,” and “course corrections” in product trajectories are second nature to us, but to hear those transposed to our industry was refreshing. Although, one might feel that certain “free-wheeling” product development concepts emerged from an era and an industry (Internet/ Web Software) that was wide open and not accountable to any regulatory body and finally was fairly safe–no serious harm would come from a bad idea! Of course, we wouldn’t think of picking on the speaker just because his slides presumptuously showed Tom Brady as Super Bowl MVP (he apparently – like many others- projected the wrong outcome for the Super Bowl when he submitted his slides – Go Eagles!), but the reality of ongoing systems validation and rigors of compliance that are required by us to show efficacy and safety BEFORE we embark on a project runs totally counter to the parameters within which Silicon Valley operates. Nonetheless there are parallels where we can learn from Silicon Valley; there is no substitute for teams with deep experience in our industry. Proceed with caution – plan ahead, but be flexible.
We look forward to seeing how these important topics evolve into exciting developments in culture, technology and practice within in our industry. Until then, off to our next adventure: 7th Annual Clinical Data Integration & Management Conference in Princeton, NJ—March 20 & 21, 2018! We hope to see you there.
Were you able to attend SCOPE in Orlando this year? Click here to share about your experience. We’d love to compare notes!