As the conference company Cambridge Healthtech Institute celebrated the 10th anniversary of the Summit for Clinical Operations Executives (SCOPE) in February, BBK Worldwide recognized our participation in each of those ten events. For certain, the scale of the events’ educational topics, networking opportunities and corporate sponsorships have grown dramatically – as has the number of attendees from 200 in 2010 to nearly 2,000 in 2019.
What struck me was what hasn’t changed. The role of the patient as a key stakeholder in clinical trials remains a topic of discussion – as if this is still a question. The challenges of patient recruitment continue to be lamented. And new companies tout the idea of matching patients to trials through tech-enabled services as if these are new concepts. “Newly diagnosed patients turn to the internet for information about their conditions,” we were told as if being given a gift of infinite value. Delays in study start-up remain a problem, while analyzing study metrics in real time remains an untapped opportunity for improved enrollment.
The keynote sessions delivered on inspiration, innovation, and compassion. We witnessed first-hand how talking about one’s experiences and hopes led to emotional, even cathartic, moments for the speakers themselves.
- Will patient reported outcomes someday be collected via Alexa or Siri?
- How will patients’ experience within a clinical trial change their expectations of the healthcare delivery and payment system as a whole?
- What do we owe the caregivers of study participants?
It was exciting to see a new generation of leaders at the speaker’s podium. And, surprising to see a new generation of clin ops professionals with a limited understanding of the nuanced relationship between a study protocol and the patient recruitment, engagement, and retention for that study.
After SCOPE, I drove across town to participate in an Investigators’ Meeting – a juxtaposition that added more color and context to my observations of the week. We shared ideas about improving the patient experience in clinical trials in both settings – yet often deferred applying these concepts to some undefined future project. We heard from patient representatives in many sessions at SCOPE, yet not during the IM. At both meetings, we found a wide range of experience, confidence, and success among participants with respect to patient engagement – making it difficult to achieve shared commitment in how to address enrollment challenges for the study staring us in the face.
At the end of the week I landed where I often do – reminded of the days when patients weren’t patients, when investigators couldn’t enroll from their own panels, when scientific progress was measured in decades instead of months, and when rare diseases had but one or two advocates among pharmaceutical companies. As each of these levers moved, the ways and means to successful patient enrollment and engagement were impacted – often making it easier to find and speak with potential participants. And, equally as often, made more difficult by increased competition and study complexity. There is no question that this is not the clinical research environment of 2019.
Today, our clinical teams are comprised of members of a generation that demands documented proof that innovations work alongside members of a generation who learn more by doing, than by reading. More companies than ever – with their unique cultures and approaches – are now collaborators on every study. Science moves so quickly that it’s a rare clinical trial that doesn’t face competition from a newly approved compound or a newly initiated study within months of enrolling its first patient.
Despite the fact that we work in a field that demands uniformity of execution within a protocol, clinical operations professionals must continue to innovate, tweak, trial, measure, modify, and invest in the strategies and tactics that deliver the kind of patient experience that our study volunteers require – and deserve.