Imagine this: Later today, in Room 6A at the San Diego Convention Center, Valeria Santini, MD, stands in one corner, representing laboratory scientists, and Justin Taylor, MD, stands poised in the other, prepared to defend clinicians in the great debate. Does either really care? Does the laboratory scientist care about the patient burden incurred with laboratory correlates in clinical trials? Does the clinician care that the laboratory scientists are doing everything possible to help bench-based triumphs become bedside victories? The gloves are off, and the debate is on: Bench meets bedside in a fight for the ages. Of course, we all know even before the fight begins — before the pulses rise and the breathing quickens in anticipation of a formidable battle — the result will be a draw. None of us would be invested in this work if we did not care. However, prior to the main event, I reached out for a different (and, perhaps, the most important) perspective: the patient’s perspective. So, tell us, Patient X, who really gives a care?
Understandably, I will keep Patient X’s identity anonymous, but imagine a young mother with two precious children, hearing the news of her blood cancer diagnosis as people around the world ring in the New Year. She is smart. She is strong. She is brave. And she will live, doing whatever it takes to make it so. She has now walked the journey from diagnosis to treatment to trial consideration to remission to living without cancer, but what does she think about whether the laboratory scientists or the clinicians care. To begin, we established that she feels “very good” about clinical trials. “Being on a trial feels like you are on the leading edge of new medicine and treatments,” she said. She went on to explain that she understood very quickly that she had a complicated diagnosis and fairly poor prognosis. “I very much wanted to be treated with the ‘latest and greatest,’ even if said treatment had not yet gone through full Food and Drug Administration approval.”
When contemplating enrolling on a trial, she did not consider the laboratory requirements a burden. “It felt like nearly all of my laboratory draws that were for trials were done at the same time as my regularly scheduled labs,” she shared. “So, it really wasn’t a burden to have a few extra vials drawn for the purpose of the trials.” However, she conceded that had there been frequent additional lab draws that were exclusively for the trial, “then I may have had an issue with it.” Though she acknowledged she did not give laboratory requirements much thought while on trial, she has since become more interested in her results. “I’m not sure if I’m allowed to be privy to those results, and perhaps there is a good reason why not, but I can’t help but be curious about it.”
Could we demystify laboratory correlates in trials? “I knew that my disease was a tricky one, and that the doctors and clinicians believed that the trials may be able to help me,” she said. “Frankly, if I had known everything there was to know about each trial I participated in, I may have been less hopeful about their potential efficacy. So, a little bit of mystery was not a bad thing in my case.”
And finally, how can the laboratory scientists and clinicians design trials better? “I felt (and still do — perhaps naively so!) that that aspect of the process was in the right hands with the doctors, clinicians, and researchers,” she responded. Patient X trusts the clinicians and researchers to design trials with transparency and thoughtfulness. To do that well, working together is key.
Ultimately, that is what this session is all about: Bringing clinicians and researchers together and concluding that both laboratory scientists and clinicians care, and that they care deeply. A key takeaway is Dr. Tayor’s message to patients: “Laboratory scientists do not see patients as experimental models. We understand that this is probably the most difficult time in their lives, and we want to ensure that the sacrifices they make by enrolling on a clinical trial are put towards the best use.”
He added, “The goal and central message of the session is to bring these two groups together and help each one understand the other’s point of view and come up with ways to compromise and work together to more successfully develop new drugs for our patients, where we maximize the information we learn from each patient enrolled.” Ideally, clinicians and laboratory scientists must engage in trial design together to align the pertinent elements from the bench and the bedside. This symbiotic merger will serve to enrich what we learn from trials and, ultimately, enhance the patient experience.
Dr. Ragon indicated no relevant conflicts of interest.