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Finding Efficiency in Clinical Research

Centricity in Search of its Center (Clinical Researcher, June 2017)

Centricity in Search of its Center
Ronald S. Waife, as printed in Clinical Researcher
“Any unnecessary delays in drug development are a disservice to our patients (and few delays are truly necessary).”
Jargon comes from three sources:
  • to quickly express a concept in shorthand that would otherwise take too many words to express;
  • to protect professional knowledge and impress the ignorant;
  • and three, as a placeholder to fill the air until real thought and knowledge can fill the gap.
Jargon is only justified if it comes from the first impulse, and let’s assume for the moment that “patient centricity” is meant to be a justifiable shorthand.
 
Patient centricity has a cloud of obfuscation hanging over it akin to other neologisms like “pre-boarding” and “post-marketing”. (How does one board a plane before one boards a plane? If we are in post-marketing, haven’t we stopped selling the product?). Are there drugs we are developing that are not for patients? Are there trials we are doing that don’t involve patients? If not, then shame on us.  But perhaps what is meant is a matter of degree.
 
Jargon for Justification
Various players in clinical research are seizing on the patient centricity phrase to justify or promote concepts and products that, for the most part, have been with us for decades:
  • Patient centricity is the latest in a long line of frustrating attempts at justifying what should be obvious – gathering data on drug effects as close to the patient as possible. The original electronic patient diaries movement (constantly renamed as ePRO, eCOA, mHealth) continues to struggle for industry acceptance (inexplicably) and it is unlikely that a new turn of phrase will do the trick.
  • Patient centricity is a euphemism for another perpetual bugaboo – slow rates of subject enrollment in trials. Maybe this is a case of justifiable shorthand, if patient centricity means improving the practicality (from the subject’s viewpoint) of the trial protocol, or improved outreach to potential subjects, or more compelling reasons for trial participation.
  • Patient centricity is also being used, less admirably, as a way to express the chronic frustration sponsors have with their investigators, the implication being if we were only more patient-centric we could skip over those pesky investigators altogether. This is either a cynical method of selling new software or a shortcut around an important philosophical and scientific debate.
Patient centricity is supposed to mean we should care more about patients in protocol design, in data collection methods, in information sharing, and so on. Ok, sure. But some of this does not ring true: for instance, if we feel our investigators aren’t respecting, communicating, informing and sharing enough with the subjects in our trials, is this all the investigators’ fault? The history of clinical trial operations over the past 40 years has been the sponsors’ steady march away from the sites (not coincidentally simultaneous with the rise of CROs to do the work), and therefore away from the patients they see, so why are we surprised that there is a disconnect? 
We can’t ask investigators to be more connected to our subjects if we have disconnected from our investigators. Some of the efforts in the name of patient centricity seem to suggest we bypass those frustrating old-fashioned sites and get right to the patients. Why are we likely to do a better job centering on patients than we did centering on sites? In fact, sites have the best opportunity, knowledge and training to connect with patients. If we have failed the sites, let’s fix that and not just run after another elusive technology-plus-jargon fix.
 
The Center of Centricity
There is great value in patient centricity if we can find the true meaning of the term. If we have drifted from patient focus to profit focus, we need to correct that. If we have forgotten why we do clinical research, we must remember. If we have ignored the patient in pursuit of elegant statistics, or in fear of regulatory unpredictability, we have to fix this.
 
I propose a jargon-free understanding of patient centricity. It probably doesn’t mean you need new software or need to hire a “chief centricity officer”. It means re-examining, or even re-thinking, how we do clinical research to better serve our patients:
  • Any unnecessary delays in drug development are a disservice to our patients (and few delays are truly necessary). Clinical research remains widely inefficient at all sponsor companies and supporting CROs. Our tolerance for this inefficiency over decades remains baffling, and inexcusable. Centering on our patients includes eliminating the actions and activities that delay our drugs getting to market.
  • We should be more responsive to the needs of investigative sites, and more proactive in improving their performance in recruitment and quality data, or more thorough in questioning their continued participation. We should so the same in how we handle the data we receive and what we do with it. Some companies are beginning to realize the richness of already collected data in their possession, which both values more the contribution subjects have made by being the source of the data, and provides more knowledge to our companies and to medicine.
  • Everyone seems to recognize that study protocols are too often onerous for our patient volunteers, in time and travel requirements, in the number of procedures, and in paperwork. Like most improvements in study conduct, the realization of the need for simpler and more respectful protocols is trickling through the industry very slowly, despite the ubiquitous lip service.
  • Overall, as I have previously written, we need to ratchet up our collective sense of urgency. This may be the most useful and sincere way for the industry to express patient centricity. If we all care more about accelerating the timeline from discovery to marketing, and act as soon as we can on the next step in the process, we will do more for the patients who are waiting for our innovations than any other bundle of trendy concepts.
 

Patient centricity should mean doing a better job for patients, and doing our job better. Let’s not let jargon drain the meaning out of language: focusing on patients, if done correctly, could not be more worthwhile.

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