I am a practicing OBGYN in Dallas Texas in a large private group with a generalist focus. We have a reputation for high volume obstetrics and minimally invasive gynecologic surgery. I don’t have a background in research, I know absolutely nothing about pharmaceutical development, and I would be horrified if forced to demonstrate my ignorance in speaking, even for a moment, about the mathematic algorithms which the Aspen team have developed. As a physician, what I do have is a deep appreciation for what the biomedical industry has done to advance my ability to diagnose and treat patients in their moment of need. What I also have is a respect for the magnitude of time and expense which it takes to bring essential drugs to market; an impediment which is quite obvious to all of us who practice medicine.
I have been consulting with Aspen and Cedar for a year now because I see, with absolute clarity, the value they create in the evolution of clinical trials. This technology unlocks potential from independent practices which, because of their small size and relative isolation, previously had been excluded from participation. Importantly, it casts an even wider net, now Texas and eventually even the nation, which is essential in identifying those ‘unicorn’ patients that are so difficult to match as trials become increasingly specific in their inclusion and exclusion criteria. I have patients in my practice who deserve to be involved in these conversations. Aspen and Cedar are able to deliver this opportunity for these women.
To comprehend why this is, I would like to tell you a little bit about myself. As a representation of the typical independent physician, I think that understanding my thoughts, my motivations, and my priority, will give clarity as to why this novel structure will appeal to thousands of other physicians like myself.
As is common with physicians, I was raised in medicine. My grandfather was in the first graduating class at UT Southwestern. He was a general practitioner in the days when that meant everything from home deliveries to appendectomies. I am also fortunate to share a practice with my father, who is still working today at the age of 71. As you can imagine, having a mentor like him during my formative years was truly irreplaceable. Our practice maintains an affiliation with Southwestern, so I have some opportunity to teach medical students, residents, and fellows in a surgical setting, but the involvement is far less robust than a traditional academic position. To this end, I’ve always lamented the loss of mentoring opportunities which I knew would result from going into private practice. Over the past 12 years, I have looked for various ways to fill this void. I spent some time working with a Board preparatory course for medical students offered over the internet. Here I served as a chief editor to develop the OBGYN portion of the curriculum. This eventually led to an expansion of professional opportunities outside of my medical practice to include the development of a women’s health laboratory which currently services 15% of private practitioners in Texas. These experiences,while I recognize them to be incredibly unique and personal to me, reflect, I think, a commonality that many private practice physicians are looking for. Doctors desire community. They want to be linked to the larger practice of medicine. They want to give back both in their clinic as well as to the community at large. I have been consulting with Aspen and Cedar for the previous year because I feel that their product gives physicians exactly these opportunities.
I’d like to build this picture up a little more. To understand this worldview even better, allow me to take you through the arc of a physician’s training and practice.
Consider the position that all physicians enter their chosen profession as idealists. Without ignoring the many benefits that come from a career as a doctor, it is a life one begins with full knowledge of the long hours, physical toil, financial stress, and personal sacrifice that are necessary at least in the early years if not throughout one’s career. One cannot enter into this journey if one is not motivated by the desire to give back and by a belief that this investment will result in an opportunity to improve the world around them. Additionally, every doctor starts their career as a scientist, and no matter how much you may dread the Kreb’s Cycle or feel that it will have little impact on future patient care, you are still obligated to memorize it in college if you want to move on.
Medical school itself then becomes an interesting contrast between classroom and clinical. In the first two years, the polished and unchallengeable truth of the textbook takes hold. Everything is simplified to one right answer on a multiple-choice test. Science seems so crisp and clean. It is in the second half, when clinical rotations are introduced, that the messy inconveniences of individualization and imperfect knowledge are revealed. I wonder if the scientists in this room have their own version of the adage that we quote, “Patients don’t always follow the textbook…”. And yet these years are also essential in re-enforcing that this doesn’t mean that we should just throw those textbooks out of the window. Exemplary medical care builds from the foundation of evidence-based medicine, then individualizes decisions through the lens of a patient’s unique situation and, indeed, her own subjective system of values and priority. This is where great doctors excel over time; the ability to realize when to apply the law of averages as concluded by a clinical trial vs when to step away from the evidence with the knowledge that no study is perfect in its ability to account for every situation. This level of intimacy in analysis can only be reached through a close connection with your patient;a personal connection which is the foundation of transcendent care.
As training moves into residency, the double-blind, placebo-controlled trial becomes a god of truth; cutting through myths and unveiling what was hidden. When in doubt, always follow the evidence. It’s not a bad maxim to hold to when you begin, but extreme incorporation of this leads to an almost cult-like analysis of the decision tree that leaves no room for thought or interpretation. There was ‘the Northwestern way” when I was training in Chicago, and you will be hard pressed to find someone in my hospital who was willing to stray from it. When they did, the residents would often look to each other with raised brow and the certain understanding that this attending was foolish beyond the limits of credulity. This practice of circular affirmation resulting in its codification of beliefs leaves these young physicians with the certainty that their algorithm is the only way. There is an acceptance that evidence has changed over time, but this is countered by the illusion that you are at the end of its evolution. And then after this is cemented in place, training is over, and you get a job.
And private practice is a funny thing. Years of structure, apprenticing, protocols, and supervision vanish on your first day caring for patients in the hospital. School and training are a time for friendships, community, and fraternity. But when you open your practice, it’s like falling into your own mini universe. You’re the boss, directing your team of nurses but without any other doctors working on your team. It’s a conflicting feeling knowing that suddenly no one is looking over your shoulder. This liberation and freedom to practice as you see fit is balanced by fear in knowing that your actions may result in irreparable harm if you don’t have the foresight or intuition to know when to ask for help. If I’m being candid, there is even a moment when you have the realization that you can be as bad of a doctor as you want. You can cut every corner, skip every duty, and prioritize yourself over your patients if only you could have so poor of a moral compass as to allow such behavior. After you get past that realization, the next issue for you to struggle with is the fact that everyone is practicing medicine differently from how you were trained. Gone are the codified rituals that you took for absolute truth. In fact, running patients through those time-tested protocols of your training only seems to get you looks of suspicion from the nurses and whispers about you in the doctors’ lounge. It’s interesting that, even with partners in your own practice, the ability to gain insight into who is a ‘good doctor’ whom you would refer a friend to and who isn’t, is a difficult and strangely opaque task. Almost without exception, you will never sit in an exam room and hear a colleague counsel a patient, you won’t see the decisions that bring them to a recommendation or experience their bedside manner, and outside of your partners, you definitely won’t see anyone operate. In fact, the best insight a physician can get into the competence of his or her colleagues is from the nurses, and anyone can just as easily call Labor & Delivery on a Saturday afternoon and ask the person who answers for a recommendation of an Obstetrician in their hospital.
But you figure your own practice out. You ask for help. You review cases with your partners. You are intensely thoughtful of decisions in these early days when your copious time is balanced only by your empty waiting room. As years go by, volume increases, lessons are learned, and you internalize the sage advice of “be careful what you wish for”. Volume goes up. With repetition, a pattern recognition emerges which allows you to be just as effective while still seeing that many more patients. This isn’t a bad thing. You say the same speech so many times that it comes out instinctively, allowing you to counsel on autopilot about general things while, at the same time, your conscious mind is analyzing the things that make a patient unique. You sense when you need to slow down and when you can speed up. You cram another appointment slot into each new widget of time which your efficiency creates. The varnish fades. The job becomes a job. You love your patients and your sense of purpose, but you now look to family and hobbies to fill your free time instead of reading the latest studies and pontificating on how to refine your practice. There is no small amount of guilt in becoming a worker who is defined by their life as opposed to their job. I’m sure this transition is healthy, but some part of you misses the excitement of the scientific adventure that led to you medicine in the first place.
So then if I miss these experiences so much, why wouldn’t I want to participate in clinical research after reaching this professional plateau? If my day to day work has reached a point of stability and ease, why not involve myself in areas of professional curiosity? Well, let’s think about the current model for community-based research trials. While the structure of positioning a research coordinator internal to a busy clinic works well for some, it clearly doesn’t work for all. Even a cursory statistical glance at the number of independent clinics who don’t participate in clinical trials will be evidence that there are aspects of this relationship which don’t fit the daily operations of most clinics.
First of all, I’m working with strangers. I’ve either reached out to drug development companies or have been introduced through a colleague, but this new relationship is already off to an unsettling start. At this point, I’ve become king of my castle. I’ve been working with my nurses and staff for years. We have grown into a ‘mini-family’ and share the singular focus of serving the patient while maximizing efficiency in the office so that we can all get out of there and back to our ‘real lives’. And now there is an interloper in our office who has a different agenda from ours. Specifically, they are there to mine my patient base and fill studies. To this end, their primary goal is to help their organization, not necessarily to help my patients. To accomplish this, they have engaged me to sell a product to the women who have put their trust in me. But now, with each interaction, I am serving duel masters;one agnostic:designed to be open-ended in allowing patients a wide menu of options to choose from, the other: a narrow funnel intended to push those same women toward a single path of registering for a clinical trial. If this characterization seems overly harsh in principal, consider how it feels when you are working on a trial that is months behind its predicted recruitment. Even the most ethical professionals feel the weighty tug of this latter pathway.
I am also conflicted at this point based on my reasons and rewards. As a generalist, I don’t really have any personal motivation for guiding a patient from one decision to another. Doctors are more successful if they give great care and get more referrals. What that care is doesn’t really matter. Now, I have deliberately entered into a relationship where I am financially rewarded for filling trials with my patients. If a patient is on the fence and I can push her toward participation, I create value for myself. It is hard to understand from the outside how disruptive this paradigm shift can be for a provider. It is a fundamental change from how we have been trained and the ethos which has been imprinted on us. This leads to emotional and moral confusion. Worse for the trial, it may have the counter effect of causing us to steer some patients away from the trial as we are now confused as to a particular patient’s best interests vs our own. We become even more conservative in our counseling and might offer trial participation even less.
Now let me be careful here. It is not that I am opposed to matching appropriate and interested women to clinical trials which are advancing science. Quite the contrary, I view it as one of the obligations of my role as a physician. But accomplishing this goal well takes time and a panoramic lens. If I have a patient base of 5000 women, I don’t want to be sifting through them at a rate of 20 a day. I don’t want luck to determine who walks in the door. And I don’t want to be discussing an endometriosis trial with a woman who has come to see me for testing after her husband’s infidelity. It is this friction of incongruent agendas which causes my discomfort, and the need to prioritize the time that I do have, can lead to resentment against a trial when I’m forced to choose between mourning with a mother who has experienced a loss or discussing trial enrollment in the next room. That time is not a luxury that I have during my typical workday.
This emotional conflict is mirrored in my office workflow as well. The flow and muscle memory that has helped my practice evolve into a low stress and highly efficient machine is now thrown off the rails by the research coordinator pulling on my sleeve trying to focus my attention on her agenda as opposed to ours. The counseling for this side job often throws me behind for a scheduled visit, which has a domino effect on the rest of my day. Now, I can’t stop thinking about my waiting room which is filling and questioning if my selfishness is impacting the respect that I have always placed on my patients’ time. My anxiety grows in step with my irritation with the partner who has carved out precious space from my clinic for her charts and documents, now both emotionally and physically interrupting the zen that I took years to slowly establish. And as to those documents, I did not become a physician because I like paperwork. I chose medicine so I could spend my time with patients and enjoy working with my hands. While I am familiar with the work of a Principal Investigator, I have not been trained in it, nor do I have any particular interest in these responsibilities. The most direct and effective way to make a physician uncomfortable is to put him or her in charge of something in which one doesnt feel competent. I’m a gynecologist, an obstetrician, and a surgeon. Approving patients for investigative medications or interventions? Clearing them from a cardiac or neurologic perspective? I don’t even do that for my surgical patients.I send them for pre-operative appointments with internists. Combine that with stacks of paperwork, legal responsibility, and the uncertainty of outcomes? We have found our way to a quick “No, thank you”. Many practitioners who have gone down this road find within a matter of time that the juice is not worth the squeeze. Yes, there may be a fractional increase in annual income for the practice, but there is also a value that you ascribe to ease and convenience. The income most clinics accrue from trials does not compensate for this disruption. To those organizations and clinics who have found a way to do this well, I give a respectful bow of congratulations. But for the dramatically larger pool of us who haven’t been able to make this work, there must be another solution.
So then why am I so excited about this venture with Aspen and Cedar? Quite simply, this technology and this structure allow me to focus my practice on the specific values that I bring to clinical research while outsourcing those that I am not interested in to the experts. And essentially, all of this work is exported out from my clinical day so that my participation is compartmentalized. There is no negative impact on my clinical staff, my time with my patients, or my priority in providing them uncompromised care. Quite simply, my value to a research organization is in access to my patient base as well as my relationship with those patients translating to an ability to encourage appropriate women to participate in appropriate studies. It is certainly not in my skills as a Principal Investigator,a participation which often results in frustration for both my office as well as for the sponsor.
In this model, I receive from Aspen Insights a curated and numerically ranked list of patients sourced from my EMR who qualify for each trial as it opens. I can see my entire roster of active patients at once, and I am able to review this list after office hours, to determine which of these matches I feel is appropriate and would be receptive to recruitment. Importantly, I am not limited by chance on which patients come to my office a certain day or month or year, so I feel like I am selecting the very best options and not pressuring myself to force women into participation who don’t really fit the bill. I am able to contact those patients on my own time using lines of communication of my choosing, so I can carefully counsel her on the personal value of her participation. If the patient does indeed have an interest, I am able to refer her to a convenient off-site location for the mechanics of the trail, while endorsing Cedar Research as a trusted team of the highest caliber conducting their work in the appropriate setting. No more relying on practicing physicians to stand in the role of Principal Investigator, which we aren’t skilled at, and our clinics are not prepared for. On a professional level, this provides me with engagement in the scientific community that I was previously disconnected from. It provides opportunities for my patients that they otherwise would have had to go to other practices to receive, and it brings value to my office through an affiliation with academic medicine, branding my establishment as one which emphasizes research as part of my care. In short, it rips all of the good out of the current paradigm while leaving behind all of the inconvenient and inappropriate.
My feelings on this are not unique. There are many physicians like me. Indeed, in a community of over 500 OB/GYNs in Texas with which we currently have connectivity, I have already spoken with a number of thought leaders for practices who are looking for just this type of opportunity. Over 90% of these physicians are not participating in research and have no interest in the current model. Despite this, every single one of the doctors I have introduced to Aspen and Cedar over the past few months has expressed a desire to participate in our initial trials. They are attracted to it because of its ease. They are attracted to it, because it respects the physician’s time and priority on the patient in a way which has never before been envisioned. I am excited for this opportunity to introduce you to a sea-change in how clinical research will be conducted in independent community offices in the future. A change which brings engagement to physicians, value to patients, and success to essential research organizations. A change that allows so many more of us to work together to advance medicine and improve healthcare.