Robert M. Califf, MD

10 big pharma companies announced the initiation of a new non-profit, TransCelerate BioPharma, which is a joint venture intended to improve the efficiency of clinical trials.  This is serious business. Garry Neill has left a major job at J&J to make this work and the plans are to enact some major reforms in industry conduct of clinical trials.  This is great news for the Clinical Trials Transformation Initiative (CTTI), our public-private partnership with FDA, and dozens of other entities.  We’ve been studying the clinical trials enterprise and producing evidence to inform policy makers–it all points to the clear message that we could get much more reliable answers at a much lower cost if we change the system to rid ourselves of useless processes that add no value but cost a huge amount of money.  Then the available R&D budgets could be used to develop a lot more treatments and to develop more reliable evidence about the true balance of risk and benefit.

Stay tuned for major announcements next week from NIH and other government agencies about similar efforts on the government side!

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I survived 8 hours of training and even passed the test at the end.  It had very impressive organization and a highly disciplined systematic approach to the orientation. It is a lot of pointing and clicking and it seems clear that busy clinicians will do well with the system, but there are many complex and non-intuitive shortcuts that will make it more difficult for “part-time” clinicians like me.

Despite the many positive aspects of Maestro Care, I admit to slight remorse about the end of the “glory” days of medicine.  The red light, blue light, green light system enables every step of the clinician to be traced:  process engineering is here to stay!  The “role” of the doctor as a “provider” is a cog in a system.  If handled well, systems analysis and improvement will almost surely lead to better outcomes for populations and patients.  I just have to admit that its a little disconcerting to be demystified.  It was very gratifying to be “the doctor” instead of the “provider role”!

The second issue that we’ll need to work on with the may other EPIC sites is how to pay attention to the patient while so much energy is spent minding the keyboard.  This will be a new skill for the doctor, especially for my generation.  The younger generation will probably do well with this.

Third issue: research wasn’t mentioned.  Given the amazing resilience of our faculty to persist in doing research, it was hard for me to sit there and not point out that we have a spectacular plan to deal with this, started by Asif Ahmad before most people were thinking about it, and hyper-accelerated by Jeff Ferranti, Art Glasgow, Howard Shang and many others in DHTS, now including Iain Sanderson who brings great vision to this.  Finally, we will have codified data for simple items like BP, heart rate, weight, cigarette smoking.  It still astounds lay people when they hear that we don’t have this already in a systematic fashion. The Enterprise Data Warehouse at Duke will be a phenomenal resource for researchers as well as clinical quality leaders, administrators and health system planners.

If we use the data we generate wisely, all of our patients will benefit as individuals.

All in all, a price well worth it, and a big shift in the practice of medicine.  But its not as if anyone is satisfied that we’ve figured out exactly how to implement system wide electronic records in the optimal way.  To really make it worth it, all of us should constantly question the approaches being advocated and provide the feedback needed so that in the end we produce higher quality, more efficient care (lower cost per successful clinical care) and great research that will enable us to more often have confidence that our practices are correct.

Tomorrow I get to start my 8 hours of EPIC Training. At this stage of my career, being able to practice medicine is an amazing privilege, as my research and administrative duties are all consuming.  My many years of intense coronary care and clinic have left me with an unbreakable bond to the awesome responsibility of seeing patients and helping them solve their problems.

EPIC now plays a legendary role in American medicine.  It has become the dominant academic system EHR.  According to some, it is a Godsend–the Microsoft Word of medicine, and to others it is an evil embodiment of the captivation of caring medical attention by the mouse and keyboard.  The potential of EPIC to provide a basis for medical practice based on evidence is profound, but its dominant position has clear dangers.  What if EPIC is bought by a different business?  Will it try to dominate the data warehouse business?   What if prices continue to escalate, but the huge sunk costs make it impossible for systems to extricate themselves–this has been termed “kudzu” by other software businesses.

Some informatics experts and techies are claiming that EPIC is too clunky and won’t adapt to a rapidly approaching world of apps on personal devices.

I have no answers to these questions, but am hopeful that EPIC will be part of the solution in a world that could advance considerably with high quality data that could unlock the secrets of biology and response to treatment.  I’m impressed with the plan for Maestro Care at Duke and hope we can implement the kind of system we used to dream about with Gene and Bill Stead, Ed Hammond, Bob Rosati and David Pryor in the early 1980′s!

We’ll see if I’m still standing at 10pm tomorrow when I finish my training.

We had a great visit to Stanford, spending time with Bob Harrington, Rhonda Larsen and many other friends.  It is an amazing campus with even more amazing weather this time of year.  Bob has his work cut out with an ambitious agenda to build translational medicine, population healt, and clinical care.  The resources are substantial.  The visit confirmed the opportunity to take advantage of the loss of 2 great friends and collaborators by strengthening the depth of the research and education team.

Along the way, I stopped at the EXSCEL Trial rejuvenation.  Despite the many trials I’ve done, it’s still a thrill to think about a trial in mid-course.  In this case, we have a potent drug that lowers blood sugar, reduces weight and waist size, and lowers blood pressure and LDL while raising HDL.  The only negative biomarker is a small increase in heart rate.  The trial is underway and in a crucial phase; Amilyn was bought by BMS and Astra Zeneca.  This will cause important changes in the trial, but it’s fair to say that the basic design will remain and, given the enthusiasm of the study coordinators, we will get the answer!

Matt Rowe did a great job of presenting the results of the TRILOGY Trial–a very complicated result.  Despite a superior ability to reliably inhibit platelet aggregation, prasugrel was not superior to clopidogrel in preventing CV events in an ACS population in whom clinicians had decided to proceed with medical treatment alone in preference to coronary revascularization. However, the event curves show separation after 12 months of followup, and counting multiple events per patient, there does appear to be a modest treatment effect.  It will be interesting to see how the clinical world digest these data.

We should experience a very interesting meeting.  Of particular fascination will be the TRILOGY Trial, directly comparing prasugrel and clopidogrel in patients with ACS treated medically.  Magnus Ohman and Matt Roe have led the trial and it will shed important light on  whether clinicians can be comfortable using the generic drug (clopidogrel) or a more expensive drug that is more predictable and effective in inhibiting platelet function.

In addition, we’ll have some intense discussions about the choice of oral anticoagulants in patients with atrial fibrillation: the more expensive new agents or the old standby–warfarin.

Other big news is the approval to go to the next step for Duke-Kunshan University.  I remain convinced that we need collaboration between US and China.