Thursday, September 21, 2006

The holes in the quest to enable the electronic clinical trial ...

... may be in the heads of the pharmaceutical industry's information technology leadership.

Readers of Healthcare Renewal are familiar with stories about industry mismanagement, conflicts of interest, corrupt practices, and other ills. I try to add the angle of technologic backwardness and blindness to state-of-the-art thinking about clinical information technology.

Recently posted to a number of medical informatics-related membership lists was the announcement of this Drug Information Association-sponsored conference:

"The Quest to Enable the Electronic Clinical Trial: Finding Clarity in a Confusing World" (300kb pdf)

I find the conference brochure quite interesting. There are numerous talks on medical informatics-related subjects, including "Medical Informatics Opportunities to Improve the Benefit-Risk Assessment of Drugs", "EMR's, PHR's and Electronic Clinical Trials: Pathways to Convergence", and even a tutorial "Introduction to Biomedical and Health Informatics" by reputable industry and academic speakers.

It is good to see more publicity about Medical Informatics in a pharmaceutical domain. As I've dicsussed in previous posts including here and here, the field has been nearly invisible to pharma, and it has been pharma's loss.

However, also of interest regarding this conference is a critical area studied in medical informatics that is entirely omitted. Once again, it's that "messy" area of organizational and sociological issues that impede clinical IT progress and cause healthcare IT difficulties and failure , including the current chaos in the Connecting for Health national programme for Health IT in the United Kingdom:

Leaked papers reveal NHS computer problems

A multi-million pound national project to upgrade computer systems across the NHS has been so dogged by problems that hospitals would have been better off if it had never been started, according to a confidential document apparently written by one of the scheme's most senior former executives.

The anonymous document, obtained by The Observer, appears to have been sent from the computer of David Kwo, who was in charge of implementing the Connecting for Health system in London until last year.

The analysis warns that "the NHS would most likely have been better off without the national programme, in terms of what is likely to be delivered and when.

In my experience (I was formerly a group director in the Research Information Systems division of a large pharma), pharma is blind to these issues. Worse, they don't know what they don't know. I can envision similar chaos in the race for the eClinical trial, chaos compounded by the simulataneous challenge for healthcare providers in implementing EMR's and other clinical IT for ordinary day-to-day patient care.

It's also an area that in my experience IT leaders in the pharmaceutical industry won't touch and seem to believe doesn't exist, or is of no importance to the "process-driven" world of pharma. Such debacles as the failed $100 million CRISP system at Merck were the result:

... Merck saw the potential to use information technology to compress the clinical trials process a long time ago, and has had supporting information systems in place for 30 years or more, although it hasn't always been a smooth process.

In the 1990s, Merck struggled to erect a modernized clinical data system known as CRISP (Clinical and Regulatory Information Strategic Program), a project that current and former information systems workers came to regard as a $100 million fiasco.

"This project ran into a lot of problems," says one former manager who was involved near the beginning of the CRISP project. He asked that his name not be used ... The problems started when Merck decided to create a graphical user interface to CRISP, allowing clinical researchers to do their own data entry rather than having Merck personnel transcribe the results from paper forms.

Merck significantly underestimated the challenge, according to a former Merck executive who was involved in the early phases. Merck's scientists were impressed by the ease of use of the Apple Macintosh computers they were using at the time. They thought creating a graphical data collection tool ought to be an easy task for Merck's programmers.

The task of creating this software led the programmers into unfamiliar territory. Not only did they have to learn new programming techniques, but they were continually frustrated in their effort to build a single system that would work for all trials. The real problem was that the data to be collected varies significantly with the nature of the medicine being tested and the malady it addresses.

The "territory" was unfamiliar only to those in IT management who are not engaged in its study. It is not hard to foresee similar debacles for many companies in the future.

The pharmaceutical eClinical trials conference discusses pharma/provider interaction and implies that pharma will become "an embedded part of healthcare's transformation through health IT." The conference concludes with a panel discussion on the somewhat ironic question "Where are the holes in the quest to enable the electronic clinical trial?"

The organizational and sociological issues that impede healthcare IT progress have strong analogs in the pharma industry. I observed them with interest as a member of a research IT division at Merck, after a period as Director of Informatics implementing EMR at a large healthcare system. I believe that collaborations between pharma and provider organizations that don't take these issues into account in any joint work in eClinical trials may find these sociotechnical issues worse than simply additive.

However, pharma is at this point blind to these particular "holes." I predict there will be hundreds of millions of dollars wasted per pharma (money that drug purchasers provide and shareholders will lose) in efforts to automate clinical trials that do not take the sociotechnical factors into account.

I also think some answers to the question "Where are the holes in the quest to enable the electronic clinical trial?" will be found in an upcoming Nov. 2006 American Medical Informatics Association Annual Conference workshop on healthcare IT failure entitled "Avoiding The F-Word: IT Project Morbidity, Mortality, and Immortality", the first of its kind:


Recent studies of health care computer applications and the reported failures of well-known systems surprised the medical informatics community, leading to questions of how to increase the chances of IT systems success and the reduction of errors.

Similar problems plague a variety of different systems, whether for institutions as a whole, for ancillary services, or for consumer health, and have done so for many years. Despite an accumulation of best practices research that has identified a series of success factors, some 40% of information technology developments in a variety of sectors are either abandoned or fail, while fewer than 40% of large systems purchased from vendors meet their goals. According to the recent CHAOS Report by The Standish Group, which surveyed failures of IT in general (not just in health care), only 34% of IT projects were considered truly successful. Similar numbers have been estimated for health care, and the number has unfortunately remained approximately the same for at least the last 25 years. While there have been some published reports of failures, removals, sabotage of systems, or how failures became successes or were otherwise redefined, there has been too little opportunity to learn from studies in which technology interventions resulted in null, negative, or disappointing results.

The purpose of this session is to examine why this happens and what might be done to improve the situation, and to collaboratively develop a series of frameworks for various types of systems and healthcare settings to aid in implementation and evaluation. The session builds on a lively exchange by numerous members of a number of AMIA Working Groups concerning success and failure in medical informatics.

The session will be devoted to better defining or characterizing "success" and "failure." From there, participants will break out into smaller groups to continue the discussion, develop a set of important issues, action items, and recommendations.

I will be representing the AMIA Clinical Information Systems Working Group at this workshop. The workshop idea was largely the result of an energetic reponse and flurry of emails in the Medical Informatics clinical information systems mailing list that resulted from my research assistant's message seeking additional cases of healthcare IT difficulty for the web site on the subject I created in 1998. This website "Sociotechnologic issues in clinical computing: Common examples of healthcare IT failure" remains nearly unique to this day. In past years, similar requests produced little interest. I hypothesize that in the intervening years, more medical informatics personnel have become familiar with the issue of health IT discord and failure, or have experienced the issues personally. I will be presenting a poster on the website at the AMIA annual conference as well:

Access Patterns to a Website on Healthcare IT Failure
Organizational and human factors issues associated with healthcare IT have led to project difficulties and failures. Detailed case accounts might improve knowledge sharing between healthcare organizations on lessons learned and best implementation practices. We conducted a study of access patterns to a website created by our first author that explicitly addresses the issue of health IT failure via highly detailed case accounts in an ‘anonymized’ format. We found that our website is one of few relevant sites that is retrieved via major search engine queries on “healthcare IT failure” or related concepts, and we hypothesize that “hits” on our website may reflect a significant portion of the demand for information on this issue. We then studied the demographics and queries used by viewers of our website via a public website-tracking utility (no personally-identifiable information was obtained). We found that demand for information on healthcare IT difficulty and failure via the Web is ongoing by searchers of a variety of demographics, and we believe the demand is largely unmet. The medical informatics community can contribute to filling this gap.

A talk "Medical Informatics Perspectives on Pharma eClinical: Leveraging EMR Expertise" presented by me at a CBI-sponsored eClinical meeting was an attempt to start to bridge this knowledge gap in pharma. It seemed of interest to the pharma audience. The "Gartner Predicts" in that presentation should also be of interest.

As an end note, it was ironic that expertise in Medical Informatics and healthcare IT was seen as unneeded by the former VP of Research Information Systems at Merck Research Labs, who had me laid off as part of a 2003 restructuring and later eliminated one of the two science research libraries I ran at MRL. I had been the only formally-trained Medical Informatics specialist at this company. In 2005, that VP's contract was not renewed. That person, of an IT background but lacking a biomedical and scientific background, now works for a company "dedicated to delivering dynamic interactive realism to the ever demanding complexity of next generation computer games."

-- SS

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