The Laszlo Letter

Sharing Clinical Data through Application Integration

Notes from the 23^rd DIA CDM conference

While I’m not enamored of attending conference sessions that start at 8:30 in the morning, I was glad that I made it to the Tuesday morning session on “Accessing Clinical Trial Management Information from eClinical Systems and Capabilities” chaired by Paul Bleicher of Phase Forward.

Before I jump into the details, I want to warn you that the words “clinical trial management information” in the title of the session can be misleading. This is because of a key learning that I took away from this session. In short, when we begin to effectively extract and use data and metadata from all of the transactional systems at our disposal, they become (in aggregate) a comprehensive clinical trial management environment. In other words, we no longer need a CTMS because we have achieved a CTME(nvironment).

DIA Euromeeting: Impressions and Recommendations

I’m writing this on the plane to New York from Barcelona having just attended the 2008 DIA Euromeeting. As a veteran of many DIA annual meetings in the USA, I must admit that this year’s Euromeeting was like a breath of fresh air. A key reason for this may be the calculated risk that the meeting planners took by redesigning the program around themes and sessions.

Suggestion: Click here to see a phenomenal set of Barcelona photos!

Virtual Software Testing with StackSafe

It's not too often that I run into something innovative that leads to the thought: "Why didn't I think of that?"

This is exactly what happened the other day on reading the following passage in the February 4th issue of Information Week:

"Two-year-old StackSafe showed how its first product, Test Center, captures snapshots of the IT production environment, stores them, and then assembles virtualized production environments in which to test software changes."

I then found a somewhat longer article on this product here. In that article you can also learn about a competing product called StageManager from VMWare.

What's intriguing about this product is the possibility of replacing the physical hardware and software instance that we currently use to validate software. Instead of continuously maintaining a development, test and production environment, you keep the development and production environments and create virtual test environments as necessary.

Note: If you are new to the concept of virtualization, read this prior post.

By dropping out the physical test environment, you save both hardware and maintenance costs. More importantly, creating a virtual test environment will assure that the tests you run correctly represent the impact of changes on the "real" production environment. Let's face it, the production environment is never exactly the same as the current physical test environment.

A move to such an environment has regulatory implications that must be addressed. First, the validation program itself will need to change and include the validation of the virtual test environment from creation to use to deletion. In other words, you will need to prove that using a product like StackSafe Test Center for validation can be done reliably and consistently. Second, you will need to have some assurance from regulators (e.g. FDA or EMEA) that using virtualization in this manner is acceptable to them. It never hurts to ask!

The unacceptable alternative would simply be to ignore this method and assume that the regulators wouldn't approve.

FDA Information Technology Plan (Draft)

Your chance to comment!

If you or your company is in any way affected by the way the FDA handles your pre- or post-approval activities, then you should be interested in the information technology plan that it plans to use over the next five years.

The draft plan was released on December 27th, 2007. Comments are due to the FDA by Friday, February 22, 2008. The Docket number for this plan is 2007D-0481.

Having read this 37 page document, I can tell you that it will be no easy task to either understand what they want or to collect your thoughts. Never the less, submitting your comments should be a priority. With this post, it is my intention to make it a bit easier to get through the comment process.

Read on...

2008: IT budgets to fall?

If the pundits are right, IT budgets will be smaller next year. Or, to put it more correctly, the percent increase for 2008 over 2007 will be less than the percent increase for 2007 over 2006. Are you still with me?

As an example, take the recent article by John Soat of Information Week, who cites two separate surveys involving CIOs. Both predict smaller budget increases for 2008. Mind you, this is across all industries and it's not clear what will happen in the Biopharma sector.

We can guess, however, that based on the somewhat dismal performance of most pharma and some biotech companies, CEOs will be looking for savings wherever they can be found. And that includes IT.

From my perspective, this is quite unfortunate since I am convinced that our industry has squandered countless opportunities to leverage information technologies to improve both day-to-day operations and improve the R&D pipeline. If you want examples, I'll give you several:

• document management and electronic publishing
• data management and exploration
• electronic data collection (EDC)
• clinical trial management
• master data management

Now, you may be saying: "Is this guy nuts? These are the areas where we have made the most progress!"

And no, I'm not nuts. These are great examples where lots of time and money have been wasted or investments underperformed. Despite glowing reports at DIA meetings and other venues, the reality is that we still don't know how to properly leverage IT.

I'll offer just a few reasons why our IT dollars/euros don't get us the returns we need:

1. Lack of resolve and leadership to change course;
2. Continued disconnect between the business community and the IT organization;
3. Missing or half-baked strategy for improving productivity;
4. Cowardly management disguised as management by consensus;
5. Focus on regulatory compliance rather than operating efficiency;
6. Failure to create a learning and innovative organization;
7. Over-reliance on selecting technology rather than setting strategy that drives technology.

So, it's possible that we don't actually need to increase the IT budget. Maybe it would be enough to just stop wasting it.

Bedside Portable Computer

Motion Computing has announced the availability of their Motion C5 Mobile Clinical Assistant (MCA) tablet computer. This flash demo gives a good overview of the device.

The device was created in collaboration with Intel Digital Health Group. While currently intended for hopital use, the tablet could be used for other purposes such as EDC.

It should be noted that the device is primarily a hardware solution and does not come with healthcare application software. A good example of the way the device can be adapted for bedside use is described in this field study by Intel. In this case, the tablet was integrated with the Eclipsys Sunrise Clinical Manager platform.

The unit uses the Intel Centrino processor, runs on either MS Vista or XP and includes a bar code reader, RFID reader and digital camera. It also supports wireless and bluetooth connectivity.

Biopharm IT Leaders - The Infoweek 500

The 19th Annual Information Week 500 list has been published.

Here, we will only concentrate on the Biotechnology and Pharmaceutical companies that made the list.

As the publication states, "to be ranked, companies with at least $500 million in annual revenue are asked to complete a qualifying application that examines business technology strategies. The application contains a quantitative section on technology initiatives and priorities, and a qualitative section of essay questions. The responses to these two sections are evaluated, weighted, and combined into a total score to rank the companies."

The following Biotech and Pharma companies made the list:

• BD Biosciences
• Beckman Coulter
• Eli Lilly
• Genzyme
• GSK
• Merck
• Pfizer
• Roche Diagnostics
• Schering Plough
• Solvay
• Thermo Fisher Scientific
• Wyeth

Of these, only three made it into the top 250 list. These are:

• Eli Lilly - #50
• Wyeth - #59
• Roche Diagnostics - #231

Read on to learn a bit more...

Big Brother has arrived

While I can see lots of great legitimate uses for a product of this sort, it's focus on surveillance reminds me of the adage "throwing the baby out with the bath water." In this case, we potentially make a lot of people suffer from the unwanted actions of a few. Strictly my opinion, of course. What do you think?

If you are interested to know what Spector 360 is all about, read on...

Bridging Pharma and IT

"The beatings will continue until morale improves!"

I was reminded of this quote on receiving a brochure from Cambridge Healthtech Institute (CHI) promoting their upcoming "3rd Annual Bridging Pharma and IT" conference. For those who are interested, the meeting will be held in Boston from September 30 to October 2, 2007.

The quote popped into my head after a momentary feeling of dismay that after 20-30 years of discussion this "bridge" has still to be completed. Apparently there has been much talk and little action. Or perhaps, more correctly, very little effective action.

And so, we continue to "beat" the issue in hopes of positive progress. I'd like to suggest, however, that a different approach is needed. Perhaps one that does not require bridges at all.

But first, let me give you my take on this conference.

Healthcare Standards and Healthcare IT

The (re)use of patient data in the form of the electronic medical/health record (EMR/EHR) will be discussed in three separate sessions at the annual DIA meeting and is an emerging topic within our industry.

Two key uses within clinical research are 1. patient recruitment and 2. encounter based clinical data collection. There is also great potential for using EMR/EHR data for signal detection in pharmacovigilance. These examples only begin to scratch the surface of potential uses.

From my point of view, our industry is still in the learning phase when it comes to the potential impact of EHR/EMR on the way we conduct R&D or deliver better care. So, what better way to learn than read what our colleagues in the healthcare provider world have written about EMR/EHR and related issues.

To that end, I'd like to recommend that you look at a multi-part essay written by Steve Beller Ph.D. on the Trusted.MD web site. Since that site makes getting to all the parts a bit mysterious, I am giving you the link to each part below:

• Part 1 - Better care delivery through knowledge reuse
• Part 2 - Types of standards
• Part 3 - Issues related to healthcare standards
• Part 4 - HL7 messaging
• Part 5 - Problems with healthcare standards
• Part 6 - Use of innovative technologies