The Laszlo Letter

Electronic Health Records (EHR) coverage at HIMSS

The annual meeting of the Healthcare Information and Management Systems Society (HIMSS) took place last week in Chicago. While there are many publications out there covering this meeting, ChannelWeb had an especially good series of articles on it.

Those of you who are not yet familiar with ChannelWeb, it is a web site focusing on companies that sell computer and communication based solutions (i.e. hardware and software.) In other words, the sellers ARE the channel.

As you will see from these articles, the most popular topic at HIMSS was the Obama stimulus package and its implications for health care. As you can imagine, vendors had a Pavlovian reaction about the potential to make a lot of money.

How well the money will be spent remains an open item. Once thing is certain. A lot of it will be wasted.

Read on...

HIMSS: Moving From Stimulus Hope To Real Health-Care IT Projects
ChannelWeb , April 10, 2009
At HIMSS, VARs, CIOs and vendors look past the initial round of stimulus excitement to gauge what's coming next.

20 Scenes From HIMSS 2009
ChannelWeb , April 09, 2009
The annual HIMSS conference brought more than 27,000 attendees to McCormick Place in Chicago, to hear from each other and from the likes of Dennis Quaid and Alan Greenspan as they place their bets on the future of health care IT. A strong pulse? You bet--and Channelweb was there to check it.

HIMSS: Greenspan Says Economy 'Will Turn, But Not Yet'
ChannelWeb , April 08, 2009
At HIMSS, Alan Greenspan addresses technology's role in health care and the broader economy.

HIMSS: Dell, Perot Systems Unleash Health Care IT Salvo
ChannelWeb , April 06, 2009
Dell announces partnerships with Perot Systems and others and virtualization and social networking solutions for health care

HIMSS: Dennis Quaid Calls On Health-Care Modernization To Eliminate Errors
ChannelWeb , April 05, 2009
Actor Dennis Quaid said at HIMSS keynote that health-care IT technology is the only way to reduce medical errors.

HIMSS Preview: Health Care Tech Revs Up As Stimulus Begins
ChannelWeb , April 03, 2009
Electronic medical records and health care IT funding from the federal stimulus package are on everyone's minds as HIMSS gets under way in Chicago.

Health Care IT: 25 Solutions To Check Out At HIMSS
ChannelWeb , April 02, 2009
A sampling of products and solutions to see at the 2009 HIMSS Conference in Chicago.

Software for Clinical Development - 2009 Edition

Many of you have written to me over the past year that the MS Excel spreadsheet I created last year that listed software for clinical development was very useful.

Some people also wrote in that the list was by no means complete. Of course, they also told me which software packages were missing.

So, without further ado, here is an up-to-date list for 2009. Of course, I expect that several readers will again let me know that it's still not complete!

Download ClinDevSoftwareVendors-2009

Obama, Healthcare IT and the FDA

Today is day 2 of Obama's presidency.

While I do not expect him to even think about the FDA just yet, his inauguration led me to speculate about the possible changes that may come about for Healthcare IT in general and the FDA in particular. Somewhat coincidentally, these thoughts came out on inauguration day in the now weekly magazine Pharmaceutical Executive Europe. If you don't yet subscribe to this wholly electronic publication, consider doing so.

Click here to read the article which begins on Page 8. Your own thoughts on these topics are welcome.

Obama's Healthcare Team

Next week the USA gets a new President!

Anyone who is interested in what Obama will do with Healthcare should be interested in the colorful cast of characters that he has (and will) assembled to tackle this monster. One of them is Peter Orszag who will now be his budget director.

An Economist by training, Mr. Orszag already knows a thing or two about healthcare. He's got the facts on the spending front and has a few ideas about putting healthcare on a diet.

If you want to know more, there is plenty of that on the Internet. Here is one pretty good review (The Number Cruncher in Chief) about Mr. Orszag. Skim it first and then decide what parts you want to read.

Quotations from FDA CDER Head Janet Woodcock

Notes from the 23^rd DIA CDM conference

In the next few posts, it is my intention to share with you some of the information presented at the 23^rd DIA Clinical Data Management (CDM) conference. It is also my intention to give you some of my own thoughts about what I saw and heard.

The title of the conference was “Data Management in Transition: Putting the “e” in Data Management.” I am happy to report that the conference organizers did a great job keeping the majority of speakers focused on this topic. So, kudos are in order for Sue Dubman (Theravance), Kristin Neff (Boston Scientific), Paul Bleicher (Phase Forward), Shahla Farr (FDA), Rebecca Kush (CDISC), Denise DeRenzo Lacey (Waife & Associates), Johann Prove (Bayer Schering Pharma), Don Rosen (Rosen Consulting) and Steve Wilson (FDA.)

I could not think of a better approach to get things rolling than to simply convey several quotations from the talk given by the conference keynote speaker, Janet Woodcock MD, of FDA. As you may know, Dr. Woodcock was recently put in charge of CDER and she wasted no time telling us what she thought her division, and indeed all of FDA, should be doing.

These quotes nicely reinforce the tone of the CDM conference, one that was palpable if not always directly stated, namely that The time for change has arrived.

While I was initially tempted to put these quotes in context, I resisted that urge since they are as applicable to what we do in general as to the specific issues being discussed by Dr. Woodcock.

So, mull these over at your leisure and stay tuned for more about the meeting in future posts.

Quotations from Janet Woodcock

“current methods are not sustainable”

[there is] “almost a crisis in the United States to get clinical trials done”

“there is too much data being collected”

[we] “need to link EHR to clinical trials”

“we need to get out of the way we are doing things now”

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!

Reminder: DIA eClinical Meeting - March 16-18, 2008

It's not too late to sign up for the upcoming DIA eClinical meeting that will be held in Washington DC from March 16 to 18, 2008. To see or download the program, click here.

The title of the meeting is "Data Management in Transition: Putting the "e" in Data Management." There will be 63 presentations spread among four tracks:

1. Clinical Data Management - Focusing on the Data
2. CDM/eClinical - Management Best Practices
3. Data Management in Transition - From Keepers of Clean Data to Stewards of the Clinical Data Pathway
4. eClinical Technology Trends and Innovations

The topics to be presented/discussed are summarized on this pie chart. For a larger view in a separate window, hold the Ctrl key and click on the chart.

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Yours truly will be the chair of a panel discussion on "eClinical Futures," a session that will focus on process improvements and emerging information technologies that have the potential to alter the way we currently conduct clinical development. This session will have 5 speakers and will devote significant time to group discussion and audience participation. It is scheduled on Monday, from 1:30 to 3:00 p.m.

Having reviewed the program, here are the topics that I would personally find of interest:

Monday 1:30 p.m. - Track 1 - The FDA Revitalization Act, Drug Safety and Data Management: Great Expectations or Bleak House?

Monday 1:30 p.m. - Track 4 - An Honest Look at the eClinical Process: How Biotech Can Learn from Best Practices Outside the Industry

Monday 3:30 p.m. - Track 2 - Tech(cli)nical Project Managers and Their Role in eCDM

Monday 3:30 p.m. - Track 4 - Standard Representation of Trial Design and Data Management

Tuesday 8:30 a.m. - Track 2 - To Outsource or Not to Outsource? What is the Future of Clinical Data Management?

Tuesday 8:30 a.m. - Track 3 - Redefining Data Management’s Role in EDC

Tuesday 10:30 a.m. - Track 2 - The Impact of the Merger of Merck and Serono on the DM Staff

Tuesday 10:30 a.m. - Track 3 - Statistical Computing Environments: Collaboration through Metadata, People, Process, and Software

Tuesday 1:30 p.m. - Track 2 - Business/Research Value of a Shared Collaboration Platform

Tuesday 1:30 p.m. - Track 3 - A Complex Protocol Design to Accelerate Clinical Trials: How to Implement Multiple Database Lock in an Electronic Data Capture System

Tuesday 3:30 p.m. - Track 2 - CDM without Traditional Clinical Data Management Systems

Tuesday 3:30 p.m. - Track 4 - Connecting Two Worlds: Electronic Health Record Systems Clinical Research

Of course, it makes sense for you to review the entire program to determine which topics would be of the greatest interest to you.

Shire: Clinical Trial Results Website

Shire Plc. has released its consumer-focused clinical trial results web site. You can see it by clicking here.

The site is devoted to completed and discontinued clinical trials that can also be found on the clinicaltrials.gov  or clinicalstudyresults.org web sites. No information on future or ongoing trials are included.

My initial reaction to the site is very favorable. The design is clean, uncluttered and to the point, just what's needed by the average consumer.

Since this is Shire's first attempt at such a site, a few suggestions are in order:

1. The search screen has four pull-down list boxes for Drug Name, Generic Name, Threapeutic Area and Disease State. Since it's possible to select an item from each of these lists, it is very likely that consumers will create combinations that don't make any sense. In such cases, the system will correctly return the message: "0 records found" and leave the consumer confused, dissatisfied or both. So, either make the pull-down lists context sensitive or allow them to search on one list at a time. A small instruction box next to the search function would also help. And, it would also be nice to have a "reset" button in case a consumer wishes to revise their search selections.

2. Clicking the "View Details" link on a search hit opens a study details screen. The most important part of this screen shows the study summary and gives a link to a PDF file giving a detailed exposition of the study. Unfortunately, the study summary simply repeats what the trial was about without giving any of the efficacy or safety results. For that, you have to open the PDF file and search within that for the results section. In addition, the results (once found) are in typical scientific jargon. So, two suggestions are in order: a. provide a plain-language study summary on the Details screen and b. provide a longer plain-language abstract of the whole study via a second link also on the Details screen. (N.B. - Yes, there are legal implications here, but not any that legal and regulatory counsel can't deal with.)

3. The Main Menu also provides a link to a Glossary of relevant terms. The Glossary itself is very nicely done. To make it more effective, it is suggested that a link from each trial Detail screen open a window showing a subset of the glossary relevant to the therapeutic area to which the drug belongs. This would be easy to do by simply adding another field to the Glossary database signifying the therapeutic area.

On the whole, congratulations to Shire for providing a simple but effective tool to consumers.

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...

FCG: ECM with FirstPoint

Jennifer Wemstrom of FCG introduced the FirstPoint Life Sciences ECM solution at the Trends 2007 conference held on November 8, 2007 in Princeton, New Jersey.

Note: This is one of many posts related to the Trends 2007 conference. Each post about this conference uses the same illustration shown to the left.

FCG, already well known for its FirstDoc solution suite, has been working closely with Microsoft to plan, design and implement this new Sharepoint (SP) based solution.

Jennifer was quick to point out that FCG will continue to support the FirstDoc platform and that the FirstPoint solution was not simply an attempt to create an FirstDoc-equivalent solution on SP.