The Laszlo Letter

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.

IT Sessions at DIA 2007

We are now exactly one week away from DIA 2007.

What follows is a selective and somewhat biased list of IT topics that will be given at the annual meeting. Somewhat biased since it is focused on topics of greatest interest to me. Another way to look at it is that I am less interested in topics that have gotten a lot of coverage over the past 3 years and more so in those that focus on emerging issues/opportunities.

As you will see, some of the sessions fall in the same time slot. I was hoping that the DIA could at least have found a way to put sessions on the same topic in different time slot. Maybe next time.

IT Topics at DIA 2007

The DIA 2007 Annual Meeting is only a month away.

Did you know that there will be 80 talks related to information technology at DIA 2007?

Even if you did, it would take a bit of work to figure out which ones you want to attend. So, I'm going to make that a lot easier for you right here.

Just scroll through the following list. It's sorted by topic. When you have identified a topic of interest, go to the DIA web site and search the on-line program to find the day and time it is being presented.

By the way, don't forget to come to my own session on Thursday at 8:30 a.m. The topic is "The future of information technology in clinical development and R&D."

And here is a nice chart to show you how the topics break out. Hold down the <Ctrl> key and click on the image to see a bigger version.

FDA IT Goals and PDUFA IV

The 20th Annual DIA Conference for Electronic Document Management was the forum for an all day regulatory update kicked off by Steve Wilson of the FDA.

During the first session, Malcolm Bertoni, M.S. (Director, Planning Staff, FDA Office of Planning) presented plans for improving the FDAs IT infrastructure and processes related to electronic submissions.

While Mr. Bertoni did not dwell on it, it is clear that much of FDAs plans to upgrade its IT capabilities rests on the ability to obtain funding from the Prescription Drug User Fee Act (PDUFA). The current version of this is PDUFA IV.

Top 12 Issues for eCTD Success

Last week marked the 20th anniversary of the annual DIA Document Management Conference.

Having had the pleasure of attending this event, I can now report to you on the key issues that the FDA has identified related to their experience evaluating eCTDs. The list was presented at the meeting by Ms. Virginia Ventura of the FDA Office of Business Process Support.

I am going to refrain from commenting on this list except to say that I am somewhat amazed that submitters would ever make such obvious mistakes.

See what you think.