The Laszlo Letter

The High Cost of Swimming Upstream with IT Projects

Setting the scope of an IT project is possibly the most important factor affecting it's chance for success or failure. While most project do end up delivering some benefits, they rarely deliver everything that was hoped for.

Even when projects succeed, we may still be left clueless about unintended consequences. This is the main point of an article I recently wrote in the June issue of Pharmaceutical Executive Europe called "The High Cost of Swimming Upstream."

Just click on the title to see the article.

Software for Clinical Development

Having recently particiapted in two DIA meetings, I thought it would be useful to pull together a spreadsheet of vendors offering software used in clinical development. This can serve as the basis for a more comprehensive list built and maintained by reader input.

For now, the list is kept in an Excel spreadsheet:

Download ClinDevSoftwareVendors-April2008.xls

Please note that I consider this spreadsheet as the intellectual property of The Laszlo Letter. In other words, it is copyrighted. You may use it as a reference document but not benefit from it in any financial manner or reproduce it without my permission.

To contribute new items or update those that already exist, just use the comment function of the blog. I will take it from there and post new versions of the spreadsheet as necessary.

Thanks in advance for your help.

Lilly: Implementing SAS Drug Development

Notes from the 23rd DIA CDM Conference

Susan Duke of GSK chaired a session on Tuesday, March 18th, called "Statistical Computing Environments: Collaboration through Metadata, People, Process and Software." During this session, Christopher Colangelo, Associate Senior Statistician, presented Eli Lilly's effort to implement SAS Drug Development (SDD) as a centralized but globally available repository for clinical data.

But first, and for those unfamiliar with this relatively new concept, a Statistical Computing Environment (SCE) is a combination of hardware, software and processes, that enable the collection, management, analysis, and transparency of operational data within a life sciences environment performed in compliance with government regulations and operating best practices. From a technical perspective, it is also an extension of a relatively new software category called "Clinical Data Repository" or CDR.

You can learn more about both SCE and CDR via the following posts on this web site:

• Clinical Data Repository (CDR) 101
• Clinical Data Repository (CDR) Vendors
• Of CDR, CDMS and EDC
• The EDC, CTMS, CDM Confusion
• DIA Reflections: The Importance of Semantics
• Genzyme: Biostatistics with Waban SCE

At Lilly, the selection of SDD arose from the recognition that internal staff in Data Management, Data Delivery, Statistics, Medical Communications and external partners such as CROs needed an environment that would allow for greater collaboration within a secure environment.

Patient (Self)Recruitment

Notes from the 23^rd DIA CDM conference

Sometimes we tend to forget that everything we do is for the patient.

I was reminded of this when listening to a talk by Laura Esserman of the University of California Medical Center at San Francisco. Dr. Esserman described her clinical work in the area of breast cancer and the recognition that patients themselves could be the source for electronic health records (EHR). Once collected, these records could be used to match patients to clinical trials. In other words, the EHR becomes the source of data for patient recruitment.

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).

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”

Apple iPhone: Life Sciences applications needed. Money available.

As you know by now, I am betting that the Apple iPhone will become an important communication and collaboration tool in our industry. This, in spite of many dissenting voices that the iPhone is not ready to handle real business applications.

Apple has now reported that over 100,000 downloads have been made of its Software Development Kit (SDK) since its launch on March 6th, 2008.

Now, Kleiner Perkin Caufield & Byers (KPCB) has launched a $100 million fund to support the development of iPhone applications. According to its web site, the fund "will invest in companies building applications, services and components. Focus areas include location based services, social networking, mCommerce (including advertising and payments), communication, and entertainment. The iFund™ will back innovators pursuing transformative, high-impact ideas with an eye towards building independent durable companies atop the iPhone / iPod touch platform."

According to the FAQ on the KPCB web site, the funding can be anywhere betweek $100K and $15M. The application form can be found here.

So, this is a great opportunity for all you entrepreneurs out there to show how the iPhone can be leveraged to support the R&D, Sales & Marketing and/or Manufacturing & Logistics segments of our industry. Even if you don't end up being funded by KPCB, only $99 stands between you and the SDK.

First, think BIG! Then start coding.

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.

.

.

.

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.