EXCLUSIVE: eCliniqua CTMS Survey Results

eCliniqua's survey of the clinical trial management system (CTMS) market has now concluded. We're grateful to the 108 people who took the time to fill out a dozen questions. We hasten to note that our survey was designed by a rank amateur at surveys. That would be us. As a result, our methodology and answers would surely fail any test for scientific rigor. All the same, there are some intriguing tidbits.

First, a bit of information about the 108 who took our survey. Some 63 percent of our respondents reported they worked for organizations with more than 500 employees. Fourteen percent worked for organizations with 100-499 employees. Just 23 percent of those replying worked for organizations with 1-99 employees.

By organization, half of the respondents were from pharmaceutical or biotech companies, 19 were from contract research organizations, and the remainder consisted of a beloved but motley assortment of observers and hangers-on-vendors, consultants, and clinical site personnel.

At times, clinical research organization (CRO) and pharma/biotech respondents to our survey saw the questions in exactly the same way. In both camps, for example, non-CTMS systems are taking on the functionality of a CTMS, according to roughly 85 percent of those surveyed. Must a CTMS integrate with other systems? Again, 95 percent of our respondents say that that is the case.

But there are divergences between how the pharma/biotech folks and the CRO folks see the CTMS landscape. Are our respondents happy with the CTMS landscape? Yes, generally. There is no great upwelling of discontent.

Among all respondents, 32 percent reported being very happy, 26 percent reported being content, 32 percent reported moderate unhappiness-and just 11 percent reported being very unhappy. But the figures skew slightly toward more unhappiness among CROs, with 42 percent of those respondents reporting moderate or extreme unhappiness. Among those in pharma and biotech circles, just 24 percent of respondents had such feelings. That suggests opportunities for CTMS vendors specializing in helping CROs.

There was a similar gap when we asked what types of tools were being used as a CTMS. Among pharmaceutical and biotech respondents, only 2 percent were using Post-it notes, loose-leaf binders, white boards, and their ilk. The figure was twice as high among CROs. Nine percent of pharma/biotech respondents were using Microsoft Excel documents, but 16 percent of CROs reported using spreadsheets. Eighty percent of pharma/biotech companies reported using commercial CTMS software; the figure was 42 percent among CROs. An in-house database was used at 9 percent of pharmas and biotech companies, vs. at 37 percent of CROs. The survey thus appears to confirm a prevailing view in the industry, which is that CROs underinvest in technology for many structural and cultural reasons. (If you work for a CRO that breaks the mold, go ahead, let me know.)

Many of our questions were multiple-choice. But in one item, we forced respondents to pick the single most important feature of an ideal CTMS. CROs tended to weight all factors relatively evenly, with such features as managing one project, managing multiple projects, and monitoring patient recruitment being equally important priorities. For biotech and pharmaceutical companies, however, 40 percent of those respondents picked managing multiple trials as the runaway leader and most important feature. As one might expect, monitoring site and investigator improvement was three times as important to pharmaceutical and biotech companies as it was to CROs.

In a future edition of eCliniqua, we'll provide more details about the popularity of specific features and functions. Those data are straining our small brain, and we will solicit more expert voices to help us analyze those questions. In April, we'll also report some of the fascinating free-text comments supplied by respondents. Again, warm of thanks to everyone who filled out our survey. Ideas for additional surveys should be sent to the editor.

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Winchester Business Systems: Don't Try CTMS at Home

The main joy of television, whether it be the Winter Olympics or "American Idol," is in sitting in one's recliner, refreshment in hand, and thinking to oneself, "How hard could it be to ruin that song?" or "How hard could it be to grab that board while it slides down the mountain?"

The clinical trial management system (CTMS) space inspires similar sentiments. Many vendors from other niches of the clinical technology landscape sit on their sofas and ask, "How hard could it be to take what we have and call it a CTMS?"

Plenty hard, suggests Mike Regentz. He's managing director, Winchester Business Systems. They're outside Boston. Basically, Regentz suggests, you're all welcome to try CTMS. Go right ahead.

"You want your CTMS to be aware of, and alert clinical trial management, that things are going to happen. It's anticipatory," says Regentz. "There is management and science to trials. The CTMS applies the management." The CTMS should handle payments, investigator documents, study protocols, recruitment milestones-the whole nine yards.

Regentz believes that the CTMS industry will evolve much as enterprise resource planning software did. It will absorb other technologies. He describes many other aspects of clinical trial technology as "fringe" topics. Like what? Well, electronic data capture (EDC). "I hate to say the EDC guys had the easier road, but they did," he notes. He's got nothing against EDC, mind you, and credits such companies with important contributions to the industry and patient safety.

But he does think that what any CTMS delivers is trickier. Periodically, Regentz has entertained EDC companies, supplying a briefing on what a full-featured CTMS should do. Often as not, such visitors recoil in horror at the sheer profusion of approaches to ostensibly simple tasks. Things like tracking investigator payments.

Early on, he says, Winchester Business Systems figured out some clinical investigators have a creative solution to delays in payments. As a quarter ended, they would fill in the header information in a case report form, leaving the impression that a patient visit had occurred. But on a monitoring visit, it would become clear that the actual encounter had not happened.

A better approach, Regentz would say, is to know what work has actually been performed, and pay accordingly. Technology can help here. "Investigators pump in the header of the case report form page in advance," he explains. "The patient didn't actually come in yet.  It turns out that without a CTMS, the financial person at the pharma company cuts him a check."

Or consider plain old document management-whether in paper or electronic format. Can you find the documents you need? Is it possible to reuse some of the same text? Many companies can't. Once there is a protocol, can a budget be generated? Can varied and complex scenarios be anticipated, automatically, based on the budget and the protocol being in the same system? Much of the industry is winging it, Regentz says. "A lot of it is still by the seat of the pants," he contends.

Many generic reporting tools (from Cognos or Crystal), he says, are impressive on their own terms. But ordinary users struggle with them. " Many of our smaller clients complain they need an engineering degree to use those things," Regentz says. "Since they don't use them frequently, they don't feel comfortable."

Regentz is surprised by how many sophisticated companies misuse Microsoft Excel. The issue is not so much that Excel is bad. It isn't. Winchester itself exports data into Excel. There is abundant functionality to the application if its limits are understood.

Rather, the issue with Excel is consistency and regulatory compliance. After all, only one person can use any spreadsheet at a time. Which leads to well-meaning colleagues keeping similar data about say, a particular investigator in Ohio. There is no way to validate which of four different spreadsheets is correct. His company, Regentz says, has learned the hard way about multiple discrepancies that tend to accumulate as four users on the same trial each hoard four piles of data in four precious XLS documents. He won't touch whether that's in compliance with 21 CFR Part 11. Ask your in-house expert.

Regentz is pleasant and affable, but it's clear he thinks that amateurish approaches to CTMS pose high risks. "When we've tried to import [from Excel], we've found that all four spreadsheets have different information," he says. "They've been keeping records on the wrong person for the 1572 [investigator] forms, the IRB approvals. The exposure you face is that the information you've received may be from an unverifiable source. When you go to import this data into a real database, you find out how much of it is incorrect. And yet they have been running Phase III trials based on that data."

Don't even get him started on email. "The FDA has made the statement that email is not a secure source of data," he says. " I don't know how many prospective biotechs we meet with who say, 'I manage the entire trial with email and the Internet.' " He rolls his eyes.

This is not to suggest he's against the Net. Says Regentz: "Our system is 100 percent online. If you want to analyze things on line as they're happening, you can manage your world in a more real-time fashion."

E-Clinical Trial Lineup at Life Sciences Expo Register now for our upcoming Life Sciences Conference + Expo (April 3-5, Boston). Go to http://www.lifesciencesexpo.com/live/26/ for more details. The E-Clinical Trials and Research track, which has been co-organized by Becky Kush (CDISC) and Ken Getz (Tufts CSDD), features the following outstanding speakers and topics: * Landen Bain (Topsail Technologies) Single source and an IHE profile for clinical research * Michael Barrett* (Critical Mass Consulting) TBA * Paul Bleicher (Phase Forward) Integrating EHR and EDC: Holy Grail or tilting at windmills?  * Jason Burke (SAS) Is industry ready for an interoperability platform? * John Cline (eTrials) Driving eClinical efficiencies and ROI: CRO and vendor partnerships  * Ramon Dempers (ICM Corp.) Integration to ensure effective drug safety/clinical trials * Don Detmer (AMIA) Beyond trial registration: A global trial bank for clinical trial reporting * John Halamka (Harvard Medical School) The HIT standards panel * David Hardison (SAIC) The emerging role of eClinical research data in healthcare * Ed Helton (SAS) Pharmacovigilance, safety, and clinical intelligence * Alan Hochberg (ProSanos) The future of safety data: SRS in an EMR world * Charles Jaffe (Intel) The global trial bank initiative * Rebecca Kush (CDISC) Progress report on standards: CDISC and HL7 RCRIM * Paul Lammers (Serono) Clinical trials in an electronic era * Gary Lubin (Merck) Capital flows 'upstream' * Charles Mead (Oracle) Semantic interoperability between life sciences and healthcare: Hurdles, realities, and promises * Jean Paty (InVivoData) Electronic patient reported outcomes: Documenting the ROI * Carol Rozwell (Gartner) Creating a clinical trials information management strategy for fun and profit * Uwe Trinks (Sentrx) Clinical trials 2010  * Robbert Van Manen (Lincoln Technologies) Optimizing clinical intelligence in signal detection using hierarchically structured thesauri * Deborah Zarin* (NIH) The International Clinical Trial Registry Platform   (*invited)

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