Info & Opinion
June 26, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
If one wants to launch a study on a treatment for Type 2 diabetes, and one desires to know how long it will take to enroll patients in, say, Brazil vs. India, the avenues for obtaining that information have been limited. Not anymore.
The consulting, benchmarking and analytics firm KMR Group has launched a service called SiteView that lets sponsors access just such data.
“It's a way for sponsors to look at how long it takes to recruit for a trial, and to assess that at site level,” says Linda Martin, principal and one of the founders of Chicago-based KMR.
SiteView subscribers can look up start-up times by therapeutic area, disease area, geography, or all three, and the tool displays the aggregated median number of subjects that any given site would be expected to recruit in a particular region.
“We know when [sites] started enrollment, when they randomized the first subject, how many dropped out, how many were screened,” says Martin proudly.
How does one consulting firm know all that? Because it's been amassing detailed data on completed trials from the top 20 pharmaceutical companies since the mid-1990s. Its database has robust and granular details from 10,000 studies conducted at close to 100,000 sites, parsed by KMR analysts using statistical methods.
SiteView is useful for planning and forecasting. It provides a fact-based approach to challenging assumptions about recruiting in various countries, says Martin. “You could look at it and say: 'In Asia, you see a much larger volume of patients per site,' ” she explains. “Then you can start planning for volume. If I need 100 patients, I might just need five sites in Asia, whereas I'd need more elsewhere.”
Specifically, SiteView answers these questions about various therapeutic areas and geographical regions: What is the typical volume of subjects randomized? How long can I expect any given site to be engaged in the recruitment process? What is the typical rate of recruitment? And how do these statistics vary by region or country?
SiteView is part of KMR's Enrollment Metrix, which also includes four-year-old TrialView—a product that allows subscribers access to broad performance metrics related to study start-up times. The sponsor data are transferred to KMR electronically, not manually, and the firm runs extensive quality checks against the provided information to be sure it is correct.
Next month, KMR will launch Site Scorecard, which will allow subscribers to see individual site data, comparing research locations. That will allow sponsors to quickly identify the top 10 recruiters in, say, small-cell lung cancer in Poland. The Scorecard can numerically rank a sponsor's sites and compare them to other sites in the database.
All For One
In addition to subscribing to the service, customers must join the community of sponsors that annually contribute their trial data to the database. The data are blinded, so that other companies don't know who said what about whom. Some metrics are only shared with the company that provided them; others are aggregated from multiple sponsors for the benefit of all the participants in the process.
KMR's customers share the goal of contributing to a robust database for the entire industry. To that end, KMR conducts a performance improvement study with participation by the top 15 pharma companies. The information the companies supply is sensitive. When the results are compiled, the individual companies can see where they and their sites rank in relation to peers—they just can't know exactly who their peers are. “They can see that they're number five on the list, but they can't see who numbers one, two, three and four are, and so on," says Martin.
KMR Group was founded in 1991 as a management consulting firm for the pharmaceutical industry. Its main focus: process improvement. But soon the principals realized that better benchmarking was needed if process improvement was really to be had.
“There just wasn't much good information in the marketplace for helping us decide whether a company was performing on par or better than their peers,” recalls Martin. So KMR launched its benchmarking efforts, which have accounted for most of the firm's work since 1995. Unlike other companies that focus on benchmarking in the pharmaceutical industry, KMR's data is not mined from publicly available sources. With such sources, “there's no way to validate it with a third party,” says Martin.
Thus far, KMR only works with pharmaceutical companies—not contract research organizations (CROs). That hasn't been the firm's preference. “We'd love for CROs to be more interested in comparing themselves to each other,” says Martin. “I think companies have become attuned to measuring just their own performance, and there's hesitancy to look at how they look next to their peers.” Firms like ClearTrial, out of Chicago, and Medidata Solutions, in New York City, do offer comparative CRO costing data and associated trial-design consulting, though.
KMR is about to launch a study to scrutinize exactly what pharma companies are doing to manage the outsourced aspects of research. That project will ask an eminently practical question: was the quality of the data in the outsourced studies better than studies the sponsor conducted itself?
In addition, KMR is about to release an analysis of enrollment metrics. “We're trying to figure out exactly why some companies are able to recruit more quickly than others,” says Martin. Among the issues to be probed: Does conducting a trial in multiple countries result in delays? Or are some companies just better at navigating the intricacies?
—by Suz Redfearn