CenterWatch Commentary
- The Psychology of Clinical Trials: Understanding Physician Motivation and Patient Perception
- Time To Embrace Paperless Clinical Trials
- We Found The Best Clinical Site Sponsor Cos
Time To Embrace Paperless Clinical Trials
This article was first posted on the Thomson Bio/Pharma Forum, http://forums.thomson.com/biopharma/index.aspx. In this article, Steve Zisson of Thomson CenterWatch weighs in on electronic data capture companies.
When it comes to efficient drug development, pharmaceutical companies have a lot to learn. Recent research we conducted at Thomson CenterWatch suggests, however, that they might just be getting the message, at least when it comes to clinical trials.
In a recent survey, we polled users of electronic data capture (EDC) software – the folks on the front line of research who conduct their clinical trials using this software – for their views on the factors most likely to prevent future drug development delays. Their top answer: EDC software. When we conducted the same survey in 2003, EDC software came in fourth.
That's not to say that the industry has embraced the technology yet – only about 10% of clinical trials are currently done electronically. But the results of our survey certainly show a readiness to embrace an electronic trials process, unsurprising given the immense pressures on pharma companies from the courts, regulators, investors and the public at large. Paper trials, it seems, must end.
Two recent quarterly reports from small EDC companies support the idea that biopharma is getting serious about efficient drug development. Phase Forward and Datatrak both posted solid revenue gains, with Phase Forward showing a 17% jump in third-quarter revenue to $22.2 million and Datatrak growing revenue by 36% to $4.1 million.
EDC companies bear watching for what they say about how pharma is re-engineering the drug development processes around EDC. We all know that developing a new drug is expensive. This software helps when pharma's clinical research processes are reworked to reflect its adoption. One of the primary benefits for pharma from EDC is being able to make drug safety decisions on quality data early in the development process in real time.
Sure, these companies are small, and there are some hurdles they'll need to clear to become viable large-scale solutions. Most EDC companies, for example, still don't offer enterprise-wide solutions. Competition is also fierce among a number of public companies, including eResearchTechnology and soon-to-be public etrials, and small private companies such as Medidata Solutions and Datalabs, not to mention software giant Oracle. That is part of the confusion for pharma. With 20 vendors in this space, there are simply too many choices.
We will be watching investigators and small EDC companies for signs of which biopharma companies are getting their drug development processes right. Because the drug researchers that do may be recording the kinds of profit gains pharma companies posted regularly in the bygone era of blockbuster drugs.
Steve Zisson is managing editor of Thomson CenterWatch.
We Found The Best Clinical Site Sponsor Cos
The folks at Thomson CenterWatch looked at which sponsor companies work best with clinical research sites in CenterWatch's annual survey of site professionals. Here’s what they found:
Contract and budget issues for sponsor sites are most likely to bog down clinical studies, but Wyeth is one of the best in the industry at managing the process.
So say researchers and administrators at 612 clinical sites we at Thomson CenterWatch surveyed recently. We asked these front-line professionals which sponsor companies work best with investigative sites and found that overall, Wyeth, Lilly and Genentech came out in a dead heat at the top of the rankings.
Lilly is no surprise, consistently ranking among the top three in our annual survey, but Wyeth's shot to second this year is a wake-up call for the rest of the industry – Wyeth finished dead last in our 2003 survey.
Through its "Clinical Breakthrough" program, Wyeth has introduced significant changes to its contract and budget negotiation processes—an area in which it excelled in our survey—including in its sponsor-site contract.
Our survey respondents rated these negotiations as the number one factor leading to study delays, which can have broad implications for the drug development process, including holding up patient recruiting and enrollment, not to mention adding expense.
For Wyeth, getting the site contract right has helped. The company's old contract was 17 pages and difficult to read without a legal background. It revamped that contract to 12 pages in plain English. It also changed its negotiating approach to sites. Instead of negotiating site by site, it's now offering what it believes is a much fairer package up front.
Other biopharma companies would do well to follow Wyeth's example of self-examination and solution. The contract and budgeting process is so often needlessly delayed by sponsor companies out of touch with investigators at these sites. Companies should know how long certain tasks take and pay appropriately to carry them out according to Good Clinical Practice (GCP).
Many in the clinical research industry believe that a standardized, industry-wide contract is the solution. In the meantime, there is plenty biopharma companies can do to make the contract negotiation process run more smoothly. The development process depends on it.
By Sara Gambrill, senior editor, and Steve Zisson, managing editor, of Thomson CenterWatch, which publishes newsletters and market research covering the clinical research industry.
