In a new survey of 598 investigator site personnel, there is an unhappy snapshot of the most oppressed and disgruntled segment of the clinical trial workforce.
According to the survey, clinical sites are aware of using the Internet to collaborate and manage industry research. But investigators and their staff feel the sponsor community is still too prone to use paper-centric processes that the colonial-era John Hancock would have understood.
As an electronic document management company, IntraLinks (which conducted the survey with CenterWatch) has a dog in the hunt to find more efficient ways of working. The New York City firm honed its technology in serving the financial services industry. In some corners of the banking industry (mergers, for example) there is almost entirely electronic-based document sharing during the deal making process. But now IntraLinks has solutions for a variety of other industries and connects 195,000 different organizations in 60 countries.
In the clinical trial realm, IntraLinks has a specialized product. Its survey suggests a significant degree of inefficiency is embraced in many clinical research projects. Few readers will be shocked, shocked by that assessment. Indeed, an unknown percentage of jobs in clinical trials are predicated on inefficiency, dependent on inefficiency, and such positions seem immune to corporate cost-cutting, possibly because senior managers have no idea where the dead wood is located.
In the survey, almost three-quarters of respondents still receive documents by overnight courier, fax and email attachment. Fifty-nine percent of respondents track project due dates, status reports and other milestones manually, i.e. using paper or a white board.
Instead of being productive, two thirds of respondents search for lost documents as few as two or as many as nine hours per week. That's work for which sites might not be reimbursed, underpinning negative emotions related to participation in clinical trials in general.
Three quarters of respondents resend documents to a contract research organization (CRO) or sponsor again, a second time, at least once per week. It's a given that the document was misfiled, misrouted or otherwise lost in the first attempt.
The respondents in the IntraLinks survey were productive and sophisticated, with 87 percent of them reporting involvement in more than 15 studies over the past year. More than half of the sites that were surveyed are running 4 to 15 trials at once.
Linda Bowers, VP of life sciences product marketing at IntraLinks, says the survey shows investigators are receptive to working with documents stored in the data cloud. "There is a willingness to leverage online tools," she says. "There is an appetite to improve the efficiency."
Contrary to one or two other technologies that sites still resent, with the poster child being electronic data capture (EDC), electronic document management doesn't alarm site personnel. "There are not a lot of barriers," Bowers adds. "There is not a lot of resistance."
Bowers says that the company is able to absorb information flowing from a few top clinical trial management and drug safety portals, minimizing the number of systems investigators need to interact with. If the investigator is working with multiple sponsors that all use IntraLinks for documents, there is only one password needed.
IntraLinks is working especially closely with Microsoft SharePoint. Bowers says IntraLinks can securely give SharePoint access to partner organizations outside the corporate firewall (think clinical sites, CROs or institutional review boards).
An example: If an investigator is brought aboard a trial that is already under way, she notes, it is simple to give the new researcher access to IntraLinks/SharePoint, and be certain that all of the trial's key documents are seen and reviewed by that individual. It's worth pointing out that handling the same set of onboarding activities and document deliveries the quick and dirty way, via email, may or may not be compliant with key U.S. regulations, and is certainly less secure.
Bowers notes that for IntraLinks users with Blackberries, iPhones and iPads, the company's system has been tweaked for full functionality on a mobile or tablet device. Good experiences on popular, portable platforms are still on the to-do list of many clinical trial technology companies, which have generally allocated their R&D budgets toward optimizing their systems for browser-based access. d9A2t49mkex
The sole positive note in the IntraLinks survey was that a quarter of those surveyed use web-based methods as their primary method of exchanging clinical trial documents. That implies that a few sponsors are finding ways to avoid the dreaded black holes called fax machine and FedEx boxes. One wrinkle to using the web for signed documents, of course, is understanding the nuances of digital and electronic versions of signatures. Big systems can handle authentication and digital John Hancocks automatically. But the SAFE-BioPharma Association can also provide background information.d9A2t49mkex