The ClinPage Territory
CRO Department. According to the New England Journal of Medicine, contract research organizations (CROs) now handle at least 65 percent of all studies sponsored by industry. The CRO industry includes Fortune 500 firms with tens of thousands of employees—and specialist firms that focus on a therapeutic area, functional task or geographic region. The CRO industry must hew to strict time lines that sponsor companies cannot always maintain, raising the word “service” to levels not well understood outside the industry. To be efficient, of course, CROs must increasingly deliver technology on their own or partner with such firms.
CTMS Department. Clinical trial management systems (CTMS) are where everything comes together. An under-appreciated segment of the industry’s infrastructure, the CTMS can track just about everyone and everything involved in a trial. It may or may not monitor a variety of metrics about patient recruitment and whether payments are due to sites. Some newer CTMS tap into proprietary databases of prior trials to help plan patient recruitment or design the study protocol in a cost-effective, operationally efficient manner. An informal CTMS (an Excel spreadsheet with names, phone numbers and deadlines) remains a less-secure but common tool.
Eclinical Department. The industry is routinely asking for two or more technologies and services to be combined on the same trial. “Eclinical” is the most common term to point toward combined technologies that have not quite arrived but could be potentially transformative. Sponsors clearly articulate a desire for vendors to supply eclinical services and software that are easy to mix and match. The potential cost and labor savings that might be realized by avoiding the manual re-keying of data are large. But so is the magnitude of the difficulty of engineering these connections. Many clinical systems were never designed to link to a completely different type of database or application. Data standards offer one path to allow organizations to honor their own procedures and still get quickly up to speed with any firm participating in an eclinical project. This department was previously known as “suites.”
EDC Department. Electronic data capture (EDC) is the most transformative type of software that is changing industry-sponsored pharmaceutical research. The changes set in motion by EDC will ripple through the industry for years. Data managers, however, are already seeing their roles evolve. Most EDC suppliers still support paper forms, the contents of which are typed into a computer. Sites continue to wrestle with the technology. EDC systems generally facilitate cleaner trial data, faster database lock and greater visibility into trial progress. Perhaps half of all new studies use EDC—and, at a few large pharmaceutical companies, all trials employ it, leaving the late adopters scrambling to tweak their processes and learn about EDC.
IVR & Diaries Department. Interactive voice response (IVR) and electronic patient-reported outcomes (ePRO) are technologies that power the logistical and scientific aspects of trials. Telephone-dependent, but moving quickly to the web, randomization systems are poised for a higher profile in an age of adaptive trials. Drug supplies are often managed through the IVRS. The most advanced systems are cousins of CTMS, and can simulate different drug supply scenarios in complex trials. The ePRO sector is benefiting from regulatory officials who would like to nudge the industry away from paper-based patient diaries. How the ePRO data are collected is still in flux, with options including the plain old telephone, the internet browser, smart phone or tablet computer. The coming role of the patient’s own phone or even short message systems (SMS) is the frontier in ePRO.
Regulatory Department. Regulatory affairs drives much of what happens in every clinical trial. This department is where ClinPage tries to cover institutional review boards (IRBs) and stay abreast of both news about guidance from FDA and other authorities—and the systems used to manage documents, submissions and other communications. Software for regulatory professionals typically manages electronic common technical documents (eCTDs), regulatory submissions, trial master files and other documents. Some of these systems are increasingly used for project management as well, given the fact that projects and people in the industry need a variety of documents to move their projects forward.
Safety Department. From managing serious adverse events, both internally and with regulators, to proactively detecting signals of potential harm to patients, drug safety is probably the most scrutinized clinical trial subspecialty. Pharmacovigilance and the analysis of population-wide patterns has never been more complex, more urgent, more intertwined with the industry’s ability to regain the public trust. If the public understood how much of the data was still handled on paper and fax machines—wait. Let’s not go there. Recent federal legislation will eventually let the FDA use public databases to track drug safety issues, and industry will be obliged to do the same. The ability to focus on the most novel and scientifically important safety signals remains a challenge across the industry.
Statistics Department. In the end, it all comes down to the analysis of the data. Increasingly, data standards in the life sciences are expediting statistical analysis. Biostatisticians as a group remain in short supply. And adaptive trials, while little more than hyperbole to some in the industry, are the only glimmer of real hope that could someday significantly alter the time line of a typical clinical trial. Statisticians will have to be more involved in planning trials, insisting on data standards, and not cleaning up at the end of the process.
Trends Department. Clinical trials are exceedingly complex. Industry-sponsored projects are some of the most expensive, time-consuming scientific experiments conducted in any field. Our Trends department is where we cover substantive long-term issues of interest to the industry and society in general. The industry’s critics, academia, medical journals, Washington—all of it can indirectly affect the planning of trials and the way the industry is perceived.