Achieving faster study start-up is a hot topic in today’s clinical research environment.
One increasingly common method of saving time and increasing efficiency is the use of technology. Perhaps the most widely used e-tool in clinical research is electronic data capture (EDC) to collect patient data, which cuts down on transcription errors and enables virtual monitoring. A 2011 study by BB&T Capital Markets found that EDC is now used in approximately 75% of trials, compared with only 35% to 50% in 2005.1
In the next few years, two additional e-tools are likely to lead to significant changes related to start-up.
- First, electronic signatures will become more widely accepted, even by the FDA, which encourages sponsors to submit study reports electronically. With electronic signatures, the transmission of documents back and forth between the site and CRO will naturally move to a transparent environment, as will maintenance of site documents.
- Second, more sites will convert to electronic medical records (EMR) because of advantages for patient management and ease of transfer of information between providers. Ideally, a site’s EMR software will communicate with a trial’s EDC system, although that level of compatibility will probably take several more years to achieve.
Many investigators still typically use billboard postings and newspaper advertisements to spread the word about clinical trials. Data mining of EMRs can be used by investigators to identify patients who are candidates for upcoming clinical trials. However, there are a few points to keep in mind when using EMRs for identifying potential study subjects:
IRBs must approve the patient recruitment plan, and researchers are required to file an Application for IRB Waiver of HIPAA Privacy to be authorized to use protected health information for prescreening.2
Clinical trial alerts should be tailored to particular settings and frequencies to maximize their specificity and reduce alert fatigue.3
On February 14, please join me for a FREE webcast where I’ll share ways to achieve faster study start-up – The Joys and Woes of Clinical Trial Start-Up: A Global Perspective.
- PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2012/2013
- Hanrahan D. Electronic Medical Records in Clinical Trial Recruitment. Ethics Illustrated. http://www.bioethicsinternational.org/blog/2012/11/19/electronic-medical-records-in-clinical-trial-recruitment/. Accessed January 24, 2013.
- Hirsch MD. HER alerts help recruit patients for clinical trials. FierceEMR. http://www.fierceemr.com/story/ehr-alerts-help-recruit-patients-clinical-trials/2012-05-03. Accessed January 24, 2013.