By David Stein and Bill Byrom
April 15, 2005 | The pharmaceutical industry is often criticized for its slow adoption of new technologies, particularly in the areas of electronic data capture (EDC) and electronic diary systems. Many vendors focus on helping the industry implement a wide array of solutions and consulting firms charge high premiums for giving advice on building a complete end-to-end e-clinical solution.
Meanwhile, investigative sites are charged with new processes to enter and clean data on a variety of EDC platforms. Sometimes they are asked to train patients in the use of technology, and set up and distribute electronic devices to their patients. At other times, they must enter the same information in more than one electronic application, such as within an interactive voice response (IVR) and an EDC system, to satisfy the requirements of the study. Data management departments struggle to reconcile and to map data from front-end systems to their back-end databases.
With so many technologies and systems available, it is critical to focus on the needs of the wide variety of stakeholders in the clinical trial process. Sponsors need trials to run quickly, from enrollment through to database lock. Investigators want systems that make their lives easier and their work processes more efficient. Patients want good healthcare and minimal inconvenience. Are the majority of solutions today meeting these needs? In many ways, the key customers in this mix are the site and the patient, and their commitment to the clinical systems is critical to success of any trial.
Flexibility: Providing Ease of Use
For more than a decade, IVR systems have helped sites to randomize patients, dispense medication, and automate the stocking of clinical supplies at study sites and depots. Investigators benefit by reducing medication storage requirements, eliminating the need to request new supplies of medication, simplifying expiration date re-labeling activities, and conducting emergency code (blind) break procedures by telephone.
Clinical sites are increasingly Web savvy. To meet their needs, sites should be able to access their electronic trial management applications not only by telephone, but also via the Web using interactive Web response (IWR; see Figure 1). However, use of the Internet cannot be imposed on all sites. Web access is poor or nonexistent in some countries in which trials are being conducted. And not all sites have suitable terminals in the same area where they meet with patients, such that the telephone is still the most convenient method to use. For example, site personnel can’t be expected to travel to another area of their facility to find a Web-connected computer when randomizing a subject. Therefore, the most useful solution is to allow these investigators to randomize via the phone or the Web, whichever they find most convenient.
Eliminating Duplication of Activities
The use of technology should simplify working processes and make them more efficient. Although this is generally true with EDC, some of the work is simply shifted to become the responsibility of another user. For example, data are rarely entered directly into an EDC application; typically they are written on paper worksheets first and later keyed into the electronic case report form (eCRF). In addition to conducting the study, site coordinators are required to perform timely data entry. Although many sites are enthusiastic about EDC, when additional technologies are included in the study it could duplicate activities as each system requires certain data and updates.
Consider a site coordinator who randomizes a patient using an IVR system. The IVRS gives the coordinator a randomization code, and a medication pack number is written on a form or worksheet. Later, the coordinator logs on to an EDC application and enters this same randomization number and dispenses information into an eCRF. This common situation may not sound too bad (after all, it takes the coordinator only a few minutes to record the randomization number and medication pack number twice). However, there is a possibility that he or she may enter the number incorrectly. Thus, a quality assurance process is needed to check for discrepancies between the IVR and EDC systems. Further, if an error is found, someone must correct it and ensure that the audit trail is maintained.
At ClinPhone, we have developed a generic integration module that enables IVR studies to exchange data in real time with many other clinical applications, including EDC and clinical trial management systems (CTMS). Data exchange occurs in either direction, as defined by protocol and working practice requirements, so that duplication in activities is eliminated. Integration of clinical systems simplifies processes and brings benefits to all involved.
Easy-to-Use Patient Diaries
Another practical use of IVR is for patient diary collection. These systems are simple and intuitive and have been used in clinical studies for well over a decade. Study subjects consistently report that IVR diaries, and even sophisticated clinical assessments delivered by phone, are easy to use. To be successful, service providers must deliver solutions that simplify and accelerate clinical processes. Clinical systems and applications must focus on the end-user, the site, and the patient.
David Stein is director of product strategy with ClinPhone, Princeton, N.J.; Bill Byrom is director of product strategy with ClinPhone Group Ltd., Nottingham, England. E-mail: firstname.lastname@example.org.