eClinical Trials: Planning & Implementation

Rebecca Daniels Kush, with Paul Bleicher, Wayne R. Kubick, Stephen T. Kush, Ronald Marks, Stephen A. Raymond, and Barbara Tardiff (Thomson CenterWatch, Boston, MA, 2003), 200 pages, soft cover, ISBN: 1-930624-28X, $79.00.

This manual, according to its publisher, is the first-of-its-kind resource for biopharmaceutical companies, CROs, and investigative sites searching for guidance in implementing technology to accelerate and improve their clinical trials. The authors claim there is a great need for assistance in this area, particularly when one compares the progress of the financial community to the healthcare industry. Healthcare is clearly lagging behind, and most physicians do not even have electronic access to patient records. While it is unreasonable to expect the entire industry to move en mass to a paperless delivery system, clinical trials, say the authors, are a prime candidate for improvement.

Sponsors and CROs indicate that they are using eClinical technologies for 24% of phase 1–4 trials (up from 12% in 2000), and they anticipate using eClinical technologies for nearly half of their clinical projects by 2004 according to a 2002 CenterWatch/CDISC research project cited in the book involving approximately 750 organizations. However, more widespread implementation can lead to roadblocks. Proponents of eClinical trials face a myriad of hurdles, including disparate data systems, the lack of a link between healthcare data and clinical trial data, real and perceived regulatory risks, and, according to the authors, “the overall slowness of adoption that is characteristic of the pharmaceutical industry.”

The important topics that this book covers are: The Optimal Electronic Clinical Trial; Process Redesign and Supporting Technologies; Achieving eClinical Trials; Metrics for Electronic Clinical Trials; Performing Electronic Clinical Trials in accord with Regulations; Data Quality and Data Integrity; The Impact of eClinical Trial Technology on Safety and Surveillance and IRBs; Industry Data Standards; and Ensuring the Success of Electronic Clinical Trial Implementations.

Organizationally, the book benefits throughout from graphically distinguished “Notes” stressing important points and highlighting relevant research. Other favorable features of the book include flowcharts detailing current, paper-based clinical trial processes and eClinical trials. The book’s Appendix also adds value, particularly the Glossary, which, although offering very basic terms, also includes electronic terminology such as “Health Level Seven (HL7),” an application protocol for electronic data exchange in healthcare environments. The Traceability Matrix, which covers compliance to 21 CFR 11 rules involving electronic records, is another useful aspect of the Appendix.

In another section of the book—Guidance for Industry: Computerized Systems Used in Clinical Trials—issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data to the FDA are also addressed.

The book is a useful resource for those new to the eClinical trials industry as well as those already involved in planning and implementing eClinical trials.

The book’s accomplished authors include Rebecca Daniels Kush, PhD, a founder and current president of the Clinical Data Interchange Standards Consortium (CDISC).