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4.1 Computerized System Reliability in Clinical Research

David L. Banks, Charles Hagwood, Raghu Kacker, James Yen
Statistical Engineering Division, ITL

Paul Black, Leonard Gallagher, Lynne Rosenthal
Software Diagnostics and Conformance Testing Division, ITL

A two-day conference on software quality and reliability issues for clinical trials data was held at NIST on September 28-29. The invited speakers included David Banks, NIST; Lynne Rosenthal, NIST; Jerry Gleit, Pfizer, Inc.; Gregory Stone, Pfizer, Inc.; Deborah Fowler, Oracle; James McCormack, FDA; Tony Lachenbruch, FDA; Gene Miluk, Software Engineering Institute; Lee Evans, SAS Institute; and several others.

One central topic was the compliance burden put upon both the pharmaceutical industry and certain software vendors by new FDA regulations for software performance in clinical trials studies. Currently, these regulations require each pharmaceutical company that purchases software for clinical trial use from a vendor to conduct a separate assessment of the software production quality program maintained by the vendor. This is costly to the purchaser, and repeatedly expensive to the vendor, who must justify their compliance with FDA standards over and over again. The vendors (SAS and Oracle, in particular) would like to have a one-pass certification of their software products.

Another central topic concerned parallelism between statistical methods for certifying the safety of new drugs and statistical methods for certifying the reliability of software. The decision to release a piece of software is very similar to the decision to release a new drug--in both cases the consequences of error can be very serious, and in both cases it is difficult to correctly assess the risks. For drugs, the FDA has developed a four-step protocol for approval, which is strikingly similar to four steps that, more informally, are involved in producing software: in-house inspection, conformance testing, beta testing, and on-line bug reports. Perhaps the arsenal of well-understood statistical methods in clinical trials can be adapted to address software reliability.

There were 212 attendees, mostly from government (NIST and the FDA) and industry (pharmaceutical companies, SAS Institute, Oracle). The conference was sponsored by the Drug Information Association; the conference organizers were David Banks, NIST; Lee Evans, SAS Institute; Tara Khonsari, Pfizer, Inc., Gene Miluk, Software Engineering Institute; and William Woods, Neuroclinical Trials Center. The local organizer and host was David Banks.

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Date created: 7/20/2001
Last updated: 7/20/2001
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