Computable Protocol Models for Interactive Trial Design
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COMPUTABLE PROTOCOL MODELS FOR INTERACTIVE TRIAL DESIGN MICHAELG. KAHNMD, PHD Vice President. Clinical Informatics. Fast Track Systems, Inc., San Mateo, California
Clinical trial protocols must clearly describe complex relationships between srudy events, treatments, patient safety and data collectiodmonitoring tasks. Protocol writers must be constantly aware of the trade-offs between scientific, regulatoq and operational requirements and constraints. Many features of a protocol’s design could impact on the likelihood of success when that trial is placed into the field. Yet, protocol authors often do not have access to information on potential operational issues as they write the protocol. Without this information, study designs that are scientifically sound may be exceedingly difficult or expensive to operationalize successfully. We present a new methodology for evaluating a protocol for operational clarity and risk assessment during the design of the protocol. We introduce a new technology based on formal computable models for representing clinical trial protocols and studies. In creating computable models, many operational ambiguities surface. From these computable models, numerous quantitative analyses can be performed to understand the key Operational assumptions and risk elements inherent in the proposed design. Because the end product is a structured protocol model, execution tools such as site management and study monitoring tools can be automatically configured to execute the model. Key Words: Computable protocol model; Formal analysis; Probabilistic simulation; Proto-
col quality
INTRODUCTION THE PROTOCOL DOCUMENT for a clinical trial is designed to provide guidance for a wide range of activities. Even the most basic protocol document must describe at least the study objectives, clinical hypothesis, experimental design, eligibility criteria, randomizatiodstratification procedures, treatment alternatives, and outcome/safety measures ( l ,2). The specific details contained within the protocol document are motivated
Presented at the DIA 37th Annual Meeting, July 7-1 1, 200 1. Denver, Colorado.
Reprint address: Michael G. Kahn, MD, PhD. Fast Track Systems. Inc., 1825 South Grant Street, Suite 310, San Mateo, CA 94402 (e-mail: mkahn8fasttrack.com).
by complex scientific, regulatory, or safety issues, which frequently are at odds in their objectives or requirements (3). Members of regulatory, clinical operations, data management, biostatistics, finance, legal, and drug manufacturing departments within the sponsoring organization must interpret different subsets of information contained in the protocol document. Each person involved extracts issues of interest to hisher area of responsibility and proceeds to create “trial artifacts” such as investigator contracts, model consent forms, case record forms (CRFs), data entry forms, data query criteria, schedules of visits and events, and manufacturing sch
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