Quality Control and Standard Operating Procedures
Recently, systematic reviews have found quantitative evidence that low study quality may have introduced a bias into preclinical stroke research. Monitoring, auditing, and standard operating procedures (SOPs) are already key elements of quality control in
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1. Introduction Thus far, the translation of promising results from preclinical stroke research into effective clinical therapy has not met with success (1). Among the numerous possible reasons for this failure, quality problems in some of the basic research or preclinical studies have to be considered. False–positive results, inflated effect sizes, and marginal reproducibility may have overestimated or even affected the potential of novel stroke therapeutics (2). Systematic reviews have found quantitative evidence that low study quality may have introduced a bias into preclinical stroke research ((3–5), and see Chap. 2). As opposed to many other causes of the “translational roadblock”, study quality is fully under the control of the researcher, and thus a prime target for improvement. Increasingly, funding bodies and review boards overseeing
Ulrich Dirnagl (ed.), Rodent Models of Stroke, Neuromethods, vol. 47, DOI 10.1007/978-1-60761-750-1_17, © Springer Science+Business Media, LLC 2010
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animal experiments are taking a proactive stance, and demand auditable measures of quality control in preclinical research (6). The Stroke Therapy Academic Industry Roundtable (STAIR) recently updated its recommendations for the evaluation of preclinical data on neuroprotective drugs (7) to include good laboratory practice (GLP) issues (8). Monitoring, auditing, and standard operating procedures (SOPs) are the key elements of quality control in randomized clinical trials (RCTs). It has been proposed that experimental stroke research adapt some of the tools used in clinical stroke research. In particular, stroke laboratories should set up and publish their SOPs (e.g., on their institutional websites), and guarantee that their studies adhere to these standards (9). This is all the more important, as a certain portion of their experiments, evaluations, etc., are not performed by professionals, but rather by students in training who are unaware of these issues. Write down what you do, do what is written down! It is the aim of this chapter to introduce the concept of using SOPs to improve quality control in experimental stroke research, and to provide practical advice on how to write them.
2. The Concepts Every good quality control system is based on its SOPs. SOPs are defined by the International Conference on Harmonisation (ICH) as “detailed, written instructions to achieve uniformity of the performance of a specific function”. They are necessary for a preclinical research organization – be it a pharmaceutical company, a contract research organization, academic laboratory, internal review board, funding organization, or any other party involved in preclinical research – striving to achieve maximum transparency, reproducibility, robustness, and efficiency in its preclinical research operations. Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this sta
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