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March 2007

SecondStory Health raises awareness of the risk of medication errors during clinical trials

Are clinical trials keeping up with national patient safety practices?

Charleston, SC., March 28, 2007

At a recent clinical science training course for researchers, sponsored by the Society of Clinical Research Associates (SoCRA), John Kessler, Pharm. D., Chief Clinical Officer of SecondStory Health, LLC, addressed the risks of medication errors that can occur during clinical trials.  Sponsors, investigators, research personnel, and oversight groups such as the Food and Drug Administration (FDA) and Institutional Review Boards (IRB) have an ethical duty to minimize the risk to subjects enrolled in clinical trials.  These efforts are usually directed at controlling the known risks of research such as excluding persons who may be allergic to the study drug and excluding subjects diagnosed with concurrent diseases that increase the subject’s risk.  Similarly, the unknown risks are minimized by careful patient monitoring so that adverse effects are detected at the earliest possible time.  A key message during the course was that researchers should learn and understand the risks of latent error and system failure in the design, procedures, equipment, forms and policies of clinical trials.  These potential errors and failures increase the risk for medication errors, adverse events (i.e. preventable subject injury) and unanticipated problems. 


The course discussion examined an apparent gap between advances in the national patient safety movement and the current state of clinical research.  Medical errors and medication errors, in the context of clinical trials, are for all intents-and-purposes, an unexplored topic; yet several published reports describe frequent or severe medication errors, some that resulted in the subject’s death.  In one large international cardiology study, 11.5% – 13.5% of subjects experienced a known medication error in the dosing and/or administration of the study drug.  In another brief report, a patient died as a result of a medication error during a peanut immunotherapy trial.  Most widely known, is the death of the Boston Globe health reporter, Betsy Lehman, directly caused by series of medication errors.  The presentation examined the underlying system failures and latent errors in these cases, and research studies in general.


Dr. Kessler discussed the recent guidance on reporting unanticipated problems issued by the National Institutes of Health’s (NIH) Office of Human Research Protections (OHRP).  The updated guidance reinforces the need for researchers to monitor for and report unanticipated problems that occur during the course of a clinical trial.  Federal regulations specifically include medication errors in the definition of unanticipated problems.  Unanticipated problems do not have to result in harm to be reportable events.  OHRP’s compliance office however, commonly finds that investigators and institutions fail to report these problems as required.


The course concluded with a review of safe medication practices applicable to clinical trials and forecasts on the role of the IRB and the sponsor in assuring that subjects are protected from unnecessary known risks, unknown risks and preventable injury.

About SecondStory Health, LLC

Founded in 2003, SecondStory Health develops and implements effective software and strategies that help organizations discover the hidden causes and costs of adverse events. Their reporting, analysis, and peer review software reduces the incremental cost of errors and leads to improvements in patient safety. Their clinical and management consulting services link customers to a full range of advisory, analytical and database management services, customized to meet customer-specific needs.  SecondStory Health's principals have a combined total of more than 50 years of experience with complex system design, medication safety, pharmaceutical care, information technology design and systems implementation. SecondStory Health is located adjacent to Research Triangle Park in Carrboro, NC.  For more information, visit

About Society of Clinical Research Associates, Inc.

SoCRA. is a non-profit, professional organization dedicated to the continuing education and development of clinical research professionals. There are more than 8663 Members and 5,060 Certified Clinical Research Professionals "CCRP".  SoCRA sponsored over 30 educational programs in 2006 and established more than 50 examination sites.  The express aim of SoCRA is to provide training and continuing education for clinical research professionals and to establish and maintain an international certification program for clinical research professionals. For more information, visit