Patient Safety: A Fundamental Aspect of Clinical Trials through A Review Of A Study On Canadian Adverse Events

Download Article

Authors : Pramod Kumar Jagannathrao Wable


Patient safety has received growing attention worldwide sin last decade or two in clinical research. Identification and immediate reporting of an Adverse Event (AE) has always been one of the key parameters to assess and observer patient’s safety in clinical research. Compromise to the patient safety was evident as critical violation of the International Harmonization Conference (ICH) - Good Clinical Practice (GCP) requirements of clinical research.

This review was written after comprehensive and critical assessment of the research conducted by G. Ross Baker This review provided a synthesis of key principles of identification of AEs and determination of their preventability. It examined detail article structure considering the sample size, research population and relevance to the research topic. The review further critiqued on the article authority and creditability of the journal to authenticate the research. This review also commented on the other relevant advance researches conducted in the area of AEs within clinical research as a detail comparison.

It was concluded in this review that research conducted by G. Ross Baker was critical in terms of improving attention towards patient safety in clinical research and community services.


[1.] Agoritas, T., Bovier P.A., & Perneger T.V.,(2005).Patient reports of undesirable events during hospitalization. J Gen Intern Med; 20: 922-928.

[2.] Aranaz-Andrés, J.M., Aibar-Remón, C., Vitaller-Murillo, J., Ruiz-López P., Limón-Ramírez, R., & Terol-García E; (2008). ENEAS work group. Incidence of adverse events related to health care in Spain: results of the Spanish National Study of Adverse Events. J Epidemiol Community Health. ;62(12):1022-9.

[3.] Brennan, T.A., Leape, L.L., Laird, N.M; Hebert, L., Localio, A.R, & Lawthers A.G., et al.(1991). Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med;324(6):370-7.

[4.] Canadian Medical Association Journal, retrieved on 29 January 2014.

[5.] Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance, retrieved on 29 January 2014

[6.] Leape, L.L., Brennan, T.A, Laird, N., Lawthers, A.G., Localio, A.R., & Barnes, B.A., et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II.N Engl J Med 1991;324(6):377-84.

[7.] Masotti, P., Green, M., Shortt, S., Hunter, D., Szala-Meneok, K., Adverse events in community care: developing a research agenda. Healthc Q. 2007;10(3):63-9.

[8.] Murff, H.J., Patel, V.L., Hripcsak, G., Bates, D.W., Detecting adverse events for patient safety research: a review of current methodologies. J Biomed Inform 2003; 36: 131-143.

[9.] Robert, J., Adams., Graeme Tucker., Kay Price., Hill,C.L., Appleton, S.L., Wilson, D.H., Taylor, A.W., & Ruffin,R.E.,(2009). Self-reported adverse events in health care that cause harm: a population-based survey, Med J ; 190 (9): 484-488.

[10.]   Scott, I.A., Ward, M.,(2006). Public reporting of hospital outcomes based on administrative data: risks and opportunities. Med J; 184: 571-575.

[11.]   University of Toronto, retrieved on 29 January 2014.

[12.]   Vincent, C., Neale, & G., Woloshynowych, M., (2001). Adverse events in British hospitals:

[13.]   preliminary retrospective record review [published erratum in BMJ 322:1395.

[14.]   Vincent, C.A., & Coulter, A.,(2002). Patient safety: what about the patient? QualSaf Health Care. 11: 76-80.

[15.]   Wilson, R.M., Runciman, W.B., & Gibberd, R.W., et al. (1995).The Quality in Australian Health Care Study. Med J; 163: 458-471.

[16.]   Weingart, S.N., Callanan, L.D., Ship, A.N., & Aronson MD. (2001). A physician-based voluntary reporting system for adverse events and medical errors. J Gen Intern Med; 16: 809-814.

[17.]   Woods, D.M., Thomas, E.J., & Holl, J.L., et al. (2007) Ambulatory care adverse events and preventable adverse events leading to a hospital admission. QualSaf Health Care; 16: 127-131.