Clinical trials were conducted in 63 different sites where the study aimed at comparing the effects of two different antibiotics in acute exacerbations of chronic bronchitis. In one of the trial sites there were twenty specimens where the sputum had a rare organism and the antibiotic resistance patterns were identical.
Cause of the problem
The clinical trials for the particular site that showed similar patterns of antibiotic resistance for all the patients is not accurate and something must have been wrong during the testing of the antibiotic resistance on different specimens. Antibiotic resistance is the ability of bacteria and other pathogens to withstand the effects of antibiotics and may be due to genetic action or transfer of plasmid matter from one bacterium to another or simply due to natural selection (Wynn 2010). Different patients have different patterns of antibiotic resistance. The problem originated from the trial sites when the specimens were being collected. The appropriate clinical practices were not observed and thus the misleading research results. According to Khan (2009), the occurrence of identical antibiotic resistance pattern in all the samples could have been as a result of contamination of the specimens through use of the same non-sterilized clinical equipments such as collecting swabs. Use of one non-sterilized equipment, leaves stains of a particular strain of the chronic bronchitis bacteria in the equipment and contaminates all other specimens. This is evidence of poor clinical practices during the trials (Stuart 2006).
With such results from the trial site, the matter may be discussed with the microbial laboratory specialists. The specialists help to understand the occurrence of such results and the possibility of different individuals having the same pattern of antibiotic resistance. The matter may also be discussed with the heads of the research at the trial sites (Powell 2010). This is important to establish the manner in which the specimens were collected. As the research manager, one should ensure that clinical practices are up to the right standards to avoid contaminating the specimens and giving wrong results. The matter may also be discussed with the laboratory manager. This is because the laboratory staff could have contaminated the specimens by use of the same non-sterilized equipments (Mayers et al. 2009). The laboratory manager would assist to ensure that all the activities in the laboratory are up to the best quality.
Immediate cause of action
As the research manager, the most appropriate step to take is to temporarily stop the activities at the trial site. The efficiency of the investigators should be assessed to ensure that they are capable of conducting the clinical trials in an appropriate manner (Clinical case study series. 2009). The investigators should be in a position to meet the requirements of the trial and the expected standards. The next step is to establish the root cause of the matter so as to design the most appropriate cause of action. In the trial site where the specimen showed the same pattern of antibiotic resistance, all the study equipments should be discarded or sterilized and the trial re-conducted to determine the accuracy of the initial results (Bonilla & Muniz 2009). The trials should be monitored to avoid any errors and to ensure that the correct procedures are followed. The equipments should be used only once or sterilized if they should be used for a second time. This ensures the efficiency of the trial exercise and reduces the margin of errors to almost 0%.
Dealing with the situation
To efficiently handle such problems the company has an immediate error responsive unit. The unit responds to research problems swiftly and ensures that the results of the trials are relevant. It corrects any mistakes that may arise and ensures the capability of the investigators. In this case the unit should suspend all the activities at the trial site and assess the investigators to ensure that they can handle the task. It also provides other trial equipments and oversees that the study is completed efficiently (Lee 2009).
The corrective action plan
Data or samples from any trial site are the backbone of any clinical research. Therefore, all the activities should be conducted with high efficiency to avoid biased results (Spriet & Dupin-Spriet 2005). A comprehensive correction plan should be put in place. First, high quality operating procedures should be devised and implemented for quality clinical practices. Such procedures include, use of clean and sterilized clinical equipments in the clinical trials. The procedures should be designed in a medical and scientific manner considering the protocol for credibility. Secondly, the individuals conducting the research should be selected on basis of good conduct and efficiency. This ensures that the trials will be conducted in the best standards and reduces the errors. It also provides accurate test results (Kolman, Meng & Scott 1998).
The individuals should be trained and briefed on the study and what is expected of them. The research site should be assessed as a way of addressing the trial risks. In addition, there should be a risk management unit to address any risks and reduce their effects. The research managers should conduct frequent quality assurance checks at the clinical trial sites to monitor the activities and ensure the integrity of the trials. Quality should be ensured during the trials and all activities carefully monitored (Fortwengel 2004).
Quality clinical practices are the basis of accurate trial results. The problem of identical antibiotic resistance patterns is as a result of poor clinical management. This is because the equipments used in the trial were not properly cleaned before the trials thus contamination of the specimen (Hughes & Anderson 2001). Such issues should be addressed by the relevant bodies to prevent further errors or providing misleading trial results. Immediate corrective action like the suspension of the activities prevents further errors. A corrective strategy should also be designed to avoid such errors in the future clinical trials.
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Clinical case study series. 2009. Quality management in clinical trials.
Fortwengel, G. 2004. Guide for clinical trial staff: implementing good clinical practice. Basel: Karger Publishers.
Hughes, D. & Anderson, D. I. 2001. Antibiotic development and resistance. New York, NY: Taylor & Francis.
Khan, A. U. 2009. Current trends in antibiotic resistance in infectious diseases. New Delhi: I. K. International Pvt Ltd.
Kolman, J. Meng, P. & Scott, G. 1998. Good clinical practice: standard operating procedures for clinical researchers. Hoboken: J. Wiley & Sons.
Lee, M. 2009. Basic Skills in Interpreting Laboratory Data. Kansas: ASHP.
Mayers, D. L. et al. 2009. Antimicrobial Drug Resistance: Clinical and Epidemiological Aspects. Tokyo: Springer Japan KK.
Powell, D. J. 2010. Clinical Supervision and Professional Development of the Substance Abuse. Pennsylvania: DIANE Publishing.
Spriet, A. & Dupin-Spriet, T. 2005. Good practice of clinical drug trials. Paris: Librairie Luginbuhl.
Stuart, C. 2006. Assessment, Supervision and Support in Clinical Practice: A Guide for Nurses, Midwives and Other Health Professionals. Amsterdam: Elsevier Health Sciences.
Wynn, L. S. 2010. What is antibiotic resistance?