Testing Drug Safety and Efficacy by Martin King
Article Summary
In this article, King, (2010), explores how general practice nurses (GPNs) and general practitioners (GPs) can work with CROs (Contract Research Organizations) and also how patients are selected in participation in clinical trials. The trend in patient treatment leans towards personalized treatment. This is because patients respond individually to treatment as a result of various factors like genetic make-up, status of disease, sex and age. Research processes are investigating the application of matching genetic makeup and drugs. Randomized Controlled Trials (RCTs) ask patients for voluntary blood samples which are analyzed for drug responsiveness which are then matched with genotype. The results are then used to create a database. By using this approach, there several benefits including: better diagnosis; improved selection of therapy for a patient; and awareness of potential adverse side effects in certain genotypes (King, 2010).
When patients are involved early in clinical trials, a better understanding of the physiology of disease being investigated is gained as opposed to using healthy volunteers. This ensures that progress towards providing personalized treatment is made. Participants used in trials are usually selected according to laid down criteria like medical history, sex, age, and others. In this process, the CRO carries out the research but the practice nurses and GPs are involved in the process of identifying patients who will participate in the study as the nurses in particular know the patients well. The nurses and GPs benefit by being part of a collaborative effort into clinical research and treatment innovation apart from the experience of working alongside other nurses and doctors from different fields of specialties (King, 2010).
Article Critique
The author’s main point is that the collaborative approach to clinical research results in the process of improving treatment options for the patients. I agree with this view because the author has been able to clearly articulate and defend his opinion. This article is intended for registered nurses as it provides more insight and advocates for the incorporation of both actual practice and clinical research into the role of the RN. The argument by King, (2010) is a logical one as it highlights how general practitioners and practice nurses can contribute to the success of clinical research and improve patient outcomes in terms of ensuring the efficacy and safety of drugs used. The article has argued this point by highlighting the various facets of clinical research. The RCTs are usually carried out by CROs who have been contracted by pharmaceutical companies to perform the research. In order to do this, the medics have to be involved in identifying the patients to be involved in the trials.
The GP is involved in reviewing the medical history of the patient and assessing their medical suitability for the studies. The practice nurses in hospitals are used to brief staff and coordinate activities with the CRO. In addition, the nurses have intimate knowledge of the patients and are able to identify which patients are able to stand the rigors of trials. The nurses also act as a source of support by being familiar faces during trials which puts the patients at ease.
The article is very well organized and easy to read and comprehend. The author has used clear language and the article itself presents a clear progression from the introduction of the subject to explaining the various factors involved in the author’s arguments. The author has also elaborated on any initials used in the article so as to promote understanding of the article and explained terms used. The impressive organization of the article can be seen in the article where the author takes time to explain personalized medicine and the mechanism of individual responses to drug therapy. The author then explains the role of CROs in the research process and the importance of using patients instead of healthy volunteers and continues to define the process of selecting patients for the RCTs. The article then elaborates on the roles of the GPs and practice nurses in this process and the importance of their contribution to clinical research in improving the treatment of the patients and safety of therapeutic drugs as el as the benefits of collaborative efforts to their practice. The article then concludes by summarizing the points made by the author.
A close inspection of the article reveals that there are no opposing points of view presented in the argument. I agree with the argument taken by the article and support the move towards research focusing on the responses of specific genotypes to drugs. Furthermore, the collaboration of the CROs, GPs and practice nurses should be encouraged.
Conclusion
This article is very relevant to medical and nursing practice as it emphasizes the importance of a shift of research towards personalized medicine that evaluates individual genotypic responses to therapy. It also highlights the roles of GPs and practice nurses in clinical research and the benefits of collaborative efforts by the different groups. I would recommend this article to registered nurses and GPs as it would enlighten them on how their participation in clinical research of this nature would improve patient outcomes.
Reference
King, M., (2010). Testing Drug Safety and Efficacy. Practice Nurse, 39(2), 31-33. Retrieved May 23, 2011, from ABI/INFORM Trade & Industry. (Document ID: 1968563591).
