The clinical trials toolbox has extensively grown, and researchers can now use biomarkers to increase predictive value for disease diagnosis. According to Potthoff et al (2015), clinical researchers have began to realize the positive impacts of “-omics” technology. The best example is genomic medicine that assists clinicians to understand the molecular basis of diseases during diagnosis as well as at treatment level. Genomic medicine is now gaining momentum across the clinical research field, both in healthy and diseased individuals (McCarthy, McLeod and Ginsburg, 2013). McCarthy, McLeod, and Ginsburg (2013), define genomic medicine as a modern trend in clinical research that involves the use of an individual’s genetic information as part of their clinical care. Although genomic medicine has brought about positive impacts on clinical care, the new trend presents a number of challenges on patient safety and on the field of clinical research as a whole. The purpose of this article is to address the future impact that genomic medicine will have on patient safety and on the quality of research findings. It reviews the major challenges and benefits that genomic medicine will present to the society in future as well as actions that should be taken to overcome those challenges.
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Various authors have documented the significance and challenge that genomic medicine present to the quality of research findings and on the field of clinical research as a whole. According to Manolio et al. (2013), genomic medicine has the potential to contribute positively to the clinical care, but the pace of implementing this new technology into the healthcare system has been very slow due to many challenges faced by clinical researchers. For instance, it takes relatively long time to come up with the correct genotype-phenotype associations for common complex diseases. This presents a big challenge for clinical researchers, especially when the desired results are needed urgently.
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In their article, McCarthy, McLeod, and Ginsburg (2013), review the major achievements in genome research over the past decade as well as the impacts of those findings on medicine. The best example is the use of next-generation sequencing in cancer diagnosis and in tracking outbreaks of infectious diseases. According to McCarthy, McLeod, and Ginsburg (2013), some of the challenge that face clinical research involving genomic medicine include difficulty in ascertaining the clinical validity and utility of genomic tests, regulatory and ethical issues surrounding the use of genomics on patients, and the limited uptake of genomic research findings by clinicians. According to Siwo, Williams, and Moore (2015), genomic medicine has brought about several opportunities for different nations, especially those that are extensively engaged in clinical research. For instance, genomic medicine presents great need for countries to invest in local education using real-world genetic data sets.
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Clinical research involving genomic medicine has resulted into several benefits in the healthcare industry. One of the areas where genomic medicine is largely applied is in tumor-based screening. In the United States, several cancer centers use genomic medicine techniques in tumor genotyping for cancers such as melanoma, lung cancer, and breast cancer. Genomic medicine research has also promoted family-history directed decision support. Information on self-reported family history is largely beneficial in risk assessment for patients with renowned clinical utility and validity. Family history is always easy to collect using electronic data collection tools. However, it is unnecessary to incorporate the collected information into independent electronic medical record. Genomic medicine allows clinicians to integrate patient-centered information into existing medical records to generate a pedigree and tabular family history (Manolio et al., 2013).
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According to Manolio et al. (2013), genomic medicine has also facilitated the use of pharmacogenomics which allows clinicians to make appropriate decisions for patients who are genetically unable to activate prodrugs. Many health care organizations have now implemented programs to conduct genotyping in patients who are likely to obtain medications that require genetically-based dosing. Tests related to clinical pharmacogenomics are now used in large scale by many research networks around the world. Another benefit that genomic medicine has brought in the field of clinical research as a whole and in patient care is promotion of diagnostic genome sequencing. With the help of genomic medicine research, whole-genome sequencing is currently used to identify the genetic causes of unknown health conditions, especially those presenting in childhood (McCarthy, McLeod and Ginsburg, 2013). The four benefits of genomic medicine research described above demonstrate that the new technology has transformed the field of clinical research and the field of health care (Manolio et al., 2013).
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Several challenges have been encountered in launching clinical research project involving genomic medicine. The biggest challenge is reluctance of clinicians and health care organizations to take up genomic research findings to improve patient care. Clinicians do not appreciate genomic research findings because they lack evidence of clinical validity and utility. Even for genomic findings with proven validity and utility, many healthcare institutions are still unable to implement them into their health care systems. In order to overcome this challenge, modern populations should be trained on the benefits of implementing genomic research findings in health care for promotion of patients’ health (Manolio et al., 2013).
Many health care institutions are unable to engage in clinical research involving genomic medicine due to cost concerns. As Manolio et al. (2013), point out, many institutions will soon be compelled to incorporate dense genotyping technologies into clinical care which will require them to use a lot of money to obtain the necessary genetic information with limited evidence. This challenge can be overcome by looking for funds from relevant funding organizations before starting genomic medicine projects, and by aligning evidentiary threshold with the genomic information that is being intended for use. Another challenge facing genomic medicine research and its implementation is reliance on expert panels to evaluate available evidence for genomic medicine information. These panels tend to work in isolation and come up with conclusions that do not yield valuable contributions to the field of healthcare. The best way to overcome this challenge is to harness the collective knowledge of expert panels in order to ensure that the correct genomic information is collected and evaluated (Manolio et al., 2013).
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Genomic medicine now forms a very important part of clinical research in the modern world. Health care institutions should be prepared to integrate genomic medicine into their systems because the new technology will largely be used to provide care to patients in the near future. The government should expand certification of genomic laboratories and technologies and ensure that all genomic medicine research is conducted with great ethical adherence. Additionally, appropriate professional organizations such as the Association of Molecular Pathologists should be involved in developing evidentiary standards to support genomic research findings (Siwo, Williams and Moore, 2015).
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