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Which Choice Best Describes the Purpose of Most Pharmacogenomic Research

In this article, we’ll look at the role of the NIH in pharmacogenomic research and the progress that’s been made so far. The next section outlines the Common Rule of pharmacogenomic research and how it’s being used to study individual responses to drugs. Which choice best describes the purpose of most pharmacogenomic research?

Progress in pharmacogenomics research

There are several steps being taken to improve pharmacogenomics. A recent symposium organized by the Society for Experimental Biology and Medicine focused on the application of pharmacogenomics in drug development and regulatory agencies. It also discussed clinical implications of the findings. Its mission is to improve understanding of drug response and pharmacogenetics. To that end, it is developing a software tool that will help researchers standardize diplotype assignment.

Advances in pharmacogenomics research have revealed that genetic variation can affect the response to drugs. In addition to pharmacogenetic effects, genetic variations can also influence drug responses and toxicity. However, progress in clinical application of pharmacogenomics is slow. Most studies have been underpowered, with little replication in independent cohorts and insufficient mechanistic information to guide drug prescribing. Concerns about clinical utility remain a significant barrier to advancing the field.

Although pharmacogenomics is gaining momentum in clinical practice, it is not yet ready to be applied to individual patients. Pharmacogenomics is a complicated science, and inter-individual heterogeneity remains a key challenge in clinical decision-making. Increasingly, next-generation sequencing methods are being implemented in clinical trials, but the data derived from these studies is not yet ready for clinical application. The lack of powered trials further complicates the translation of genomic information. Because of the complexity of the subject, millions of rare variants are known to exist, but the functional consequences are unknown. Pharmacogenomics drug labels also reflect the inconsistency of the research.

Another challenge in pharmacogenomics research is the problem of multiple testing, which is associated with multiple-gene data. A common correction for multiple-testing is the Bonferroni correction, but this may be too conservative. Alternative approaches include permutation testing and false discovery rate control. These approaches estimate the expected proportion of false-positives. These approaches should be applied in studies that include more than one ethnic group.

Advances in pharmacogenomics research have made it possible to target drugs specifically to certain subgroups of patients. While there are broad disease classifications, many diseases are actually distinct and highly responsive to specific molecular subtypes. By targeting specific disease subtypes, researchers can improve drug efficacy and patient response. Molecular phenotyping involves the identification of proteins associated with a disease subtype. In addition to targeting disease subtypes, pharmacogenomics can optimize drug dosage, dose, and delivery.

Common Rule

A Common Rule for Pharmacogenomic Research must protect patients and research participants from unintended consequences and promote well-being in the broader society. The problem is that deep health inequalities exist, and people of color, Native Americans, and poor people in general are disproportionately affected by chronic diseases. Market forces cannot ensure that all people have access to good health care. Additionally, it is important to ensure adequate levels of informed consent and confidentiality for research participants.

Understanding genetic variation in drug metabolism is essential to improving the safety of drugs. A common example is codeine, which is metabolized to morphine in the body through an enzyme. However, a single genetic variant can cause fatalities in children. These genetic variants are challenging to study, because some are rare and common only in specific ethnic groups. The challenge is how to power studies to determine the optimal dose, as well as how to interpret the results.

Another ethical concern with pharmacogenomics is the issue of informed consent. A soldier who died of influenza in 1918, for instance, could not have given consent to his autopsy sample, because he did not know the specific genetic code of the virus at the time. His autopsy sample would have been needed to determine the identity of the disease-causing agent. Ultimately, the study of genetic markers in human tissues and blood will provide new knowledge about the human genome, which is critical to improving health care.

The Pharmacogenetics Working Group includes pharmaceutical companies that make drugs. Members include AstraZeneca, Aventis, Bristol-Myers-Squibb, Eli Lilly, GlaxSmithKline, and F Hoffmann-La Roche Ltd., as well as Schering-Plough. Despite the high cost of these studies, the results can help guide treatment decisions. In addition to improving drug safety, pharmacogenetic tests can also aid in the development of new drugs.

The cost of pharmacogenomic research may be prohibitively high. It is unlikely that the costs of research and development will be borne by individuals who can afford it. In a society with comprehensive national health insurance, the question of whether pharmacogenomic treatments will fit into overall health care budgets will remain. Limits must be established that do not shortchange the poor or those who live on the margins.

NIH role in pharmacogenomics research

The NIH’s role in promoting pharmacogenomics research is to support discoveries and investments that will lead to improved health and longevity. The agency is establishing research centers to promote pharmacogenomics research, which aims to tailor medical treatments to individual patients’ characteristics. NIH’s role in promoting pharmacogenomics research is to foster a collaborative culture that promotes research and collaborations, while fostering new knowledge of human genetics.

The NIH’s pharmacogenomics research includes three large center-grant projects that aim to improve precision medicine by translating genomic variations into therapeutic and adverse drug effects in patients. Two of the three PGRN projects are directed at developing enabling resources for pharmacogenomics and precision medicine. To this end, the network funds individual projects and research networks that develop innovative pharmacogenomics solutions.

Increasingly, the NIH is supporting multidisciplinary teams that use pharmacogenomics to optimize drug development and treatment. These teams can conduct prospective, empirically-based implementation trials to evaluate the impact of pharmacogenomics on clinical outcomes. For example, DPYD genotype-guided therapy has been shown to reduce the risk of fluoropyrimidine-associated toxicity. Furthermore, the 100,000 Genomes Project in England will evaluate the impact of prioritized gene-drug pairs.

While the NIH is supporting pharmacogenomics research, further steps must be taken to advance the field. Pharmacogenomics is an area of rapidly growing potential to improve healthcare outcomes. However, while advances have been made, the pace of translation of these findings into clinical practice has been slow. The NIH must expand its role in pharmacogenomics research to include broader healthcare fields.

Applicants must submit a detailed, itemized budget for each component. The budget should include funding for the initial period and the entire proposed period of support. This period is typically 5 years. Inflationary increases should not exceed the amount allowed for prior awards. However, it should be noted that individual institutes may limit increases for prior awards. Lastly, the Steering Committee should have a consensus on the scientific goals of the project.

The NIH has supported pharmacogenetics research by creating the Translational Pharmacogenetics Program. TPP was established in 2011 as an implementation science project that involved pharmacogenomics testing in various health care settings. The goal of the TPP was to harness the multidisciplinary expertise at participating sites to improve the clinical use of pharmacogenetics. In addition to facilitating the implementation of pharmacogenetics, the Translational Pharmacogenetics Program also investigated the obstacles in the development of clinical trials.

Using genomic information to study individual responses to drugs

Traditionally, drugs have been developed with the assumption that they work the same in all patients. This “one size fits all” approach has been challenged by genomic research, which has facilitated individualized approaches to drug treatment. For example, a particular drug may work better in certain patients and cause fewer side effects for others. Using genomic information to study individual responses to drugs will enable physicians to choose a drug based on a patient’s genetic makeup.

Genetic variations in gene expression are discovered through large-scale sequencing efforts, which identify genes involved in drug metabolism and action. However, pharmacogenomic variants must be validated and updated dosing guidelines developed. This research needs to be complemented by the development of quality-controlled software and fast approaches for evaluating individual responses to drugs. The potential benefits of these efforts are many, and this new approach has the potential to revolutionize drug development.

Using genomic information to study individual responses to medications is a promising way to improve healthcare. For example, a drug may be well tolerated in the general population, but may cause serious adverse effects in patients with a specific allele. For instance, abacavir, a common antiviral, is well tolerated by most patients, but is toxic in patients with a certain tumor profile and high HER2 protein.

Moreover, genomic information can help in identifying rare genetic variations that may influence drug absorption, metabolism, and action at the receptor level. This research has a variety of benefits, including increased efficacy and reduced cost. It also improves patient safety and reduces the risk of adverse drug reactions. Many adverse drug reactions are preventable and may be due to a genetic factor. In fact, genetic studies are the next step towards delivering better drugs.

The Mayo Clinic has launched an initiative called the Community Pharmacogenomics Network (CPPN) to educate community pharmacists on how to use genomic information to tailor drug therapy to the unique genetics of individual patients. The Mayo Clinic has already implemented alerts for 18 drug-gene pairs and informs 1.4 million patients annually. By using genomic information, physicians can better treat their patients, save money and time, and improve care.

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