The relevance of preclinical studies to the development of clinical trials in humans Resources
Clinical research is a process that is rigorous in testing the efficacy and safety of candidate vaccines, therapies, and diagnostics. Only the candidates that have exceptionally performed through basic and pre-clinical research get approval for clinical trials in human beings. The essay will discuss the relevance of preclinical studies to the development of clinical trials in human resources (Field & Boat, 2010).
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Once a single compounding that is promising has been selected based on therapeutic discovery and basic research, pharmacological companies start the pre-clinical studies both in animals and in vitro to evaluate the potential toxicity and drug safety. These pre-clinical studies are also applied in assessing the potential effectiveness (Glaser, 2015)
Pre-clinical studies are also relevant to the development of clinical trials in human resources because the data and safety from the pre-clinical studies are vital in determining whether a drug will progress on to studies in human bodies. Moreover, pre-clinical studies also offer guidance to the researcher in designing phase one of the clinical trials. For instance, preclinical studies with the animal assist in determining the range of giving dosages of a test a drug for evaluation in phase one clinical trial (Field & Boat, 2010).
Pre-clinical studies are also relevant in that they help in identifying evaluation criteria for human safety, including signs and symptoms that should be closely monitored during the early stages of clinical trials (Glaser, 2015).
According to Field & Boat (2010), pre-clinical studies also generate the pharmacological profile of a drug under study that will be of significance long into the future of the drug. For instance, the researcher can use the drug profile from pre-clinical studies in developing the initial process of manufacturing and pharmaceutical formulation for use in human testing.
Genotype-Tissue Expression (GTEx)
The Genotype-Tissue Expression (GTEx) program is pursued by NIH to study the expression and regulation of the human gene in multiple tissues, providing insights that are valuable into the gene regulation mechanisms, and in the future perturbations that are diseases related (NIH, 2015).
The 2013 peer-reviewed article by GTEx Consortium addresses the program of Genotype-Tissue Expression (GTEx) in detail (GTEx Consortium, 2013). Moreover, there are other sources of information about this project available on the online newspaper articles and the internet such as the NIH Genotype-Tissue Expression (GTEx) brochure (NIH, 2015).
The Genotype-Tissue Expression (GTEx) program has several initiatives that NIH is pursuing to enhance both clinical research nationally and the program. Some of the initiatives include:
Novel Statistical Methods for Human Gene Expression Quantitative Trait Loci (eQTL) Analysis
This initiative solicits applications for developing statistical methods that are innovative in detecting genetic variation influence on tissue-specific gene regulation and expression. The goal of the initiative was to seek proposals of developing statistical methods to analyze appropriately the forthcoming complex set of data generated by the roadmap initiative of NIH entitled The Genotype-Tissue Expression (GTEx) project (Federal Grants, 2015). This initiative will influence the clinical trial stage of omics data and biospecimens where there would collection of normal biospecimens for the GTEx.
Laboratory, Data Analysis, and Coordinating Center (LDACC)
This initiative was established to seek a small business that has the capability of serving as a laboratory, data analysis, and center for coordination for their new pilot program of The Genotype-Tissue Expression (GTEx) (FBO, 2008). This initiative will be influence the GTEx Pilot Phase Data when analyzing and to Show How Differences in DNA Affect Disease Susceptibility and Gene Activity.
References
Federal Business Opportunities,. (2008). Laboratory, Data Analysis, and Coordinating Center (LDACC) – Federal Business Opportunities: Opportunities. Fbo.gov. Retrieved 25 May 2015, from https://www.fbo.gov/index?s=opportunity&mode=form&id=460c8226b5e734ef33a8f4aeb8a645a6&tab=core&_cview=0
Federal Grants,. (2015). Novel statistical methods for human gene expression quantitative trait loci eQTL analysis R01 – Federal Grant. Federalgrants.com. Retrieved 25 May 2015, from http://www.federalgrants.com/Novel-statistical-methods-for-human-gene-expression-quantitative-trait-loci-eQTL-analysis-R01-18028.html
Field, M., & Boat, T. (2010). Development of New Therapeutic Drugs and Biologics for Rare Diseases. National Academies Press (US). Retrieved from http://www.ncbi.nlm.nih.gov/books/NBK56179/
Glaser, V. (2015). Building Better Pipelines with ADME-Tox | GEN Magazine Articles | GEN. GEN. Retrieved 25 May 2015, from http://www.genengnews.com/gen-articles/building-better-pipelines-with-adme-tox/2111/
GTEx Consortium. (January 01, 2013). The Genotype-Tissue Expression (GTEx) project. Nature Genetics, 45, 6, 580-5.
NIH, (2015). Genotype-Tissue Expression (GTEx) program. NIH. Retrieved 25 May 2015, from http://commonfund.nih.gov/sites/default/files/GTEx_trifold_final_2012.pdf
NIH, (2015). Genotype-Tissue Expression (GTEx). Commonfund.nih.gov. Retrieved 25 May 2015, from http://commonfund.nih.gov/GTEx/index
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