Academic journal article Marquette Intellectual Property Law Review

The Future of Clinical Trials: More Transparency and Pharmacogenomics

Academic journal article Marquette Intellectual Property Law Review

The Future of Clinical Trials: More Transparency and Pharmacogenomics

Article excerpt

The traditional approach to Pharma clinical trials is to treat the general population as a single group. This has resulted in a large number of failures and lost opportunities in bringing new cures to market. The problem with this approach is that most candidate drugs are not effective on 100% of the population. In fact, a good number of drugs that are considered safe on a majority of the population are known to have undesirable side-effects on a small proportion of the population. Hence, there is a need for designing clinical trials that would identify patient sub-population(s) who are likely to respond positively or negatively to a drug.

ClinicalTrials.gov is an open registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. There are public drug information databases such as Drugs AtFDA (7) and the Canadian DrugBank (8) including drug targets. Next-Generation Sequencing (NGS) technologies have made accurate sequencing of human genomes affordable. A good number of genome-wide association studies have been published in the recent literature associating specific genomic sequence variations with human diseases. NGs technologies offer a great opportunity to repurpose some of those drugs by enabling the identification of the molecular basis for the positive and negative effects of these drugs on patients. …

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