The first paper comes from the journal Pharmacogenomics (Clinical pharmacogenetics: how do we ensure a favorable future for patients?) and it discusses the factors that have impeded the implementation of pharmacogenomic (PGx) testing into routine clinical care. Randomized clinical trials (RCT) are the current gold-standard for clinical research for new drug approvals, but the nature of PGx studies is ill-suited to the RCT format. The authors propose alternatives to RCTs such as demonstration of non-inferiority to standard of care, N-of-1 trials for individuals or “hybrid effectiveness-implementation” clinical trials (trials that blend design components investigating clinical effectiveness with implementation research). They also emphasize that implementation of PGx data would require comprehensive, pre-emptive testing, population specific PGx considerations, and storage of results in electronic medical records (EMR) with adequate clinical decision support (CDS) tools. Finally, they make the case for testing for genetic variants with robust evidence of a PGx association, and specifically cite the Clinical Pharmacogenenomics Implementation Consortium (CPIC) as a “promising place to start” in selecting PGx genes to test as well as PharmGKB as a resource for information on gene-drug PGx associations.
The second paper, authored by the International Society for Biocuration (Biocuration: Distilling data into knowledge), comes from the journal PLoS Biology. It explains the specific role that biocurators play within teams that manage biological information resources and databases. Beginning with the premise that data is an asset whose value increases each time it is shared, the authors argue that biocurators maximize value by assuring the “accuracy, comprehensiveness, integration, accessibility, and reuse” of data through the process of extracting knowledge (such as data) from unstructured forms (usually publications) into structured and machine readable forms to enhance its usability and sharing. The authors note that there is encouraging development with regard to data reporting tools, an increase in demand and support for data standards and a growth in the use of biocuration tools by researchers, and all of these are expected to facilitate data curation, data sharing and ultimately, scientific progress.
