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Despite regenerative medicine (RM) being one of the hottest topics in biotechnology for the past 3 decades, it is generally acknowledged that the field's performance at the bedside has been somewhat disappointing. This may be linked to the novelty of these technologies and their disruptive nature, which has brought an increasing level of complexity to translation. Therefore, we look at how the historical development of the RM field has changed the translational strategy. Specifically, we explore how the pursuit of such novel regenerative therapies has changed the way experts aim to translate their ideas into clinical applications, and then identify areas that need to be corrected or reinforced in order for these therapies to eventually be incorporated into the standard-of-care. This is then linked to a discussion of the preclinical and postclinical challenges remaining today, which offer insights that can contribute to the future progression of RM., (© 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.)

Background: Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information., Materials and Methods: To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch-Kincaid Grade Level, Fog Scale, SMOG Index, Coleman-Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level., Results: Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001)., Conclusion: Invasive procedure consent forms have readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions., (© 2015 Wiley Periodicals, Inc.)

Researcher-initiated biobanks based at academic institutions contribute valuable biomarker and translational research advances to medicine. With many legacy banks once supported by federal funding, reductions in fiscal support threaten the future of existing and new biobanks. When the Brain Bank at Duke University's Bryan Alzheimer's Disease Center (ADRC) faced a funding crisis, a collaborative, multidisciplinary team embarked on a 2-year biobank sustainability project utilizing a comprehensive business strategy, dedicated project management, and a systems approach involving many Duke University entities. By synthesizing and applying existing knowledge, Duke Translational Medicine Institute created and launched a business model that can be adjusted and applied to legacy and start-up academic biobanks. This model provides a path to identify new funding mechanisms, while also emphasizing improved communication, business development, and a focus on collaborating with industry to improve access to biospecimens. Benchmarks for short-term Brain Bank stabilization have been successfully attained, and the evaluation of long-term sustainability metrics is ongoing., (© 2015 Wiley Periodicals, Inc.)

The formation of the National Center for Advancing Translational Sciences (NCATS) brings new promise for moving basic science discoveries to clinical practice, ultimately improving the health of the nation. The Clinical and Translational Science Award (CTSA) sites, now housed with NCATS, are organized and prepared to support in this endeavor. The CTSAs provide a foundation for capitalizing on such promise through provision of a disease-agnostic infrastructure devoted to clinical and translational (C&T) science, maintenance of training programs designed for C&T investigators of the future, by incentivizing institutional reorganization and by cultivating institutional support., (© 2012 Wiley Periodicals, Inc.)

This commentary is germane for clinical and translational researchers. Basic scientists may face different obstacles to developing their research careers. Over the past several years, the federal government has seen reductions in funding for extramural research. It seems that under the adverse economic forecasts, things are going to get worse. It might seem logical for the federal government to stretch whatever limited resources exist, by asking the institutions to cost-share greater fractions of the actual research costs, and as an incentive, avoid the imposition of unfunded mandates. But alas, although well intended, there have been expensive requirements imposed by the government, making it difficult for investigators and institutions to adequately fund and conduct their research and for scientific journals to maintain paying subscribers. Five prominent and costly changes, which are the focus of this commentary are (1) HIPAA, (2) http://ClinicalTrials.Gov, (3) Clinical and Translational Science Awards, (4) Upcoming rule changes for IRBs, and (5) PubMedCentral, each of which will be discussed in the ensuing paragraphs., (© 2012 Wiley Periodicals, Inc.)

Research translation typically includes translation from basic science into clinical research and from clinical research into everyday clinical practice. In this essay, we propose a greater emphasis on applying research findings, both basic and clinical, into effective public policies that promote health. Research can have important influences on policy by providing a scholarly basis for action research, and translation science units within academic health centers are in powerful positions to build bridges between the research and policy making communities to promote the development of evidence based policy. The results will benefit the researcher and the decision maker, as well as the research itself.