Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 2, Issue 1, 2015

Clinical care is provided in a team approach because each member of the inter-professional team has valuable input to contribute to the care of patients. Clinical research is no different in that the construction of a research study is stronger if the right contributors are involved in the development stages. Having a peer-driven facilitative review process in place allows for proposed clinical research studies to be reviewed by all of these inter-professional colleagues that are focused on the professional significance, clinical significance, logistics, and protection of human subjects. Implementing this review process prior to submitting a research protocol to the Institutional Review Board (IRB) reduces the need to clarify study methods and revise supplemental study documents once they have been submitted to the IRB for approval.

Background: Intensive versus less stringent glucose control does not confer significant benefits in critical illness. However, insulin may have beneficial effects apart from its role in glucose homeostasis. Methods: Pilot, open-label, non-randomized study of glucose-insulin-potassium (GIK) infusion versus saline placebo in vasopressor dependent septic shock designed to test feasibility, safety, and preliminary efficacy. Inflammatory and endothelial biomarkers were measured before, during, and following treatment. Sidestream dark-field video microscopy and transthorasic echocardiograms were completed prior to and during treatment. Results: 9 patients were enrolled, 4 in the placebo and 5 in the GIK arm. Patients exhibited hyperglycemia at the start of infusion that normalized over time. Inflammatory biomarkers were non-significantly lower (p =0.05-0.25) in the interventional arm following treatment, while some endothelial biomarkers, most notably t-PAI (p = 0.02) were lower in the GIK arm. The microcirculatory measures non-significantly improved in the GIK arm compared to the placebo arm (p = 0.13-0.48). No differences in cardiac function nor vasopressor cessation were noted. Conclusion: GIK infusion is feasible but may cause hyperglycemia. There are potential beneficial effects on inflammation, endothelial activation, and microvasculature independent of macrovascular function. Further investigation of GIK and mechanisms driving these findings may be warranted.

The globalization of medical training has evolved in various ways including individual student migration across borders, academic institutional expansion abroad and governmental influence. The drive for revenue and the balance with teaching excellence is a struggle that medical institutions increasingly contend with today as they navigate in a global environment. In this review, we focus on this emerging data, specifically the economic, regulatory, and societal trends that are shaping the global landscape of medical training. Three important aspects are discussed including: (1) student migration (2) academic institutional expansion and (3) governmental influence in the global medical training realm.

In medical education, examples of global collaborations or partnerships are plentiful, as are the multifactorial motivations driving them. The outcome of transported educational models outside their original target environment can be difficult to predict, however, as contexts, cultures, norms, histories, traditions, processes, and practices coalesce among diverse groups. The resultant diversity can be considered a double-edged sword. Heterogeneous groups are shown to be better at creativity and innovation, while homogenous ones can more easily integrate within the group. In this article, some examples of the educational challenges and opportunities arising from the partnership between Duke University School of Medicine and the National University of Singapore (NUS), leading to the establishment of Duke-NUS Graduate Medical School are described. A decade since establishment of Duke-NUS, the ongoing balance of delicately overcoming integration challenges on the one hand, and optimizing innovation opportunities on the other, remains a formidable undertaking.

In spite of the after-effects of the global economic depression in the past few years, the direction of drug research in Finland is clear and positive. The industry is growing at a pace greater than the economic indices. Nordic collaboration has a significant influence on drug research and development in Finland. Recent statistics by the Finnish Medicines Agency (FIMEA), which supervises drug research and development indicates that the number of new clinical trials initiated last year remained consistent as the year before, approximately 122 commercial (sponsored) trial notifications and 30 noncommercial (non-industry sponsored) trials were recorded in 2013. Finland has a long tradition for vaccine trials in Finland and recently a significant thrust in oncology research, especially the development of targeted receptor-level drugs. Finland is a particularly suitable country for clinical drug research given the professional expertise of researchers, physicians and other health care personnel, irrespective of specialty. In addition, it is an equal opportunity for society whereby health care services are statutorily available to everyone.

Is your facility inspection ready at all times? Most organization are not ready at all times and, therefore find preparing for any type of FDA Inspection to be overwhelming. This paper provides guidance on how to prepare and how to respond to the FDA, specifically for larger clinical site inspections, Clinical Investigators, and drug manufacturer inspections. Also, tips are provided on how to take a proactive inspection readiness approach. These same inspection readiness strategies can be applied in a reduced manner by smaller organizations to help successfully manage regulatory inspections.

The Clinical Research industry has been in a state of dilemma with the changing regulatory scenario of India. It started with an upsurge of projects between 2005 and 2010 and then a steady decline in the last 5 years. The Government has reacted to this paradigm shift by instituting new regulations with more stringent measures to check compliance and conduct of the clinical research activities. The prime area of focus has been to increase the regulatory vigilance over investigators, sponsors, ethics committees and the institutions, thus ensuring protection of the subject rights, safety and wellbeing. We aim at emphasizing the need to shift the priority zone from ‘developing measures to cover subject rights and safety’ to directly ‘empowering subjects’ by making them aware of their rights and responsibilities. Our endeavor is to cover the current healthcare and clinical research status and the regulatory reforms in India; highlighting the ‘need of the hour’ that demands an urgent attention and swift engagement. We also propose ways to achieve this goal of spreading education and awareness regarding clinical research among the masses and visualizing the impact it would make on the nation’s health status. Considering the exponentially growing healthcare needs, the changing trends of the disease burden and the great potential of the nation for supporting clinical research activities, it is essential to map ways to capacitate the general population to contribute to the scientific developments and healthcare advancements without affecting their rights, safety and wellbeing. The new regulations would then act as an agonist to aid in making India a nation that delivers fair, scientific, ethical and good quality research.

Transient abnormal myelopoiesis is a unique syndrome characterized by leukocytosis with transient appearance of blast cells in the peripheral blood and bone marrow. Children with Down syndrome are at a higher risk of developing the disease as compared to normal children. Affected patients can be symptomatic or asymptomatic. We report a case of a male infant, born to a mother with history of infertility, who was found to have anemia, thrombocytopenia, and markerd leukocytosis with 80% immature cells and many blast cells in day two of life. Complete work up was done and the phenomenon of transient abnormal myelopoiesis was confirmed by immunophenotyping using flow cytometry. This is a self-limiting condition which requires supportive care and it resolves within few months. Patients are at higher risk of developing acute megakaryocytic leukemia after one year of age.