SummaryEmollients can perform an important role in the treatment of a number of dermatological conditions. Currently, the use of emollient therapy in the UK is supported only by limited guidelines and a best-practice statement, although guidelines do exist for specific conditions such as childhood eczema. To address this need, a group of clinical professionals covering acute community-care settings and medicines management met to review current data and practice. Their aim was to support other professionals in their approach to the use of emollient therapies in dry-skin conditions.

Background The clinical trials community has a never-ending search for dependable and reliable ways to improve clinical research. This exploration has led to considerable interest in adaptive clinical trial designs, which provide the flexibility to adjust trial characteristics on the basis of data reviewed at interim stages. Statisticians and clinical investigators have proposed or implemented a wide variety of adaptations in clinical trials, but specific approaches have met with differing levels of support. Within industry, investigators are actively exploring the benefits and pitfalls associated with adaptive designs (ADs). For example, a Drug Information Association (DIA) working group on ADs has engaged regulatory agencies in discussions. Many researchers working on publicly funded clinical trials, however, are not yet fully engaged in this discussion. We organized the Scientific Advances in Adaptive Clinical Trial Designs Workshop to begin a conversation about using ADs in publicly funded research. Held in November of 2009, the 1½-day workshop brought together representatives from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the European Medicines Agency (EMA), the pharmaceutical industry, nonprofit foundations, the patient advocacy community, and academia. The workshop offered a forum for participants to address issues of ADs that arise at the planning, designing, and execution stages of clinical trials, and to hear the perspectives of influential members of the clinical trials community. The participants also set forth recommendations for guiding action to promote the appropriate use of ADs. These recommendations have since been presented, discussed, and vetted in a number of venues including the University of Pennsylvania Conference on Statistical Issues in Clinical Trials and the Society for Clinical Trials annual meeting. Purpose To provide a brief overview of ADs, describe the rationale behind conducting the workshop, and summarize the main recommendations that were produced as a result of this workshop. Conclusions There is a growing interest in the use of adaptive clinical trial designs. However, a number of logistical barriers need to be addressed in order to obtain the potential advantages of an AD. Currently, the pharmaceutical industry is well ahead of academic trialists with respect to addressing these barriers. Academic trialists will need to address important issues such as education, infrastructure, modifications to existing funding models, and the impact on Data and Safety Monitoring Boards (DSMB) in order to achieve the possible benefits of adaptive clinical trial designs.

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Objectives: The conference objectives included educating patients and advocates about clinical trials, educating the clinical research community about patient perspectives on participating in clinical trial design, and identifying strategies to increase participation in clinical trial design for neurological disorders. Design: Observations were noted during a 1-day conference attended by patients, patient advocates, clinical trial staff, and investigators. The conference offered didactic sessions, small, and large group discussions. Participants: Conference participants were patients, patient advocates, clinical trial staff, students, and investigators interested in engaging patients in clinical trial design for neurological disorders. Measures: Conference participants were asked to consider lessons learned that could increase patient engagement in clinical trial design. Results: We found that there is growing interest in including patients in the design of clinical trials for neurological disorders. Several themes emerged on how to move forward: networking; the multifaceted roles of advocates in research; training and education; creating patient-researcher partnerships; and clinical trials regulation issues. Conclusions: The conference provided a forum for dialogue regarding stakeholder engagement in the design of clinical trials for neurological disorders. This experience provides a template for replication and dissemination of this conference and informs next steps to accelerate the pathway from dialogue to action. Clin Trans Sci 2015; Volume 8: 776-778

Several studies have indicated that the combination of metronidazole and spiramycin is synergistic against anaerobic bacteria and may be effective against oral infections. The present study sought to determine the efficacy and safety of a commercial preparation of these two antibiotics (Rodogyl) when used adjunctively in the treatment of advanced periodontal disease. In a double-blind parallel randomized trial, 56 patients (mean age = 44 years) with advanced periodontitis (50 of whom completed the study) were assigned to either the Rodogyl or placebo group. Both groups were thoroughly scaled and root planned for approximately 6 hours, with one group receiving Rodogyl for 2 weeks and the other a placebo. No other therapy was received during the study period. Two sites in each patient with probing depths of at least 7 mm were selected for study. Plaque level (P1I), gingival inflammation (GI), probing depth (PD), and attachment level (AL) were measured at baseline, 14 days, 1 month, and then at monthly intervals up to 6 months. Subgingival bacteria were monitored with dark-field microscopy. The development of resistant bacteria, as well as side effects to the medications, was also monitored. The Rodogyl group exhibited a greater gain in AL (0.67 mm) from the 2-month interval until the end of the study. Although this difference was statistically significant (P less than 0.05), it was not necessarily of biologic significance. There was a significantly greater decline in the proportion of spirochetes in the Rodogyl group at the 14-day interval, and this difference remained significant (P less than 0.05) at all study intervals. No difference in the proportion of motile organisms was observed.(ABSTRACT TRUNCATED AT 250 WORDS)

The case of a 3-week-old infant with Coxsackie B3 meningoencephalitis is discussed. Hypoglycorrhachia and neutrophils in the cerebrospinal fluid characterized the first ten days of her illness. Coxsackie B3 should be added to the list of enteroviruses that can cause hypoglycorrhachia during infections of the central nervous system in children.