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Plants are the integral part of the traditional indigenous healthcare system and are becoming concrete source of new drug discovery, evident by the increasing numbers of modern drugs derived from the phytochemicals. Emblica officinalis Gaertn. or Phyllanthus emblica Linn (family Phyllanthaceae) has been explained extensively and well documented for its therapeutic efficacies in indigenous system of medicine, in India. Every part of this plant possesses high medicinal value but fruits are the most valuable part in folklore and therapeutic uses. The polyphenols found in E.officinalis , especially tannins and flavonoids are key responsible elements for major bioactivities. E.officinalis is one of the major component in various health tonics, also exerts synergistic effects in enhancing the medicinal efficacy. E.officinalis exhibits broad spectrum of pharmacological activities through various mode of actions including antioxidant, anticancer, immunomodulator, anti-inflammatory, cyto-protective properties etc. Medical practitioners across the globe also advocated its application in managing diabetes, dyslipidemia, obesity, several types of cancer, liver disorders, arthritis, gingivitis, wound healing etc. The present review analysed and summarized the pharmacological actions, experimental studies and clinical trials of E. officinalis with emphasis on its immuno-enhancer, antiinflammatory and anticancer activities and possible mechanism of actions to provide future directions in translating these findings clinically. [ABSTRACT FROM AUTHOR]

OBJECTIVE To determine attitudes of small animal practitioners toward veterinary clinical trials and variables influencing their likelihood of participating in such trials. DESIGN Cross-sectional survey. SAMPLE Small animal practitioners with membership in 1 of 2 online veterinary communities (n = 163 and 652). PROCEDURES An online survey was developed for each of 2 veterinary communities, and invitations to participate were sent via email. Each survey included questions designed to collect information on the respondents' willingness to enroll their patients in clinical trials and to recommend participation to clients for their pets. RESULTS More than 80% of respondents to each survey indicated that they spend no time in clinical research. A high proportion of respondents were likely or extremely likely to recommend clinical trial participation to clients for their pets when those trials involved treatments licensed in other countries, novel treatments, respected investigators, or sponsoring by academic institutions, among other reasons. Reasons for not recommending participation included distance, time restrictions, and lack of awareness of ongoing clinical trials; 28% of respondents indicated that they did not usually learn about such clinical trials. Most respondents (79% to 92%) rated their recommendation of a trial as important to their client's willingness to participate. CONCLUSIONS AND CLINICAL RELEVANCE Participation in veterinary clinical trials by small animal practitioners and their clients and patients appeared low. Efforts should be increased to raise practitioner awareness of clinical trials for which patients might qualify. Specific elements of trial design were identified that could be modified to increase participation. [ABSTRACT FROM AUTHOR]

During ATMOSPHERE, a trial comparing aliskiren, enalapril, or both for heart failure, two other trials suggested harm from aliskiren in patients with diabetes, and regulators stopped aliskiren in such patients in ATMOSPHERE. The data monitoring committee suggests that regulators should trust the DMC to ensure patient safety in a clinical trial. The trial sponsor (Novartis) and the regulatory agencies have responded in letters to the editor. [ABSTRACT FROM AUTHOR]

This study aimed to investigate the efficacy of low-level laser irradiation when applied just before placement of resin composite on reducing postoperative sensitivity of class V lesions. In this randomized clinical trial, 31 patients with 62 class V cavities were included (two teeth in each participant). The teeth were randomly assigned into laser and placebo groups. After cavity preparation, the teeth in the experimental group were subjected to irradiation from a low-power red laser (630 nm, 28 mW, continuous wave, 60 s, 1.68 J), which was applied for 1 min on the axial wall of the cavity. In the control group, the same procedure was performed but with laser simulation. Then, a self-etch adhesive was applied and the cavities were restored with a microhybrid resin composite. Before treatment and on days 1, 14, and 30 after treatment, tooth sensitivity to a cold stimulus was recorded using a visual analogue scale. Data were analyzed by Friedman and Wilcoxon signed-rank tests ( p < 0.05). Pain scores after restorative procedures were significantly lower in the laser group compared to the placebo application ( p < 0.05). Although both groups experienced a significant improvement in pain and discomfort throughout the follow-up periods ( p < 0.001), the changes in visual analogue scale (VAS) scores between baseline and each follow-up examination were significantly greater in the laser than the placebo group ( p < 0.05). Low-level laser therapy (LLLT) before placement of resin composite could be suggested as a suitable approach to reduce postoperative sensitivity in class V restorations. [ABSTRACT FROM AUTHOR]

There is growing interest in the application of molecular profiling, including sequencing, genotyping, and/or mRNA expression profiling, to the analysis of patient tumors with the objective of applying these data to inform therapeutic choices for patients with advanced cancers. Multiple clinical trials that are attempting to validate this personalized or precision medicine approach are in various stages of development and execution. Although preliminary data from some of these efforts have fueled excitement about the value and utility of these studies, their execution has also provoked many questions about the best way to approach complicating factors such as tumor heterogeneity and the choice of which genetic mutations to target. This commentary highlights some of the challenges confronting the clinical application of molecular tumor profiling and the various trial designs being utilized to address these challenges. Randomized trials that rigorously test patient response to molecularly targeted agents assigned based on the presence of a defined set of mutations in putative cancer-driving pathways are required to address some of the current challenges and to identify patients likely to benefit from this approach. [ABSTRACT FROM AUTHOR]

Low income countries like Ethiopia are underrepresented in clinical research. As a major public commitment to clinical research, Ethiopia celebrated the International Clinical Trial Day (ICTD) for the first time on 20 May 2014 under the auspices of Addis Ababa University. The motto for the day was 'Clinical Trials for Excellence in Patient Care'. The celebration offered an opportunity to inform academic staff, researchers, students and the leadership about clinical trials being conducted and to discuss the future of clinical trials in the country. Although clear challenges to the conduct of trials abound, clinical trials registered from Ethiopia in trial registration databases is increasing. Cross-country collaborations, international funding support, motivation of academic staff to conduct clinical trials and the commitment and engagement of the leadership in research are all improving. The overall impact of clinical trials is also encouraging. For example, some of the trials conducted in Ethiopia have informed treatment guidelines. However, administrative capacity, research infrastructure as well as financial support remain weak. There is a need for enhanced university-industry linkage and translation of research findings into locally relevant evidence. Ethiopia, as well as the whole of Africa, has an unparalleled opportunity to lead the way in clinical trials, given its prospect of development and the need to have locally relevant evidence for its growing population. In this commentary we reflect on the celebration of ICTD, the status and opportunities for conducting clinical trials and the way forward for facilitating clinical trials in Ethiopia and Africa. [ABSTRACT FROM AUTHOR]

The article provides information on dependency of successful multicenter clinical trials on principal investigator (PI). Topics discussed include involvement of physicians in logistics of production, national and international recognition, interruption in clinical workflow, and self-interested documentation.

Background: In order to a drug be approved it must assure its secure and efficacy, by preclinic and clinic trials; the last ones involve human models with the aim to indentify, among others, adverse drug reactions. One important limitation of these trials is its population size, compared with population size that actually is going to take the drug. Objectives: To detect, notify, register and assess adverse drug reactions in order to determine the frequency, some predisposing factors and most frequent therapeutic groups as causal of adverse reactions. Material and method: A retrospective study was performed usin pharmacovigilance and collected relevant information in order to identify major therapeutic groups, as well as predisposing factors (gender and age) in patients attending to Hospital Regional Lic. Adolfo Lopez Mateos, Mexico City. Codification of adverse reactions was made according to suggested by National Center of Pharmacovigilance, consisting on five fields. Notifications were compiled to extract information of therapeutic groups, number of cases of adverse reactions and drugs causing them. Results: Main therapeutics groups were antibiotics, antiretroviral and analgesic drugs. Male gender showed the highest number of adverse drug reactions; mean age of studied population was of 30-39 years. Conclusions: By assessing notifications of adverse reactions to drugs the main therapeutic groups causing these reactions were detected: antibiotic, antirretroviral and analgesic; thus, this study contributes to health professionals and patients to control properly the administration of drugs. [ABSTRACT FROM AUTHOR]

The article offers information on several plans to increase the speed in disease treatments from clinical trials to patient utilization. Among the plans include the development of chips that mimics the human tissues, improvement of data management tools, and efficient translational research. Also mentioned are the causes of the prolonged pre-implementation periods such as the occurrence of uncontrollable events, underestimation on the duration of project completion, and lack of coordination.

: Jonathan Cook and colleagues systematically reviewed the literature for methods of determining the target difference for use in calculating the necessary sample size for clinical trials, and discuss which methods are best for various types of trials. Please see later in the article for the Editors' Summary [ABSTRACT FROM AUTHOR]

The author comments on the lack of oversight of randomized clinical trials which has occasionally led to investigator misconduct. Topics covered include the failure to standardize rules for the conduct of post-marketing trials, a case of data fabrication in Japan disclosed by a whistleblower in an investigator-driven clinical trial for an antihypertensive blockbuster drug, and the need for more transparent, and well-conducted post-marketing clinical trials.

The article presents a study on the potential effect of iron supplementation on the absorption of copper and zinc in breastfed infants. It highlights the recruitment of healthy breastfed term infants for a randomized clinical trial wherein zinc and copper absorption and stable isotopes was measured and monitored. It also emphasizes that age related in breastfed infants does not affect the absorption, as being depicted in the study.

This is a response to Jickling and Sharp's paper discussing the near-complete failure of clinical trials for stroke interventions. While they propose a paradigm shift in the way preclinical research is conducted, I propose that it is clinical trial design that needs an overhaul. Clinical trials could be designed to reduce variance, prevent data entry errors, and encompass less ambitious enrollment criteria limited to fewer centers which have demonstrated expertise in the treatment of stroke (and TBI). Statistical fundamentalism is another soluble problem: clinical trial designs tend to address what is medically significant as opposed to what is primarily statistically significant. Adaptive Design is an alternative to current protocols that needs urgent consideration if we are to get through the Valley of Death between bench and bedside. Maybe it is time to change the clinical trial paradigm to adopt the precise modeling used in good laboratory research rather than asking scientists to give up well-established procedures for producing reliable and reproducible results. [ABSTRACT FROM AUTHOR]

The article discusses the concept of blockchain in applied clinical trials for development of a interoperable, and auditable platform that enables investigational product (IP) to be tracked from point of manufacture to consumed by the patient. Topics include the partnership of Hu-manity.co with International Business Machines (IBM) to use blockchain platform as its global consent ledger, and commercial use of personal information.

The authors reflect on the importance of having a standardized collection of clinical trial results such as the CoRe Outcomes in WomeN's Health (CROWN) Initiative facilitated by Khalid Khan, editor-in-chief of the "British Journal of Obstetrics and Gynaecology." Topics discussed include the International Urogynecology Association (IUGA)-International Continence Society (ICS) standardization of reporting outcomes and the PICO process to be followed for every clinical study.

The authors examine the rapid expansion of clinical trial activity in emerging markets and concerns about the quality of data generated and the relevance of products being tested to local health care priorities. They note several high-profile cases of research misconduct in Asia, Africa and Latin America and accusations of widespread bribery by pharmaceutical companies. They point out the need for effective and affordable strategies to detect serious research misconduct.

The article reports on the aspects of clinical trials in the pharmaceutical industries. It states that clinical trials are important for drug's approval and as basis for the evidence of efficacy and safety. Also mentioned that clinical trials are affected by several factors such as the treatments, attitudes, and the cultures of different countries that are unique in several aspects.

The article offers the author's insights about rebranding risk-based monitoring (RBM). The author suggests that most organizations engaged in clinical research have been sitting on the edge of the risk-based monitoring pool. He also tackles the declining trend in the percentage of source document verification (SDV) coverage measured industry-wide.