ABSTRACT
Background: This study was aimed to assess the knowledge regarding basic aspects of conduct of clinical trial and associated regulatory as well as ethical issues before and after and educational intervention in form of a workshop on Good Clinical Practice (GCP). Methods: One day workshop on “Good Clinical Practice” was planned which included important ethical and regulatory issues regarding clinical research. Various resource persons from industry and academia were chosen to address the workshop. Total 60 participants were enrolled for this one day workshop. Pre-workshop questionnaire of 15 questions were distributed before the actual topic started. Each participant had to fill the questionnaire form and return it within 15 minutes. Again at the end of workshop, post-workshop questionnaire containing the same questions were distributed and the participants were asked to fill the form. Sequence of questions was changed in post workshop questionnaire. Comparison between answers in pre and post workshop questionnaire was done. The primary outcome was knowledge, which was evaluated using the Wilcoxon signed rank test. Results: In Pre workshop, out of 60, total 28 (46.66%) participants had answered all 15 questions, while 30 (50%) participants had skipped to answer one question “Define GCP.” 2 out of 6 (3.33%) participants had not answered 4 and 5 questions out of 15, respectively. Total 45 out of 60 (75%) participants in post workshop answered all questions. All 15 (100%) questions were answered correctly in post workshop as compared to 11 (73.3%) questions in pre workshop. So, in post-workshop, there were significant (P <0.005) gains in knowledge regarding all good clinical practice questions. Conclusions: Good clinical practice knowledge improved markedly with a targeted education intervention in form of workshop. However, changes in behaviour and attitude were not studied by this questionnaire based study.
ABSTRACT
The way that research is communicated is changing rapidly. The internet has made it possible, a revolutionary way of providing access to the articles published in scholarly journals. The rising cost of subscription of scholarly journals, has seriously hampered the ability of libraries, research centers, and researchers to acquire publications necessary for research and knowledge enhancement. Open access publishing provides a way for addressing this challenge by offering a very cost-effective alternative to the traditional publishing model. Before the mid-1990s, most of the journals were available only on paper and accessible by subscription. By the end of the 20th century, most journals had moved their content to online platforms. Open access (OA) in simple meaning refers to unrestricted online access to the articles published in scholarly journals. There are two distinct ways articulated in the Budapest Open Access Initiative: (1) Articles directly provided by the journal publisher (also called “gold OA”), or (2) Indirectly by author self-archiving and/or being uploaded and made freely available somewhere else on the web (also called “green OA”).1 Green open access requires the author to deposit a peer-reviewed manuscript in an institutional or central repository such as PubMed Central. Both options increase the potential readership of any article.
ABSTRACT
Ivermectin is an antiparasitic drug with a broad spectrum of activity, high efficacy as well as a wide margin of safety. It belongs to the family of avermectins. It binds to glutamate-gated chloride iron channels, which are present in invertebrate nerve and muscle cells, and causes the paralysis and death of the parasite. Ivermectin is approved by the US Food and Drug Administration, and used worldwide to treat patients with onchocerciasis and strongyloidiasis. It is also used against a wide range of endoparasites (nematodes) and ectoparasites (insects, acarine) of animals and humans.
ABSTRACT
Background: F. racemosa is an indigenous plant having anti-secretory, anti-diabetic, anti-ulcer etc. properties. It is used widely in the ayurvedic medicines. Methods: The experimental models of wound and inflammation were used to assess the wound healing and anti-inflammatory properties of F. racemosa. The significance of differences was analyzed using students’ ‘t’ test. Results: In the strength of 10% local application it could apparently enhanced the process of healing. At the dose of 20 mg/100 gm intraperitoneally it could show inhibition of carageenan induced acute inflammation at 3rd, 5th and 7th hour and at the dose of 30 mg/100 gm intraperitoneally, formalin induced subacute inflammation was inhibited till 4th day. The results were found statistically significant. Conclusions: Aqueous extract of F. racemosa has got wound healing and anti-inflammatory activity. It is likely that the duration of action may be shorter.
ABSTRACT
Lorcaserin is a selective serotonin receptor (5-HT2C) agonist that recently received the U.S. Food and Drug Administration (FDA) approval for chronic weight management. The efficacy of this drug in reducing body weight and improving metabolic parameters of obese patients has been demonstrated in three phase-3 clinical trials. The available evidence indicates that this drug does not show heart valve abnormalities, and the treatment improves the risk factors for type 2 diabetes and cardiovascular diseases. However, the drug’s manufacturer will be required to conduct postmarketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Lorcaserin on the risk for major adverse cardiac events such as heart attack and stroke.
ABSTRACT
Background: The antineoplastic drugs are prescribed for the treatment of cancer, which is an important cause of mortality in India; therefore, a drug lag in the availability of antineoplastic drugs is a direct threat to life. The present study was undertaken to assess the drug lag for new antineoplastic agents in India compared with that in the United States (US) or European Union (EU). Methods: The new antineoplastic agents approved in the United States, European Union and India between 1999 and 2011 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. We assessed absolute and relative drug lag for new antineoplastic agents approved in the three regions. Results: Of the 70 new antineoplastic agents, 64 (91.42%) were approved in the United States, 54 (77.14%) in the European Union and 44 (62.85%) in India. The US was the first to approve 59 (84.28%) out of the 70 new antineoplastic agents, the EU was the first to approve 9 (12.85%) and India was the first to approve 2 (2.85%). The median approval lag for India (26.35 months) was higher as compared to the United States (0 month) and European Union (7.3 months). Conclusions: This study confirms that India’s drug lag in the case of new antineoplastic agents is higher as compared to the US and EU. Further detailed analyses are necessary to find the reasons and impacts of drug lag for antineoplastic agents in India.