Evaluation of the activity of CYP2C19 in Gujrati and Marwadi subjects living in Mumbai (Bombay)

BACKGROUND: Inherited differences in the metabolism and disposition of drugs, and genetic polymorphisms in the targets of drug therapy (e.g., receptors), can greatly influence efficacy and toxicity of medications. Marked interethnic differences in CYP2C19 (a member of the cytochrome P-450 enzyme superfamily catalyzing phase I drug metabolism) which affects the metabolism of a number of clinically important drugs have been documented. The present study evaluated the activity of CYP2C19 in normal, healthy Gujrati and Marwadi subjects by phenotyping (a western Indian population). METHODS: All subjects received 20 mg of omeprazole, which was followed by blood collection at 3 hrs to estimate the metabolic ratio of omeprazole to 5-hydroxyomeprazole. The analysis was done by HPLC. RESULTS: It was seen that 10.36% of this population were poor metabolizers(PM) whereas 89.63% were extensive metabolizers(EM). CONCLUSION: A genotyping evaluation would better help in identifying population specific genotypes and thus help individualize drug therapy

Writing an Abstract for a Research Manuscript: Providing an Honest, Succinct and Complete Summary

Abstract Abstract is a vital part of a research paper. Besides the title, it is the most widely read section of an article. The first impressions created by the abstract on editors and reviewers can have a great influence on the fate of the article. After its publication, a reader might decide to give the article a miss, if he finds the information provided in the abstract uninteresting, irrelevant or uninspiring. An abstract should, therefore, be packed with all important relevant information about the study, so that reviewers and readers understand the rationale of the study, are assured of adequacy of the methodology employed, are informed about the important findings and appreciate the reasonable conclusions stated in the abstract. Brevity, self-sufficiency, providing complete and accurate information in an unbiased manner are some of the important characteristics of a good abstract

Reporting ethical processes in two Indian journals

Background: In biomedical journals, authors are expected to report if the study was carried out in accordance with international and national ethical guidelines and inform readers if approval from ethics committee was obtained and if written informed consent was taken from the participant or legal guardian. Aims: To determine the proportion of research manuscripts in two pediatric journals published from India reporting on ethical clearance, obtaining of informed consent and/or assent. Settings and Design: Retrospective study for analysis of research articles published. Materials and Methods : Research articles published in the issues of Indian Pediatrics and Indian Journal of Pediatrics in 2006 were reviewed for reporting regarding ethical clearance, obtaining written informed consent from guardians or parents, and obtaining assent from research participants. Statistical Analysis Used: Descriptive statistics was used. The number of articles according to their types; the number of research designs employed according to their types; and the number of research studies mentioning ethical clearance, consent, and assent were expressed as percentages mentioning ethical clearance, consent and assent were expressed as percentages. Results: Of the 132 manuscripts reporting biomedical research, 39 (29.53%) reported having obtained approval from the ethics committee. Forty-six of the 98 (46.94%) manuscripts reporting on prospective studies indicated that informed consent was obtained from parents or lawful guardians. Neither ethical approval nor informed consent was mentioned in 45 (34.10%) published articles reporting prospective studies. A total of 54/98 (55.1%) studies enrolled children aged 7 years or more and hence were assessed for reporting of assent; eight (14.81%) reported that children′s assent was obtained. Only four (7.41%) eligible studies reported ethics committee′s approval, informed consent, as well as assent. Conclusions: A significant proportion of research articles published in the two pediatric journals did not provide information regarding ethical approval, written informed consent, and obtaining of assent

Regulatory requirements for clinical trials in India: What academicians need to know

The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Of these, research, though long and difficult, is extremely fulfilling. Academicians often carry out research that is based on observations in practice or in response to their patient's needs. These are called as “Investigator- initiated studies” and these may not have the funding support of the pharmaceutical industry. Hence, the investigator must make sure that he/she complies with the country's regulatory requirements. In the past decade, several changes have dotted the regulatory landscape in the country and have changed the way in which academic research is carried out. The present article outlines regulatory requirements for academic research giving their historical evolution, the key bodies in India that govern or oversee research, along with “must know” and “good to know” facets for the conduct of clinical research in the country

Valbenazine: Drug review

Valbenazine is the first drug approved by the US Food and Drug Administration for the treatment of adults with tardive dyskinesia (TD) on April 11, 2017. It acts as a reversible inhibitor of vesicular monoamine transporter 2. It is available orally with a starting dose of 40 mg once daily which can be increased after 1 week to the recommended dose of 80 mg. Clinical trials showed positive outcomes in Abnormal Involuntary Movement Scale and Clinical Global Impression - Global Improvement of TD score with respect to placebo. Valbenazine has an acceptable safety and tolerability profile, the most common side effect observed is somnolence. However, long-term study is lacking, and more data are required to establish its full benefits and concomitant risks which can be missed in the recent trials

Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India

Background: India continues to contribute disproportionately to the global burden of disease and public health research output from India is also known to be not commensurate with her healthcare needs. We carried out the present study to assess if clinical trials were in line with the health care needs of the country by auditing the clinical trials registry of India. Materials and Methods: All the clinical studies registered in CTRI between July 20, 2007 and December 31, 2015 were searched in the “Trial Search” section. The total number of studies, their phases of development, and therapeutic areas were assessed. Trials in each therapeutic area was compared with the disease burden (DALYs) in that area taken from Global Health Estimates [2014] Summary Tables of the WHO. The number of trials conducted per state in India was also compared with the population of that state [Census 2011]. Results: A total of 6474 studies were registered of which 3325 (51.4%) were clinical trials. The state of Maharashtra had the highest number trials [16.4%] followed by Karnataka ( 11.6%) and Tamil Nadu (10%). Populous states like Uttar Pradesh (5.3%) and Bihar (1.4%) had far fewer trials. The largest number of trials was in the area of cancer (16.4%), followed by diabetes (12.1%) and cardiovascular diseases (10.1%). Infectious and parasitic diseases had the highest DALYs (82,681) and ranked first in disease burden but accounted for only 5% of the total trials and ranked 7th according to number of trials. Cancer ranked first in the number of trials (16.4%), but ranked 6th based on DALYs. Conclusion: Clinical trials conducted in India are not in consonance with her health care needs. Strengthening the capacity for conducting trials in the populous states and the north-eastern part of the country is necessary to allow a more equitable selection of participants. The government should introduce policies to encourage new drug development in areas where needed the most