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MBBS students lack training in research ethics which is crucial when they enter clinical practice and venture into clinical research in future. This study was planned to implement an educational module to build concepts in research ethics.
To assess the change in the knowledge and attitude of medical students towards research ethics.
The study was initiated after obtaining institutional ethics committee approval. It was an interventional study, conducted on 2nd MBBS students (N=130) subjected to an educational program which comprised of three modules viz., theme lectures, educational visits and small group case based learning. A prevalidated questionnaire(35 items), was administered at baseline and at the end of 3 modules, to assess the change in the knowledge gained and in the attitude towards ethics in animal and human research. Feedback was obtained from students and faculty to assess the outcome of this program.
On analyzing the knowledge gained post intervention in 130 students, it was observed that in the post test for the items on ethics committee- need and composition, principles of research ethics was answered correctly by more number of students, which was statistically significant. The statistically significant positive change was observed for attitude of these students towards both animal and human research ethics. Case based discussions provided better understanding of ethical practices and its importance in conducting research as responded by majority students and faculty.
Educational program on research ethics enhanced learning and brought about the positive attitudinal change. Majority students' and faculty appreciated the program and considered it as relevant for undergraduate training.
Educational program on research ethics enhanced learning and brought about the positive attitudinal change. Majority students' and faculty appreciated the program and considered it as relevant for undergraduate training.
Hepatitis B virus infection is a major public health problem in India, and all health-care workers (HCWs) need to be immunized to prevent occupational exposure. This study was done to find the hepatitis B vaccination rates, immune response, and predictors of titer <10 mIU/ml among students and HCWs of a tertiary care institution in the state of Kerala.
This was a cross-sectional study conducted in the Department of Microbiology, Government TD Medical College, Alappuzha, Kerala, India, for a period of 1½ years between January 1, 2016, and June 30, 2017. Vaccination rates were collected through a screening proforma. Of the 1321 participants who filled the screening proforma, 5 ml of blood was collected aseptically from 579 participants who were fully vaccinated (all the three doses of vaccine) and stored at -20°C until antibody to hepatitis B surface antigen (anti-HBs) assay was done using Microlisa (Biorad). Data were analyzed using SPSS for Windows, version 16.0. (SPSS Inc., Chicago, IL, USA) (trial ve(OR 2.94, 95% CI 1.42-6.07), and body mass index (BMI) >25 (OR 2.51, 95% CI 1.44-3.39) were associated with nonprotective titer.
More than a quarter of the study population who were at high risk of exposure were unvaccinated or partially vaccinated. Even after taking the full course of hepatitis B vaccine, 12.3% had titer <10 mIU/ml. Nonprotective titer was found to be associated with age >35 years, last dose taken >10 years ago, no boosters/revaccination, and BMI ≥25.
10 years ago, no boosters/revaccination, and BMI ≥25.
Psychiatric emergencies (PEs) are defined as acute disturbances of thought, mood, behavior, or social relationships requiring immediate interventions. The common emergency psychiatrics are attempted suicide, severe anxiety, schizophrenia, acute psychosis, substance abuse, acute panic attacks, drug toxicities, and extrapyramidal reactions. Emergency physicians in the general hospital may face the challenge of assessing and managing patients in PEs. This study was conducted to evaluate the clinical pattern and drug use pattern for PEs at a tertiary care hospital.
This was a cross-sectional, observational study where patients presenting to emergency medical services of a tertiary care hospital were recruited after approval from Institutional Ethics Committee and written informed consent. Demographic details, diagnosis, medication details, cost of the treatment, and adherence to guidelines in the management of emergency psychiatric conditions were assessed using a validated questionnaire. Descriptive statistics was applied to analyze the data.
In 110 patients, a total number of drugs prescribed were 463 (mean 4.21 drugs/prescription). The most commonly used psychotropic drug in emergency setting was found to be risperidone (19.39%), followed by lorazepam (13.60%) and clonazepam (4.28%). The most common diagnoses were substance abuse (32.72%) and schizophrenia (21.81%). About 74.5% of the physicians prescribed drugs abiding by the standard guidelines. The average total cost incurred by patients was about Rs. 366.
The most commonly used drugs in emergency treatment found in this study are risperidone, followed by lorazepam and haloperidol.
The most commonly used drugs in emergency treatment found in this study are risperidone, followed by lorazepam and haloperidol.
The Investigational New Drug (IND) committee advises the Drug Controller General of India on matters pertaining to clinical trials (CTs) of IND for clinical development. An audit of the minutes of this committee's meetings would shed light on the drug discovery in India.
Minutes of the IND committee meetings available in the public domain (2-year period) were evaluated. The applications which were postponed were excluded from the study. Outcome measures were therapeutic areas of IND, purpose of the applications, status of registration with the CT Registry of India (CTRI), and the innovator country.
The minutes of
= 7 meetings were available in the public domain for the period January 2017-December 2018 with
= 45 agenda items. One agenda item was excluded, and
= 44 agenda items were finally analyzed. The total number of therapeutic agents discussed was
= 29, of which
= 7/29 and
= 6/29 belonged to infectious diseases (ID) and oncology, respectively. The total number of purposes of these applications was
= 46, of which
= 35/46 (76%) were to seek permission to conduct a CT, and
= 31/35 (88.6%) were found registered with CTRI as on April 01, 2019. Of the
= 46 purposes,
= 33/46 (71.7%) were approved. Of the
= 29 INDs discussed,
= 19/29 (65.52%) were of the Indian origin.
Although a majority (65%) of INDs discussed in the meetings were of the Indian origin, the drug discovery was not in line to tackle the top ten causes of years of life lost prematurely (barring ID).
Although a majority (65%) of INDs discussed in the meetings were of the Indian origin, the drug discovery was not in line to tackle the top ten causes of years of life lost prematurely (barring ID).
Abnormal laboratory values are a common reason for the exclusion of participants in clinical studies, increasing the recruitment time and cost during conduct. The use of sample-specific reference intervals (RIs) may help to address this issue. Hence, the present study derived site-specific RIs using the department laboratory database and compare the proportion of "out of range" (OOR) values between the new and the old RIs used by the trial site.
Institutional ethics committee approval was obtained. Data for hematology and biochemistry parameters were analyzed. Normality was assessed and RIs computed using nonparametric method. Data were partitioned for gender and descriptive statistics applied for demographics. The OOR values based on new RIs were compared with old RIs using Chi-squared tests. Between gender OOR proportions compared using Chi-squared test (significance at
< 0.05). Post hoc analysis was performed with Beasley's technique.
Data of 601 participants were analyzed. The median (Inter Quartile Range) age was 22 (47) years and 64.72% were male. New RIs for key parameters were Haemoglobin (9.3-16.5 g/dl), alanine aminotransferase (11.4-47.74 U/I), aspartate aminotransferase (8.8-58 U/I), total bilirubin (0.27-1.4 mg/dl), and creatinine (0.59-1.36 mg/dl). www.selleckchem.com/ALK.html Post partitioning, the RI for hemoglobin (g/dl) was lower (8.72-15.72) in females. The proportion of OOR values were lower with new RIs relative to old laboratory RIs (
< 0.0001).
A reduction in the proportion of OORs and a change in the upper and lower bound laboratory intervals with new RIs emphasize the need for sample-specific ranges to prevent unnecessary exclusions of volunteers from trials.
A reduction in the proportion of OORs and a change in the upper and lower bound laboratory intervals with new RIs emphasize the need for sample-specific ranges to prevent unnecessary exclusions of volunteers from trials.Clinical research is an essential part of evidence-based medicine. The conduct of high-quality clinical research requires the backing of strong infrastructure, especially well-trained clinical research professionals. Tata Memorial Centre is the largest public cancer center in India and has been offering a Masters degree in Clinical Research since 2014. In this article, we look at the need for clinical research training, the evolution of this course and the impact it has had on clinical research capacity in India.The advent of digital technologies has been well blended with every aspect of human lives. Despite not being a new concept, the adoption of digital health technologies in clinical research, i.e., digital clinical trial has not been utilized extensively. However, with the prevailing COVID-19 pandemics, such transformation in clinical trial seems imminent. Few components of a trial such as consent, remote site monitoring, recruitment process which can be modified through digital technologies, are further specified by the regulatory authorities such as FDA and EMA. However, such novel method cannot be implemented without facing any limitations. All stakeholders pertinent to virtual clinical trial including the provider of digital technologies should align themselves with the patient-centric approach to propagate this concept. It is expected that such a transition is well accomplished and adopted by the sponsors without any compromise in scientific as well as ethical standard.
Cost-utility studies are crucial tools that help policy-makers promote appropriate resource allocation. The objective of this study was to evaluate the extent and quality of cost-utility analysis (CUA) in India through a systematic literature review.
Comprehensive database search was conducted to identify the relevant literature published from November 2009 to November 2019. Gray literature and hand searches were also performed. Two researchers independently reviewed and assessed study quality using Consolidated Health Economic Evaluation Reporting Standards checklist.
Thirty-five studies were included in the final review. Thirteen studies used Markov model, five used decision tree model, four used a combination of decision tree and Markov model and one each used microsimulation and dynamic compartmental model. The primary therapeutic areas targeted in CUA were infectious diseases (
= 12), ophthalmology (
= 5), and endocrine disorders (
= 4). Five studies were carried out in Tamil Nadu, four in Goa, three in Punjab, two each in Delhi, Maharashtra, and Uttar Pradesh, and one each in West Bengal and Karnataka.
