The use and perceived value of electronic health information resources by health care professionals in the field of medicine, pharmacy, and nursing in Jazan province, Saudi Arabia.

Background: Healthcare workers increasingly use Electronic Health Information Resources (EHIRs) to make evidence-based decisions. Our study was intended to assess the perception, attitude, and practice of healthcare professionals in medicine, pharmacy, and nursing regarding their perceived value and use of EHIRs. Methods: We conducted an observational cross-sectional study using a pre-validated questionnaire among healthcare professionals in Jazan province from September 2022 to February 2023. We included healthcare professionals and interns with medical, pharmacy, or nursing degrees and excluded those who refused informed consent. Results: We included fully completed data from 294 participants, with an actual response rate of just 80.1 %. Almost 87.41 % utilized the health information resources at their workplace, with UpToDate [39.45 %] and Medscape [67.01 %] being the most frequently used medical databases. The health facilities' access to electronic health resources significantly impacted healthcare professionals' [p = 0.04] and medical interns' [p = 0.02] roles. Faculty members felt the need to access electronic health information at their workplace [p = 0.00]. Lack of time to access electronic health information due to a busy schedule was a significant reason that impacted the attitude of medical professionals [p = 0.008] and nursing staff [p = 0.025]. An excessive amount of clinically unrelated data was the primary obstacle (181/294, p < 0.0001) in using electronic health information resources. Conclusion: Our study showed the pattern of healthcare professionals using EHIRs in the Jazan province, Saudi Arabia. We believe the study's outcome can help increase the calibre of electronic health information services available to healthcare professionals and raise awareness of different EHIRs in improving clinical care.

Vibrating colon-stimulating capsule to treat chronic constipation: A systematic review.

In August 2022, the United States Food and Drug Administration issued marketing authorization for an orally administered vibrating colon-stimulating capsule for treating chronic idiopathic constipation. We aimed to review the literature systematically and synthesize evidence on the role of the vibrating capsule in chronic idiopathic constipation. A comprehensive search was conducted on PubMed, Embase, International Clinical Trials Registry Platform (World Health Organization), Cochrane Library databases, and two pre-print servers (medRxiv.org and Research Square) until 31 December 2022, to identify published pre-clinical and clinical original studies evaluating the role of the vibrating capsule in patients with chronic constipation. The studies were critically analyzed, and data were extracted. We identified thirty-three articles and five studies (one pre-clinical, one combined, and three clinical). The pre-clinical studies in dogs revealed no adverse effects of the vibrating capsule. In the clinical studies, there were significant findings observed. The number of spontaneous bowel movements per week and the proportion of patients experiencing an increase of at least one complete spontaneous bowel movement per week were both significantly higher in the group receiving the vibrating capsule compared to the group receiving the sham capsule. No treatment-related serious adverse event was noted. The mild adverse events were vibration sensation, diarrhea, and abdominal discomfort. The efficacy and safety profiles of the vibrating colon-stimulating capsule in treating patients with chronic constipation are promising. However, more robust evidence is required by conducting large randomized clinical trials before conclusively determining its wider use.

Association of serum magnesium levels with acute ischaemic stroke in patients with type 2 diabetes mellitus: a propensity score-matched case-control study.

INTRODUCTION: Magnesium (Mg) deficiency has been found to be associated with many clinical conditions, such as type 2 diabetes mellitus (T2DM), cardiovascular diseases and likewise. Studies evaluating the association between serum Mg levels and ischaemic stroke in T2DM from India are limited, and this formed the aim of this study. METHODS: We conducted a case-control study among patients with T2DM where cases had a history of acute ischaemic stroke in the preceding 2 years and controls with no such history. Data regarding sociodemographic and clinical details and laboratory parameters, including serum Mg concentration, were collected using a semistructured questionnaire. Furthermore, propensity score matching (PSM) was done to match the controls with the cases. RESULTS: We enrolled a total of 200 participants (cases: 75 and controls: 125), but after PSM, 149 participants (cases: 75 and control:74) were analysed. The serum Mg concentrations were significantly low (p<0.001) among the cases (mean (SD)=1.74 (0.22)) when compared with the controls (mean (SD)=1.95 (0.13)). For every 0.1 mg/dL decrease in serum Mg concentration, the odds of ischaemic stroke increase by approximately 1.918 times (95% CI 1.272 to 2.890; p=0.002). CONCLUSIONS: The mean Mg level in the ischaemic stroke group was significantly low compared with the no stroke group in patients with T2DM. We recommend further controlled studies to evaluate the role of Mg supplementation in the management of acute ischaemic stroke.

Vitamin D deficiency in rheumatoid arthritis patients of India - a single-arm meta-analysis.

Background: Vitamin D deficiency is commonly seen in patients with rheumatoid arthritis (RA). Objectives: This meta-analysis is aimed to determine the prevalence of Vitamin D deficiency in RA patients in India and also to evaluate the association between vitamin D level and disease activity. Methods: The relevant works of literature were identified through multiple databases and data was extracted from eligible studies independently. A single-arm meta-analysis was performed to estimate the prevalence of Vitamin D deficiency in RA patients in an Indian setup and its association with disease activity. A total of 15 studies was included in the analyses. Results: The mean serum vitamin D level was 19.99 ng/ml [95% CI 16.49-24.23]. The proportion of patients with low vitamin D level was 0.80 [95% CI 0.65- 0.90], Vitamin D deficiency was 0.56 [95% CI 0.31-0.77] and vitamin D insufficiency was 0.20 [95% CI 0.12- 0.32]. A negative relationship was seen with serum vitamin D and disease activity score. Conclusions: The results demonstrate significant low levels of serum vitamin D levels in patients with RA and established a negative correlation of Vitamin D with RA disease activity. The current evidence suggests a rationale for Vitamin D supplementation in the management of RA.

A comprehensive evaluation of the safety of ipilimumab, nivolumab and their combination therapy: A systematic review and network meta-analysis.

BACKGROUND: Immune checkpoint inhibitors (ICIs) have changed the landscape of management of advanced cancers. It is imperative to evaluate the safety of nivolumab and ipilimumab based therapies. This study was aimed to assess the comparative safety profiles of ipilimumab, nivolumab and their combinations. MATERIALS AND METHODS: We searched PubMed, Embase, and the CENTRAL for randomised controlled trials of ipilimumab and nivolumab. The outcome measures were treatment-related adverse events [TRAEs], TRAEs of grade 3-5, treatment discontinuation due to TRAEs [TDTRAEs], TDTRAEs of grade 3-5, serious adverse events [SAEs] and SAEs of grades 3-5. We performed a network meta-analysis using the Bayesian approach in R version 4.0.3. RESULTS: We identified 42 RCTs for final analysis. The treatment ranking for TRAEs revealed that nivolumab 240 mg/week and nivolumab 3 mg/kg/week were safer (0.84 and 0.81 in SUCRA); for TRAEs of grade 3-5, nivolumab 3 mg/kg/week and nivolumab 240 mg/week were safer (0.83 and 0.75 in SUCRA); for TDTRAEs nivolumab 3 mg/kg/week and ipilimumab in combination with other drugs were safer (0.87 and 0.64 in SUCRA) and for TDTRAEs of grade 3-5, nivolumab 3 mg/kg/week was safer (0.85 in SUCRA). Nivolumab 3 mg/kg/week and nivolumab 240 mg/week were safer (0.79 and 0.76 in SUCRA) for SAEs and nivolumab 3 mg/kg/week was safer for SAEs of grade 3-5 (0.78 in SUCRA). CONCLUSION: Nivolumab 3 mg/kg biweekly, nivolumab 240 mg weekly and nivolumab 3 mg/kg plus ipilimumab 1 mg/kg triweekly could be preferred due to the relatively low risk of TRAEs, TDAEs and SAEs.

Efficacy and Safety of Liraglutide 3.0 mg in Patients with Overweight and Obese with or without Diabetes: A Systematic Review and Meta-Analysis.

Background: Liraglutide in a 3.0 mg subcutaneous dose daily is approved for weight reduction. Objectives: Objectives are to evaluate the efficacy and safety of liraglutide 3.0 mg in patients with overweight and obesity irrespective of diabetic status. Methods: We conducted an electronic database search in PubMed, Embase, and https://ClinicalTrial.gov to identify all randomized control trials (RCTs) that evaluated the efficacy and safety of liraglutide 3.0 mg dose compared to placebo in overweight (≥27 kg/m2) and obese (≥30 kg/m2) patients above 18 years of age. Results: We compared the pooled estimate of the study results between liraglutide 3.0 mg groups and placebo groups both in diabetic and nondiabetic patients. The efficacy outcomes that were found to be significant among respective studies involving nondiabetic patients vs. diabetic patients were mean change in body weight from baseline: 12 studies [MD = -5.04 kg (95% CI = -5.60, -4.49), P < 0.001, I 2 = 92.95%] vs. 2 studies [MD = -4.14 kg (95% CI = -4.95, -3.32), P < 0.001, I 2 = 0%], reduction in waist circumference from baseline: 8 studies [MD = -3.64 cm (95% CI = -4.43, -2.85), P < 0.001, I 2 = 96.5%] vs. 2 studies [MD = -3.11 cm (95% CI = -3.88, -2.34), P < 0.001, I 2 = 0%], BMI reduction from baseline: 5 studies [MD = -1.95 kg/m2 (95% CI = -2.22, -1.68) vs. 1 study [MD = -1.86 kg/m2 (95% CI = -2.14, -1.57), P < 0.001, I 2 = 0%, P < 0.001, I 2 = 95.6%], proportion of patients losing more than 5% of weight loss from baseline: 8 studies [RR = 2.21, (95% CI = 1.89, 2.58), P=0.03, I 2 = 59.02%] vs. 2 studies [RR = 2.34, (95% CI = 1.93, 2.85), P=0.39, I 2 = 0.00%], and 10% weight loss from baseline: 7 studies [RR = 3.36, (95% CI = 1.92, 5.91), P=0.00, I 2 = 87.03%] vs. 2 studies [RR = 3.64, (95% CI = 2.46, 5.40), P=0.81, I 2 = 0.00%]. Safety outcome assessment with use of liraglutide 3.0 mg compared with placebo in respective nondiabetic vs. diabetic patients revealed significant proportion of patients experiencing the adverse events: 9 studies [RR = 1.11, (95% CI = 1.04, 1.18), P=0.00I 2 = 79.15%] vs. 2 studies [RR = 1.06, (95% CI = 1.01, 1.11), P=0.42, I 2 = 0.03%] but similar risk of serious adverse events: 9 studies [RR = 1.03, (95% CI = 0.70, 1.51), P=0.26, I 2 = 18.54%] vs. 2 studies [RR = 1.11, (95% CI = 0.67, 1.84), P=0.25, I 2 = 23.77%] and TDAEs: 4 studies [RR = 0.89, (95% CI = 0.35, 2.28), P=0.03, I 2 = 61.89%] vs. 1 study [RR = 2.53, (95% CI = 1.00, 6.37)]. However, the pooled estimates irrespective of the glycaemic status were mean change in body weight from baseline: 14 RCT [MD = -4.91 kg (95% CI = -5.43, -4.39), P < 0.001, I 2 = 92.35%], reduction in waist circumference from baseline: 10 studies [MD = -3.55 cm, (95% CI = -4.21, -2.89), P < 0.001, I 2 = 94.99%], BMI reduction from baseline: 6 studies [MD = -1.86 kg/m2, (95% CI = -2.14, -1.57), P < 0.001, I 2 = 96.14%], and proportion of patients losing more than 5% and 10% of weight from baseline: [RR = 2.23, (95% CI = 1.98, 2.52), P < 0.001, I 2 = 48.87%] and [RR = 3.28, (95% CI = 2.23, 4.83), P < 0.001, I 2 = 78.98%], respectively. Also, the proportion of patients experiencing the adverse event was more with liraglutide 3.0 mg compared with placebo 11 study [RR = 1.09, (95% CI = 1.04, 1.15), P < 0.01, I 2 = 76.60%] and similar risk for both serious adverse events: 11 studies [RR = 1.09, (95% CI = 1.04, 1.15), P < 0.01, I 2 = 76.60%] and TDAEs: 5 studies [RR = 1.14, (95% CI = 0.50, 2.60), P < 0.01, I 2 = 64.93%] with liraglutide compared with placebo. Conclusions: Liraglutide in 3.0 mg subcutaneous dose demonstrated significant weight reduction with a reasonable safety profile for patients with overweight or obesity regardless of diabetic status compared to placebo.

Impact of disease-modifying therapies on MRI outcomes in patients with relapsing -remitting multiple sclerosis: A systematic review and network meta-analysis.

BACKGROUND: Multiple sclerosis (MS) is a chronic autoimmune inflammatory demyelinating disorder of the central nervous system. The clinical presentation supported by characteristic findings on MRI forms the backbone of the current diagnostic criteria. This study was aimed to investigate the efficacy based on MRI outcomes of FDA approved disease-modifying therapies (DMTs) for relapsing-remitting MS (RRMS). MATERIALS AND METHODS: We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials for randomised controlled trials (RCTs) of DMTs. The outcome measures were the mean number of T2 [new/enlarging lesions], new T1 [gadolinium-enhancing (Gd+) T1 and hypointense T1] lesions in brain MRI performed at 12 months or 24 months. We performed a network meta-analysis using the frequentist approach in STATA version 16.0. RESULTS: We identified 26 RCTs for final analysis. Interferon ß-1a and placebo were the most common comparison treatment. Ocrelizumab was more effective in reducing the number of Gd+T1 lesions. Dimethyl fumarate 480 mg was relatively better in reducing the number of new T2 lesions. The treatment ranking showed that ocrelizumab and dimethyl fumarate 480 mg were more efficacious (1 and 0.9 in SUCRA, respectively) for reducing the number of new Gd+T1/hypointense lesions; dimethyl fumarate 480 mg/720 mg and natalizumab were more efficacious (1.0, 0.9 and 0.8 in SUCRA, respectively) to reduce the number of new T2 lesions. CONCLUSION: Ocrelizumab, dimethyl fumarate 480/720 mg and natalizumab demonstrated favourable MRI outcomes in patients with the RRMS.

Cobra envenomation in an elderly female mimicking brain death- A case report.

Snake bite envenomation is one of the most toxicology-related cause that can mimic brain death. This is a case report of 73-year-old elderly female, a hypertensive on treatment, who presented with chief complaints of cobra snake bite on the dorsum of right hand. On admission, patient had dyspnea, bilateral ptosis and ophthalmoplegia. In the next 10-15 min, her symptoms got worsened for which she was administered intravenous doses of atropine (2 mg), neostigmine (0.5 mg) and anti-snake venom. She developed respiratory arrest, hence was intubated and was started on mechanical ventilation. On assessment following 12 h post admission, the patient had Glasgow Coma Scale (GCS)-E1V1M1, with pupils bilateral 2.5 mm sluggishly reacting to light. After 36 h post admission, patient began to show signs of recovery. She began to blink her eyes, follow objects and attempted to move her limbs on command. On day 3, Patient was weaned off from the ventilator, extubated two days later and discharged home on Day 7. This case report highlights a unique presentation of cobra bite induced neuroparalytic syndrome mimicking brain death in an elderly patient. Furthermore, the life-threatening presentation of cobra envenomation mandates the use of higher doses of Polyvalent snake antivenom (PSA) to reverse the neuroparalytic toxicity. We should consider the role of anticholinesterase as an adjunctive therapy to PSA in severe cobra envenomation.

Novel Study Designs in Precision Medicine - Basket, Umbrella and Platform Trials.

The concept of 'one size fits all' - one treatment for patients with a particular disease, seems to be outdated. The advent of precision medicine has prompted profound changes in clinical research and it allows researchers to predict more accurately, the prevention and treatment strategies for a specific disease population. Novel study designs are, therefore, essential to establish safe and effective personalized medicine. Basket, umbrella and platform trial designs (collectively referred to as master protocols) are biomarker enrichment designs that allow for testing more than one hypotheses within a protocol, thus accelerating drug development. These trial designs tailor intervention strategies based on patient's risk factor(s) that can help predict whether they will respond to a specific treatment. Basket trials evaluate therapy for various diseases that share a common molecular alteration, while umbrella trials evaluate multiple targeted therapies for a single disease that is stratified into subgroups based on different molecular alterations/ risk factors. These designs are complex and their major limitations stem from the fact that it would be inappropriate to completely replace histological typing with molecular profiling alone. However, in the upcoming decades, these trial designs are likely to gain popularity and improve the efficiency of clinical research. This article briefly overviews the characteristics of master protocol designs with examples of completed and ongoing clinical trials utilizing these study designs.

Evaluation of efficacy and safety of fosfomycin versus nitrofurantoin for the treatment of uncomplicated lower urinary tract infection (UTI) in women - A systematic review and meta-analysis.

Urinary tract infections (UTI) are among the most frequent medical conditions requiring outpatient treatment. Single dose oral fosfomycin (300 mg) and the older nitrofurantoin (100 mg for 5 days) have been found to be more effective than other first-line drugs in multiple studies. This systematic review and meta-analysis were carried out with the objective of evaluating their comparative efficacy and safety in the management of uncomplicated UTI. Two authors independently searched PubMed, Cochrane Central, Embase, and Google Scholar till Nov 2020 using MeSH terms and free text. Randomized controlled trials (RCTs) comparing both drugs for efficacy and safety in uncomplicated UTI in adult women were included. The primary outcome measures were microbiological and clinical cure rates. The search resulted in n = 663 studies out of which only four studies (three for treatment of uncomplicated UTI in women and one for asymptomatic bacteriuria in pregnancy) satisfied the selection criteria. No significant differences in clinical, (RR 0.95, 95% CI - 0.81, 1.12) and microbiological cure, (RR 0.96, 95% CI - 0.84, 1.08) were found within 4 weeks of treatment. The incidence of adverse events was found to be more in fosfomycin relative to the nitrofurantoin group (RR 1.05, 95% CI - 0.59, 1.87). Hence, single-dose fosfomycin presents a potentially useful and safe treatment option for the treatment of uncomplicated UTI in women and asymptomatic bacteriuria in pregnancy.

An Audit of Interim Analyses of Randomized Controlled Trials (RCTs) Published in Three High Impact Factor Medical Journals Over a Seven- year Period (2012-2018).

BACKGROUND: Interim analysis is an integral component of clinical research and drug development in particular and helps reduce 'time to market' for an intervention or stop further development of unsafe and ineffective interventions. In this audit, we evaluated the extent of use of interim analyses in published RCTs in three leading journals and their impact on regulatory approval. METHODOLOGY: RCTs published in JAMA, NEJM and Lancet in the year 2012 to 2018 were extracted. Each RCT was scrutinized using the filter term 'Interim'. Both descriptive and inferential statistics were used to analyze the data. The factors (therapeutic areas, nature of interventions, source of funding and phases of trials) associated with Interim analysis and its impact on drug approval were analyzed. RESULTS: The majority of RCTs with interim analysis belonged to oncology (27%) and cardiology (17.2%) and were related to drugs (70%). Majority of the RCTs were in phase 3 (56.3%) and funded exclusively by Pharmaceutical industry (36.2%). A total of 2% and 14% studies led to accelerated approval and normal regulatory approval. The choice of alpha spending function was not mentioned in 44.8% studies and 21% studies used O-Brien Fleming method. A total of 18.5% studies were stopped early. The oncology trials, drug as intervention and Phase 3 trials were associated with the conduct of interim analysis which was associated with significantly higher numbers of accelerated and routine regulatory approvals. CONCLUSION: Majority of the RCTs with interim analysis were from oncology and most did not report a stopping rule. Interventions that were drugs (rather than devices or surgical procedures). and phase 3 trials (relative to other phases of RCTs). were associated with significantly higher number of interim analyses which was also associated with significantly higher number of regulatory approvals.

A case report of Arnold Chiari type 1 malformation in acromesomelic dwarf infant.

Arnold Chiari malformation is one of the commonest cause of congenital hydrocephalus. Cause of fetal development of cerebellar tonsils remains unknown and may be diagnosed at later in life. The association of Arnold Chiari malformation with acromesomelic dwarfism is not known. We report male infant diagnosed with acromesomelic dwarfism at end of gestation period on basis of antenatal ultrasonography findings. An ultrasound scan of infant head at fifth month of birth was performed in view of increasing head circumference that revealed aqueductal stenosis with dilated posterior horn of lateral ventricles in brain.

Recruitment and retention of the participants in clinical trials: Challenges and solutions.

Drug development is a tedious and expensive procedure and it takes roughly 10 to 15 years to take a potential treatment from bench to bedside and costs the pharmaceutical companies as much as USD ~2 billion for the process. Delay in investigator-initiated studies can cause financial loss to grant providers (either public or private) and investigator's reputation may also be at stake. Participant recruitment and retention are two major bottlenecks in conducting clinical trials and contribute vastly to the delays. They are essential for both scientific validity of the clinical study and economic reasons. Thus, issues in recruitment and retention should be addressed and minimized. A proper recruitment and retention plan incorporating adequate communication between all stakeholders will eventually avoid the delays in drug development and make treatments available to the consumer at an earlier date and at a more affordable price. Awareness of challenges and reviewing strategies that can optimise recruitment and retention will facilitate drug development. The article gives a first-person perspective on challenges and proposed solutions from an experienced clinical study centre in a tertiary care hospital.

An audit of reporting of conflict of interest policies among three stakeholders in Indian biomedical journals.

BACKGROUND: A conflict of interest (COI) in publication exists when the primary interest of publication is influenced by a secondary interest (financial or non-financial). International guidelines are available that can be used by journal editors to formulate their own COI policies. The present study was carried out with the objective of evaluating COI policies existing among Indian biomedical journals. MATERIALS AND METHODS: MEDLINE/PubMed and MedIND/IndMed databases were searched. Inclusions were journals that were active and indexed. Outcome measures were proportion of journals: (a) mentioning COI disclosure statement for authors, reviewers, and editors, (b) adequately explaining COI, (c) referring to three international guidelines, and (d) the proportion of PubMed/other than PubMed indexed journals mentioning COI policy for authors, reviewers, and editors and providing an adequate explanation for COI. Apart from descriptive statistics, associations between indexing and COI Policy for all three stakeholders were evaluated. RESULTS: A total of n = 106 journals formed the final sample. Among them, 82 (77%) were PubMed and 24 (23%) were MedIND/IndMed indexed. COI disclosure statement was mentioned in 93 (87.7%) journals for authors, 10 (9.4%) for reviewers, and 06 (5.6%) for editors. Only 35 (33%) journals adequately explained COI. A total of 61 (57.5%) journals endorsed all the three international guidelines. PubMed indexing was found to be associated with approximately 19 times the odds of COI policies being present on the journal's home page relative to the journals indexed with other indexing agencies (crude odds ratio - 18.8, 95% confidence interval [4.6, 77],P < 0.0001). CONCLUSION: Very few Indian biomedical journals have COI policies for reviewers and editors and most did not explain it adequately. Nearly, a fifth of the journals we evaluated did not follow any guideline for disclosing COI.

Investigator preparedness for monitoring and audits.

Monitoring and audits are two distinct processes that ensure that the rights and safety of the participants are protected, and data integrity is maintained. The present narrative summates authors' experiences with monitoring and audits by sponsor along with challenges faced by the site. It also offers potential solutions for challenges faced during the process of monitoring and audits. It is important to remember that no monitoring or audit can ever substitute for a well-designed and articulated protocol. In addition, a determined approach by the investigator and his/her team to ensure that all aspects of the protocol are adhered to in totality will go a long way in assuring quality.

Medical case reports published in PubMed-indexed Indian journals in 2015: Adherence to 2013 CARE guidelines.

In 2013, an independent group of researchers developed the CARE guidelines, a checklist to standardise reporting of case reports. This study assesses adherence to CARE guidelines among PubMed-indexed Indian medical journals in 2015 and the extent of endorsement of these guidelines by the journals. Case reports published in 2015 in journals indexed by PubMed, belonging to the medical stream, currently active, and that had an impact factor were included for analysis. Case series and journals that were published from India but for another country were excluded. Total adherence score and classification of adherence as "excellent", "very good", "good", and "poor" as also adherence to individual components of the checklist were the outcome measures. A total of 162 journals were identified by the search strategy, of which 36 satisfied the selection criteria. In these 36 journals, 1178 case reports were published. We tested the association between the type of journal and impact factor with adherence by using the chi-squared test and generated crude odds ratios. All analyses were done at 5% significance. Based on the total percent score, no case report had excellent adherence, and 19% had good, 70.7% average, and 10% poor adherence, respectively. Among the sub-items, the best adherence was seen in the clinical findings [97.9%], followed by keywords [88.5%], and introduction [71.5%]. The items with extremely poor adherence were patient perspective [0%], informed consent [2.8%], and timeline [4.6%]. Journals with an impact factor of more than 1 had better adherence, relative to those with an impact factor lower than 1. Only one journal's website mentioned the CARE guidelines. Greater awareness needs to be created among authors, peer reviewers, and editors about using these guidelines. As informed consent is a metric of autonomy, all stakeholders must ensure its reporting.

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.