Randomized controlled trials (RCTs) are the gold standard for measuring the safety and efficacy of drugs. However, they are being challenged by payers and health care providers since they are looking for real world evidence (RWE) to validate whether the new intervention provides similar safety and efficacy as reported in RCT data. RWE uses real world data (RWD) to generate insight, foresight, and explorative findings on diseases, products, and patient populations. There are varied sources of RWD such as administrative data, large pragmatic trials, registries, electronic health records, and health surveys. RWE approaches are increasingly becoming the normal practice in developed countries to bring a product to the healthcare market and to ensure its significance in clinical practice. The Indian healthcare sector is growing at a brisk pace and is grasping up with the principles of health economics and outcome research, thereby exhibiting the value of real-world insights in healthcare decision. India has taken a step toward RWE by developing a framework to assist health care providers in harmonizing RWD for economic, clinical, and humanistic outcome.

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Introduction and Objective Ivermectin (IVM) and doxycycline (DOXY) have demonstrated in-vitro activity against SARS-CoV-2, and have a reasonable safety profile. The objective of this systematic review was to explore the evidence in the literature on the safety and efficacy of their use as monotherapy and combination therapy in COVID-19 management. Methods After prospectively registering the study protocol with the Open Science Framework, we searched PubMed, Google Scholar, clinicaltrials.gov, various pre-print servers and reference lists for relevant records published until 16 February, 2021 using appropriate search strategies. Baseline features and data pertaining to efficacy and safety outcomes were extracted separately for IVM monotherapy, DOXY monotherapy, and IVM + DOXY combination therapy. Methodological quality was assessed based on the study design. Results Out of 200 articles screened, 19 studies (six retrospective cohort studies, seven randomised controlled trials, five non-randomised trials, one case series) with 8754 unique patients with multiple stages of COVID-19 were included; four were pre-prints and one was an unpublished clinicaltrials.gov document. The comparator was standard care and ‘hydroxychloroquine + azithromycin’ in seven and three studies respectively, and two studies were placebo controlled; six studies did not have a comparator. IVM monotherapy, DOXY monotherapy and IVM + DOXY were explored in eight, five and five studies, respectively; one study compared IVM monotherapy and IVM + DOXY with placebo. While all studies described efficacy, the safety profile was described in only six studies. Efficacy outcomes were mixed with some studies concluding in favour of the intervention and some studies displaying no significant benefit; barring one study that described 9/183 patients with erosive esophagitis and non-ulcer dyspepsia with IVM + DOXY (without causality assessment details), there were no new safety signals of concern with any of the three interventions considered. The quality of studies varied widely, with five studies having a ‘good’ methodological quality. Conclusions Evidence is not sufficiently strong to either promote or refute the efficacy of IVM, DOXY, or their combination in COVID-19 management. Systematic Review Protocol Registration Details Open Science Framework: https://osf.io/n7r2j . Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01066-y.

The private health-care system in India is effective but expensive. Due to the absence of a comprehensive and well-penetrated insurance scheme that caters to the majority of the Indian population, most of the private health care consultations are out-of-pocket (OOP), and this is pushing many people to poverty. In this article, we describe the concept of health technology assessment (HTA), and review its possible role in improving the health-care system in India. We additionally comment on its present status and possible role of its implementation in the Indian context.

Background: We critically evaluated the risk of bias in published systematic reviews (SRs) and meta-analyses (MAs) pertaining to COVID-19 using ROBIS tool. Materials And Methods: Medline and Cochrane Central Library were searched for SRs/MAs on 14th May 2020, including studies of all designs describing various facets of COVID-19 in humans; no restrictions were applied for interventions, comparators, and outcomes. Two reviewers independently assessed all the SRs/MAs with ROBIS. Results: Out of 204 identified records, 48 SRs/MAs were included. The most frequently reviewed topics were therapy outcomes, diagnosis, and comorbidities (15, 8, and 6 papers respectively). Only 29/48(60.41%) papers had made a mention of using PRISMA or other guidelines for drafting the SR/MA. Only 5/48(10.42%) of all included SRs/MAs had low overall risk of bias as per ROBIS tool; 41/48(85.42%) had high risk of bias, 2/48(4.17%) had unclear risk of bias. The highest proportion of bias was found in data synthesis and findings (30/48, 62.50% of studies had high risk of bias), followed by study identification and selection (29/48, 60.42%). The IRR for methodological quality assessment was substantial, with the Cohen’s kappa values being 0.64, 0.68, 0.62, and 0.75 for domains 1-4 of ROBIS tool, and 0.66 for overall risk of bias assessment. Conclusion: There are serious concerns about the methodology employed to generate the results of the SRs/ MAs pertaining to COVID-19, with ‘quantity’ seemingly being given more importance than ‘quality’ of the paper.