Exploring digital therapeutics: The next paradigm of modern health-care industry.

In this era of 21st century, the most valuable resource is data. Digital technology can generate terabytes of data which has a tremendous potential in the modern-day world. Pharmaceuticals play an essential role in improving and maintaining the health of patients. However, their cost in health-care budget is a major issue. Due to high prevalence and unfavorable consequences, managing chronic and lifestyle disorders has now become areas of major clinical concern globally. Harnessing this digital technology in our overburdened health-care industry can improve the treatment outcome and even replace the existing treatment. Health authorities such as U.S. Food and Drug Administration (USFDA) are also acknowledging their potential. FDA's Center for Devices and Radiological Health has established the "Digital Health Program" which seeks to promote public health and provide continued regulatory clarity by enhancing outreach to digital health customers and developing and implementing regulatory strategies and policies for digital health technologies. The main focus of this article is to give an overview of digital therapeutics (DT), its clinical applications, role of regulators, and challenges ahead along with potential areas for developers and to present an update on major developments and initiatives taken in this field. The most important advantages of DT are that it has direct access to patients, decreases cost of treatment, encourages healthy lifestyle modifications, and can substitute or complement conventional treatments. Many of these models are still in infancy stage, and further research and development is needed to demonstrate their enormous potential in near future. If used judiciously, they can modernize our health-care industry.

Trends in FDA drug approvals over last 2 decades: An observational study.

INTRODUCTION: The discovery of novel drugs is critical for pharmaceutical research and development as well as for patient treatment. Repurposing existing drugs that may have anticipated effects as potential candidate is one way to meet this important goal. Systematic investigation and comprehensive analysis of approved drugs could provide valuable insights into trends in the discovery and may contribute to further discovery of newer drugs systematically. Food and drug administration (FDA's) Center for Drug Evaluation and Research (CDER) every year summarizes novel drugs, some of which are truly innovative and help in advancing clinical care. This study was conducted to find a trend in drug approvals by FDA in the last 2 decades. Awareness of these new drugs amongst the primary care physicians is also crucial as they have been prescribing these agents in the past. METHODOLOGY: In this cross-sectional study, we collected, surveyed, and analyzed drugs approved by U.S. Food and Drug Administration (USFDA) from the year 2000 till 2017 identified from ClinicalTrials.gov and online database of FDA. Drugs approved every year were assessed for total number, class of drug, indication, and category of approval. Type of accelerated regulatory pathways and reasons for speedy approvals every year were also studied. Microsoft Office Excel 2007 was used for tabulation and analysis. RESULTS: Total 209 were approved from 2000 to 2008. Out of these 9.09% were indicated for cardiovascular disorders and 12.91% for neurological disorders. Antibiotics (5.26%) and antivirals (5.74%) were least contributed, whereas anticancer drugs (11.96%) and biologics (7.17%) approval remained constant. Whereas, out of three hundred and two drugs approved during 2009--2017, 5.29% were for cardiovascular disorders, 9.93% for neurological disorders. Antibiotics (5.29%) and antivirals (5.96%) were least in number, whereas anticancer drugs (17.54%) and biologics (15.56%) approval took a steep rise in these years. Also, a wide variation in the number and category of approval was observed over a period of years. The use of fast track, accelerated approval, and priority review programs have also been steadily increasing since 2000. CONCLUSION: There has been a steady rate of introduction of new drugs by CDER over the last two decades. Expedited approval of anticancer and biologics is seen as recent trend in drug development. Relatively, slow progress in approval of drugs for neurological disorders (depression, psychosis, multiple sclerosis, etc.) and lifestyle diseases like obesity, atherosclerosis, diabetes, etc., were seen. These findings reflect more emphasis being laid down in research for anticancer drugs and biologics.

Therapeutic clinical trials to combat COVID-19 pandemic in India: analysis from trial registry.

OBJECTIVES: With the emergence of Novel corona virus, hunt for finding a preventive and therapeutic treatment options has already begun at a rapid pace with faster clinical development programs. The present study was carried out to give an insight of therapeutic interventional trials registered under clinical trial registry of India (CTRI) for COVID-19 pandemic. METHODS: All trials registered under CTRI were evaluated using keyword "COVID" from its inception till 9th June 2020. Out of which, therapeutic interventional studies were chosen for further analysis. Following information was collected for each trial: type of therapeutic intervention (preventive/therapeutic), treatment given, no. of centers (single center/multicentric), type of institution (government/private), study design (randomized/single-blinded/double-blinded) and sponsors (Government/private). Microsoft Office Excel 2007 was used for tabulation and analysis. RESULTS: The search yielded total of 205 trials, out of which, 127 (62%) trials were interventional trials. Out of these, 71 (56%) were AYUSH interventions, 36 (28.3%) tested drugs, 9 (7%) tested a nondrug intervention, rest were nutraceuticals and vaccines. About 66 (56%) were therapeutic trials. Majority were single-centered trials, i.e. 87 (73.7%). Trials were government funded in 57 (48.3%) studies. Majority were randomized controlled trials, i.e. 67 (56.8%). AYUSH preparations included AYUSH-64, Arsenic Album, SamshamaniVati etc. CONCLUSIONS: The number of therapeutic interventional clinical trials was fair in India. A clear-cut need exists for an increase in both quantity and quality of clinical trials for COVID-19. Drug repurposing approach in all systems of medicine can facilitate prompt clinical decisions at lower costs than de novo drug development.

Critical Issues and Recent Advances in Anticoagulant Therapy: A Review.

As the population is aging, clinicians are coming across more patients with atrial fibrillation and venous thromboembolism requiring anticoagulation to prevent stroke and systemic embolisms. Due to a high prevalence and unfavorable consequences, managing thromboembolic diseases have become areas of clinical concern. Traditional anticoagulants like heparin, low molecular weight heparin and warfarin have been used for the prevention and treatment of venous and arterial thromboses. But, issues of bleeding, parenteral route of administration, or the need for frequent monitoring due to variability in response respectively limit their use. The article gives an overview of coagulation along with existing therapy available for anticoagulation and to present an update on utility and recent advances of new oral anticoagulants (NOACs) beginning from their nomenclature, advantages, disadvantages, precautions and contraindications compared with those of vitamin K antagonists (VKAs) based on a large number of recent studies and clinical trials.

Utilization of antimicrobial agents in patients on ventilator in medical Intensive Care Unit at a tertiary care teaching hospital: A prospective study.

BACKGROUND: The burden of bacterial infections is huge and grossly underrepresented in the current health-care system. Inappropriate use of antimicrobial agents (AMAs) poses a potential hazard to patients by causing antibiotic resistance. In addition, the field of antimicrobials is witnessing constant development and introduction of new drugs for which holistic utilization, effectiveness, and side-effects studies are the need of the hour. The current study aims at studying the prescription pattern of AMAs in patients on ventilator and focuses on their prescribing trends. METHODOLOGY: A prospective, observational study was conducted in Medical Intensive Care Unit (ICU) of a tertiary care hospital of Western India for 6 months. Prescription pattern of AMAs was analyzed using predesigned format. STATISTICAL ANALYSIS: Descriptive statistics was used being an observational study. RESULTS: Five-hundred and twenty patients who were on ventilator and were prescribed one or more AMAs were enrolled in the study with a mean patient age of 40.7 years. The intended purpose of the use of AMAs was prophylactic in 59% of patients. Empirical therapy was given in 92% of patients. ß-lactams group of AMAs along with metronidazole were most frequently used. 73% required concurrent use of two or more AMAs. 9% of the patients required addition or substitution of one or more other AMAs on the basis of culture and sensitivity report or inadequate clinical response and expert opinion. The outcome of therapy with AMAs showed infection was effectively prevented in 34% of the patients. CONCLUSION: This study provides a baseline data for improving the utilization of AMAs in ICU settings by rationalizing their use and also carrying out further studies on prescribing pattern of AMAs in a tertiary care unit.