Perspectives in Clinical Research最新文献

Virtual clinical trials refer to clinical trials that take advantage of digital technologies, including computer and mobile device apps, web-based tools, and remote monitoring devices, for one or more of the trial processes, such as participant recruitment, counseling, informed consent, measurement of endpoints, and/or adverse event monitoring, to obviate or reduce the need for participant visits to the trial site. The advantages of such trials may include higher recruitment rates, better compliance, lower dropout rates, reduction in time for trial completion, and lower costs. The use of such trials increased manifold during the COVID-19 pandemic and is likely to continue in the future.

Background: Global evidence-based recommendations for hypertension management are periodically updated, and ensuring adherence to the guidelines is imperative. Furthermore, the current high prevalence of hypertension effectuates a high health-care cost.

Purpose: To evaluate the prescribing patterns of antihypertensive drugs and other factors affecting blood pressure (BP) with the objective of assessing the proportion of patients achieving the target BP and to perform a pharmacoeconomic analysis in a South Indian population.

Materials and methods: In a cross-sectional study, 650 patients previously diagnosed with hypertension and already on treatment with one or more drugs were included. A prospective interview of patients was done using a prevalidated questionnaire on various factors in BP control. Prescribing patterns and pharmacoeconomic analyses, namely, cost acquisition, cost of illness, and cost-effectiveness analyses were carried out.

Results: Of 650 subjects, 257 (39.54%) achieved the target BP, while 393 (60.46%) did not. A significant association of age, occupational status, monthly family income, and area of residence in addition to physical activity and diet scores, with achieving target BP was noted. A significantly higher cost of anti-hypertensive drug treatment in achieving target BP (P = 0.02) was observed. Among patients who achieved target BP, 37.35% were on monotherapy and 48.25% on multiple drug therapy compared to 46.31% and 35.62%, respectively, in patients who did not. Average cost-effectiveness ratio were found to be Rs. 20.45 and Rs. 57.27, respectively, for single and multiple drug therapies, with incremental cost-effectiveness of Rs. 194.14 per additional patient treated with multiple free drug combinations.

Conclusion: This study identified the anti-hypertensive prescribing pattern and provided insight into the various pharmacoeconomic factors that play a significant role in attaining target BP in the treated population.

Cannabis is one of the world's oldest cultivated plants and the most commonly used recreational drug worldwide. The plant relevant for medicinal use is Cannabis sativa that has two pharmacologically active ingredients - delta-9-tetrahydrocannabinol that is psychoactive and cannabidiol that does not have psychotropic activity. The policy tapestry of Cannabis has undergone a significant change in the past few decades worldwide. Different countries have diverse policies, ranging from classifying use of Cannabis as illicit, to legalization of its use, both for medicinal and recreational purposes. Cannabis products are approved for use, for instance, in multiple sclerosis and Dravet syndrome (US Food Drug and Administration). Against this backdrop, we find that the knowledge foundations for use of Cannabis in clinical trials in India are still evolving. Conducting ethical research within a clinical trials framework is essential to understand dosing, formulation, shelf life, drug-drug interaction, tolerability, and safety before establishing its utility for various indications. In the absence of guidelines or a regulatory framework for conduct of these studies, the various Institutional Ethics Committees (IECs), which are responsible for reviewing projects related to Cannabis, face unique challenges with respect to the basic requirements. The principal investigators (PIs) are equally strained to find local guidance, recommendations, and literature in support of their application to the respective IEC, thus leading to an impasse and delay in initiating the proposed clinical studies with Cannabis. The present article addresses considerations, questions, and issues that affect the conduct of these clinical studies and recommends mandatory documents and some suggested guidelines for use by both PIs and IECs to take studies with Cannabis forward until such time that an interdisciplinary regulatory framework is firmed up by regulatory authority.