Perspectives in clinical research
-
Post-operative pain is one of the problems, wherein lack of control on it has many side-effects such as tachycardia, hypertension, myocardial ischemia, decreased alveolar ventilation, and poor wound healing. ⋯ A single pre-operative oral dose of pregabalin 150 mg is an effective method for reducing post-operative pain and pethidine consumption in patients undergoing orthopedic surgery.
-
Mean platelet volume (MPV) and platelet distribution width (PDW), markers of platelet reactivity, and white blood cell count (WBC-C), a marker of inflammation, have been shown to be predictive of unfavorable outcomes among survivors of ST elevation myocardial infarction (STEMI). we aimed to evaluate the value of admission of MPV, PDW and WBC-C for the prediction of ST segment resolution, in patient with acute STEMI treated with Streptokinase. ⋯ MPV, PDW and WBC-C at admission might be valuable in the prediction of impaired STR and in planning the need for adjunctive therapy to improve outcomes with STEMI treated with Streptokinase. We can speculate that acute STEMI patients having MPV-PDW and WBC-C values above their's cut off patients should be considered for stronger antiplatelet and helps anti inflammation treatment to be able to attain a favorable ST resolution and better clinical outcome.
-
The last decade has witnessed globalization of drug development with early phase studies being increasingly placed in the developing world. Whether research related ethical principles around informed consent, adverse event (AE) reporting, post trial drug commitments and others are being observed, merits evaluation ⋯ The survey revealed a good understanding of the ethical issues around conduct of clinical research in a developing country. The sooner ethical institutions and practices are fortified, the better it is for communities, patients, investigators and pharmaceutical sponsors.
-
Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. ⋯ Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices.