Risk-based monitoring: Review of the current perceptions and toward effective implementation.

The United States Food and Drug Administration issued a guidance to industry in August 2013 on risk-based approach to monitoring. This prompted industry (sponsors and contract research organizations) to brainstorm, conceptualize, and implement risk-based monitoring (RBM) in their clinical studies and programs. The acceptance and implementation across the organizations have been variable in terms of pace and methodology.

Risk-Based Monitoring (RBM) Implementation: Challenges and Potential Solutions.

Risk-based monitoring (RBM) has disrupted the clinical trial industry, challenging conventional monitoring norms, business processes, and organizational structures. Endorsed by regulators and leading industry forums, and further driven by escalating drug development costs and enabling technology shifts making data available real time, the industry is moving from a mode of recalcitrance to acceptance. The effective implementation of RBM requires delicately interweaving changes in technology, processes, people, and perspectives.

Prevalence of erectile dysfunction and its correlates among men attending primary care clinics in three countries: Pakistan, Egypt, and Nigeria.

The prevalence and correlates of erectile dysfunction (ED) in developing countries are largely unknown. Our objectives were to determine the prevalence and associated factors of ED in three countries (Pakistan, Egypt, Nigeria) that represent very different cultures. Men 35-70y of age seeking primary medical care answered a structured questionnaire adapted to reflect local cultures.

Prazosin GITS vs atenolol in patients with hypertension and normal lipid profile: a randomized, controlled multicenter study. Hyderabad Hypertension Study Group.

Objective: To compare the long-term antihypertensive efficacy, tolerability, and metabolic effects of prazosin GITS and atenolol.

Design: Randomized, controlled, multicenter study of 26 weeks duration.

Setting: Office practices of 24 physicians in Hyderabad, Andhra Pradesh, India.