Why does Drug Safety and Effectiveness Monitoring need risk science?
So much is invested in developing a drug. As a society that cares about our citizens’ health, we must also invest in ensuring that drugs are both safe and effective.
When a drug is approved for use, it has not yet been evaluated in large populations. Typically, less than 5000 people are studied to characterize a given drug. These individuals may have minimal comorbidity and are generally only exposed to the drug being tested, without co-exposure to other drugs.
Post-approval data collection in real world populations is needed to fully characterize drug safety and effectiveness.
Risk Sciences International (RSI) has developed databases and analytic approaches to synthesize emerging evidence on safety and effectiveness, under real world conditions of use.
"Wherever the art of Medicine is loved, there is also a love of Humanity."
RSI and Drug Safety and Effectiveness Monitoring
RSI is committed to its continuing focus on the reduction of risk, believing that drugs are indeed necessary but also in need of better evaluation. RSI has developed a comprehensive Drug Safety and Effectiveness Monitoring (DSEM) program for monitoring new and existing drugs in large real world populations.
Therapeutic products are important determinants of population health. Used wisely, pharmaceutical products — both prescription and over-the-counter — can enhance patient health and improve quality of life. RSI experts seek to use their skills in risk science to ensure that such products are both safe and efficacious, in order to achieve maximum possible benefit without incurring unnecessary risks.
Most people will take medicines to treat specific health conditions at some point in their lives — some people will also be prescribed multiple drugs simultaneously by their health care provider. RSI seeks to maximize the important contributions that therapeutic products can make to treating disease and enhancing quality of life.
What is RSI's expertise in Drug Safety and Effectiveness Monitoring?
Risk Sciences International has data and analytic resources which support the assessment of drug safety and effectiveness.
With support from the National Research Council of Canada Industrial Research and Development Programme, RSI has developed powerful tools for analyzing the risks and benefits of pharmaceutical products. In support of DSEM, RSI has developed and continually curates several large North American databases, including:
- MedWatch (U.S.)
- Canada Vigilance (Canada)
- Cerner HealthFacts (U.S.)
These databases have been used to address diverse questions on the benefits and risks of pharmaceutical products, including drugs used to treat Parkinson disease, anti-hyperglycemics used to control diabetes, and chemotherapeutic agents used to treat breast cancer. Drug interactions (anti-platelet agents and proton pump inhibitors) have also been investigated.
Analytic resources include statistical tools such as disproportionality analysis of drug-adverse event pairs using data from Health Canada and US FDA MedWatch that RSI has curated from 1996 to the present time. RSI experts also have extensive experience in pharmacoepidemiological analyses, including analyses of the Cerner HealthFacts database which includes anonymized electronic health records on 70 million patients.
RSI helps clients to understand the evolving benefit and risk profiles of drugs through analysis of contemporary and up to date databases involving large real world populations.
In addition to in-depth analyses of these data, RSI can also provide comprehensive syntheses of currently available scientific information on the safety and efficacy of drugs using state-of-the-art methods in systematic review, incorporating pre-clinical, clinical, and post-market data.
When needed, RSI can also provide medically qualified clinical advice on the optimal use of therapeutic products in today’s increasingly complex health care systems.
Drug Safety and Effectiveness Monitoring Case Studies
RSI Staff Case Studies listed here are examples, but by no means the limits, of RSI work in Drug Safety and Effectiveness Monitoring. These are included here to provide prospective clients with a first glance into the type of work that RSI staff are qualified and able to deliver.
The review involved an analysis of the events and processes that led to public criticism of Health Canada’s handling of the drug company’s recall of a contraceptive drug due to packaging errors. The evaluation consisted of several components. First, a review and analysis were conducted of the regulatory and procedural basis of the department’s roles…Read More