Time and Motion (T&M) studies are observational studies designed to quantify efficiency-related outcomes associated with:
In-depth study and understanding of the disease or condition for which a drug or biologic is being developed is essential to the scientific foundation of any clinical development program. That’s why incorporating a natural history of disease study to evaluate patients who have been diagnosed with a specific condition or disease is well worth manufacturers’ time and effort.
A natural history study is a way to:
Unlike controlled studies, observational studies have the potential to collect data on thousands – even millions – of patients. Increasingly, manufacturers are asked for information and data that only these kinds of studies can provide.
Observational studies can be used to help manufacturers and their stakeholders understand the clinical, patient-centered, and economic burden of disease, as well as the value of different treatments in reducing that burden.
Downloading health applications on our mobile phones or tablets is becoming an increasingly popular way to learn the nutritional value of foods, track caloric intake, and log exercise activities. We can all appreciate the convenience these mobile health – or mHealth – applications provide. It makes sense, then, that mHealth can be used in clinical trials where convenience for patients and prescribers is essential to enrollment and retention.
So, what does mHealth encompass and how are pharma and biotech manufacturers using it in clinical trials?
Once a medical product is taken out of a highly controlled clinical environment and is made available through physicians to their patients, additional risks and unknown safety issues may become apparent. Therefore, proactive risk management should begin early in product development. This pre-marketing timeframe offers opportunities to:
UBC experts Krista Payne MEd, Executive Director of Value Demonstration; Safety, Epidemiology, Registries and Risk Management and Principal Scientific Consultant, and Dara Stein, MSc, Senior Research Associate, Value Demonstration, Safety, Epidemiology, Registries and Risk Management, have written a comprehensive overview on retrospective chart studies online now at PharmaPhorum.com.