When the drug/product reaches the market, there are situations in real world settings that are very different from a controlled clinical trial setting and collecting the data and analyzing them can give us a lot of information on epidemiological trends, co-morbid conditions and co-medications, patient outcomes, off label indications and can help in updating the labels of the drug based on evidence. Data can be collected from different sources like hospitals, clinics (observational studies), wearable apps, and mobile apps and a robust analysis of this data (big data) can come up with scores of information. These results can be published and form part of internal reports and help in policy making and patient care at a larger level.
Pharmaceutical industry continually works towards bringing new drugs to the market and aims to improve the patient care. Although, clinical trials give us a good information about the efficacy and safety of a drug in a well-controlled atmosphere, it is equally important to know how a drug performs in the real world (i.e. an uncontrolled environment). We need to understand the role of a drug in improving patients’ outcomes and what all factors come into the picture. The answer lies in “Real world evidence solutions (RWEs).” It gives you insights on various aspects like drug safety, pharmaco-epidemiology, health economics and outcomes research and helps in better decision making. This is done via collection of real world data which includes clinical and economic data reported by patient registries, administrative claims/bills, hospitals/events, electronic health records, surveys, longitudinal cohorts, and literature review.
Unlike the conventional/traditional clinical trials which only consider the safety and efficacy of a drug in a controlled population, RWES addresses the following concerns:
- Economic burden of a disease
- Benefit of a new intervention and its economic implications
- Evaluating new treatment versus the available alternatives
- Incremental cost of a treatment: risk versus benefit
These evaluations are ultimately translated to clinical, economic, and humanistic outcomes of a treatment. The present situation demands RWES to fully understand the value of a product and its potential in real-world clinical practice. Evaluating a drug only on basis of its efficacy and safety is no longer sufficient to launch a product for clinical use.
Turacoz, being a growing organization is making its place in the world of RWE. We are collaborating with clients to provide RWES that can support the pharmaceutical products throughout their life cycle. We have worked on several such studies for our clients across the globe. Our services include data collection, data analysis, report writing and publication. The process involves end to end support for observational studies, registries, epidemiological and retrospective studies.
