January 03, 2018 | Pharma and Life Sciences
Over the past few decades, usage of computers and electronics to capture and store huge amount of data has been on the rise, especially in the pharmaceutical sector. Initially used for record keeping and minimizing paperwork, this data is now, to a great extent, used to conduct clinical trials and for better design of the pharma industry. This data also helps in getting access to Real-World Evidence (RWE). Real-world evidence quite literally means evidence that is captured from the real world under multiple settings outside the typical clinical research settings.
Need to Combine RWE and RCT
Clinical trials play a crucial role in determining the safety and reaction of drugs by testing it on a representative pool of population (Randomized Controlled Trials) chosen carefully with a said health condition. Required approvals are obtained and drugs are made available to the masses. However, healthcare providers and payers are challenging the safety and efficacy measured using randomized controlled trials (RCT) and asking for more real-life data to validate the usage and effect of drugs. What happens when drugs are made available to the masses? It might so happen that the representative pool of people never experienced complications of drugs due to the presence of more than one disease.
When it comes to pharmaceuticals, stakeholders have started relying on outcome-based models rather than traditional RCTs. Patients are looking for best treatments for their diseases. Healthcare providers are looking for recorded data proof that a particular drug is facilitating the treatment, thus bringing added cost efficiency and profits. Payers are careful in spending their money and seeking return on investment justifications along with demonstrations in advance.
Pharmaceutical companies need to adopt a model by combining both RWE and RCTs to evaluate not only the cost effectiveness of the drug in real-world scenario but also forecast the impact it can have on the quality of healthcare. Such evidence can influence healthcare decisions, making it more personalized to meet characteristics of individual patients. The data from electronic patient records and databases collected over a period of time will enable healthcare companies to answer questions that were previously not feasible.
Application of RWE