Patient using DrugStars

Real-world evidence.

Real-world evidence (RWE) and real-world data (RWD) are playing an increasing role in health care decisions today, but they could be playing a larger role.

Advances in technology and advanced analytics have long helped other industries. Now it is happening in healthcare. By leveraging deep scientific and health system expertise, DrugsDiscovered and DrugStars provide technology-enabled solutions to help you learn more about your patients.

Real world evidence is accelerating and informing almost every area of research and commercialisation these days. DrugsDiscovered and DrugStars can help you create and understand the ever-expanding, global ecosystem of this clinically-rich data in the context of your business and the patients you help.

What is real world evidence and what does it mean for Pharma?

Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD.

You have almost certainly heard the terms Real-World Data (RWD) and Real-World Evidence (RWE) – maybe you’re unsure about exactly what these things are and why they’re important? Let’s break it down a little.

Real-World Data (RWD) is healthcare information derived from outside of a clinical research setting. It often includes health data like this:

But what is driving the growing interest in Real-World Evidence?

Here are a few factors contributing to the pharmaceutical industry’s excitement about RWE:

  1. Regulators take RWE into account, meaning that it has the potential to have an effect on drug approvals and could help accelerate the drug development process, which could save pharmaceutical companies a lot of money. These savings can be used to gather more patient health data, running data trials that can help creating even more insights.
  2. Real-world evidence data complements and adds depth to existing clinical trials data by providing insights that trials alone simply can’t deliver – for instance, safety and effectiveness data from a patient’s daily life. The real-world angle ads more depth and insight that a clinical trial simply could not offer. Data is aggregated and anonymous so bias is again limited or even removed from the data set.
  3. Pharmaceutical companies, Researchers, Payers and Insurance companies, can all gather a more solid understanding of what benefits a drug offers to patients, and RWE and its underlying data can help bolster their confidence in a treatment’s effectiveness. RWE can demonstrate improved patient outcomes, indicate drop-out and can even show effects on hospitalization rates and length of stays.

The 21st Century Cures Act, passed in 2016, places additional focus on the use of these types of data to support regulatory decision making, including approval of new indications for approved drugs. US Congress defined RWE as data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials.  Read more here.
FDA Real World Evidence and Real-world data (RWD) are playing an increasing role in health care decisions.

Clinical trials are still often used, but these have no world evidence as they are more are only observational studies of the few and do not allow for a true insight into the population as they often have a strong bias in who can join. By taking the study into the real world and using world evidence it is possible to see so much more, gaining a true representation of how patients use and how they feel about their medications. It is the patient that is the real expert when it comes to medication, they rely on the medication and often take it daily giving them huge insights into the products produced.

Patients today are more comfortable than ever when it comes to electronic health solutions and are fine with reporting health issues through devices and services like health apps. They know that their real-world data is being gathered and they know that this data is then used to help them and the producers of their medication.

How DrugsDisclosed can help you gain insights

DrugsDisclosed is built on the insights gathered from the almost half a million real-world patients using the DrugStars app today. These insights are created from the millions of data points created by each user as they interact around their medication. This data is analysed and used to help the patient to get more from their medication, but it can be used for much more and by so many more companies, helping more patients.

Why is real world evidence important?

The importance of Real World Evidence comes to light when we look at some concrete examples:

What does real world data mean?

Moving forward, it will no longer be sufficient for healthcare stakeholders to rely on generalities and hypotheticlas. It is will become your obligation to use real-world data we have made available to benefit patients. A holy grail in healthcare is to match unique patient characteristics to the unique therapeutic offerings. Thoughtful use of real-world evidence (RWE) is a critical pathway to achieving this goal.

Data does not lie, it will not tell you what you want to hear, it can not be misunderstood like observational studies can and includes everyone unlike a clinical trial. Real-world evidence data can put your finger back on the pulse of patients, all you have to do is listen to them, understand their data and help them.

Health data is driving innovation, driving change and is showing better results than clinical trials when it comes to patient health. Real-World Evidence comes from the collection of data from patients.

There's more...

This platform could be the start for many, we have removed the red tape and now you can access your patient data in an easy to consume format, but there is more. We can ask specific questions based on treatment areas, demographics and much more. Today there are many ways through the popular DrugStars app that you as a company can benefit and your patients can benefit too. We have many products that you can use to help your patients and learn more about them. You can start today and save a month on your subscription fee here

Start by simply listening to them today.