By James John
The structure that real-world data provides is by now large and it’s bound to get even larger. This is slowly transforming how medicines are evaluated. The presence of real-world data helps to dramatically improve the ability that clinical trials organizations like Veristat have to access useful evidence about products. Such data allows CROs to deliver drugs to market a lot quicker, expand their usage for new indications quickly, and also answer crucial safety questions that help guide the right and safe use of medicines. How then is real-world data a game-changer in clinical research? Keep reading to learn more.
Real-world data is used in regulatory submissions
Research companies can now gain regulatory approval depending on previous Phase studies from medical records on virtual clinical trials as real-world evidence. With such data, treatment response can be used to characterize safety and rates in a very similar population of patients in the real-world who hadn’t received the clinical trial therapy.
Increasing the indications for approved therapies
Real-world records have the potential to offer persuasive evidence for increasing the approved uses of any drug to new diseases and other types of patients. Such evidence may be used in supporting investments in different clinical studies to get approved for new indications. This means that real-world data helps save a considerable amount of time and money.
Helps in Designing more successful and effective clinical trials
When designing clinical trials, teams developing drugs must come up with a criterion they’ll use to exclude or include different patients. Real-world data then helps show the actual impact of various criteria on the possible pool of patients. When you use a limiting criterion, the data will show that you have excluded a bigger percentage of the patients suffering from the ailment you’re studying. Also, using real-world data to optimize the different criteria will help speed up patient recruitment while ensuring that you get results that are more broadly applicable. Also, data can give you guidance on how long or large your study should be to allow you to test a drug to show impacts on disease outcomes. Real-world data also, gives you that information while ensuring your study includes the right duration and size.
Protecting the patients’ safety
Today, real-world data is broadly used to supplement clinical trial data when determining a drug’s safety profile. This data is especially useful when gauging the risks of very rare yet possible serious side-effects. When it comes to some drugs, the risks that most regulators are interested in might occur in one patient out of a few thousand patients. Therefore, to collect meaningful data on such risks, you’d have to study a larger number of patients, which is not practicable to do a study that large. The thing is companies are not just analyzing information that’s already available—they’re instead ensuring that safety information gets collected.
In clinical research, the processes and expertise used in developing drugs are totally rooted in running random clinical trials. As such, companies have to grow so they can accommodate and combine real-world data with clinical trials to help evaluate available therapies much faster and efficiently.
