August 11, 2018

We’re All Part of One Giant Big Pharma Study

  • by Jose Smithe
  • 3 Years ago
  • Comments Off

If you take one or more prescriptions on a regular basis, it is possible that the pharmaceutical company behind your medications has information on you. As big pharma aggressively pursues access to medical records and clinical data, we are all gradually becoming part of one giant study.

A great article published by Reuters earlier in 2018 explains how pharmaceutical companies are striking deals to get their hands on patient health records. They are also working with data analysts in the hopes of making use of the information found in those records. To what end? To learn just how their medications are performing in the real world.

This is not necessarily a bad thing as long as data analysis is controlled. Unfortunately, there’s really no way to verify the integrity of the system. Who really knows what big pharma is actually doing with the information they are being given? We should be able to trust that nothing unseemly will happen, but there are no guarantees.

Clinical Studies Only Go So Far

Setting aside the security concerns for now, it is actually quite fascinating to more closely examine what it is big pharma is doing. For starters, it’s important to know that pharmaceutical companies go through an extensive, costly, and time-consuming process in order to get new drugs to market. A new drug can take a decade and millions of dollars to develop, get through the testing phase, and win approval from the FDA.

An important part of the process is conducting clinical studies. Drug makers put their medications through a battery of tests using subject patients over predetermined amounts of time. They have to conduct multiple tests in order to verify results. But even with all the testing they go through, drug makers are still left with a limited data set to work with.

More often than not, what they’re really trying to prove is that their new drugs will do no harm. If a particular drug shows promise in terms of efficacy, that’s a bonus. No harm and a little bit of promise is enough to get FDA approval. But big pharma wants more. They want to know how their medications are faring among the general population as opposed to their clinical subjects. Thus, they need data.

Real-Life Data Exploding

As stated earlier, what big pharma is now doing with big data is not necessarily a bad thing. In fact, if it leads to new regulations allowing the fast tracking of drugs and devices proven to be safe, the end result could be more effective medicines getting to market more quickly and at a lower price.

The good news is that big pharma has made a lot of headway in their real-life data collection. According to Reuters, some 1,800 clinical studies involving real-world data had been started since 2006. About half of them were started within the last three years. Three hundred of those studies got underway in 2017. As big pharma and big data get together with more frequency, the volume of real-life data is exploding.

Key to making use of all the data is analyzing it properly, explains Rock West Solutions. The Southern California company specializes in data analysis and signal processing relating to medical devices. They say that proper analysis is the single most important factor in determining whether real-life clinical studies yield any valuable results.

You may think you’ve never been part of a large-scale clinical study before, but think again. Thanks to the marriage between big pharma and big data, you might be participating in a study right now without even knowing it.

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