Technology in Clinical Trials: Are you plugged?

Kenneth G. Faulkner, Corporate Vice President, Patient Technology Solutions, PAREXEL InformaticsPAREXEL Informatics is a technological innovation platform that makes the process of drug development faster, more precise, traceable, and more productive.

Technology has completely altered the way all of us do business. We have access to a huge amount of information that just a few years ago was either impossible or impractical to collect. My smartphone is filled with applications which routinely monitor my location, activity, and behaviors - information which I have agreed (at least passively) to share with a multitude of vendors. In the field of pharmaceutical research, the explosion of available information is changing the way we look at our industry.Just as with smartphone apps, the challenge is no longer collecting the data. Instead, the challenge rests in knowing what data to collect and then understanding how the data can be used. For example – consider the financial industry. Financial transactions are done by most of us using online tools and smart phone apps. It is extremely easy to trade stocks almost instantly once we have set up our access. Technology is readily available which makes this fast, easy, and secure. However, the real challenge is knowing what stocks to buy or sell, and when to buy or sell them. Without the proper knowledge and experience, you can get lose a lot of money quickly through inexperienced use of financial technology.
Healthcare is going through the same transition. Many of us also voluntarily strap on activity monitors that track every step and heartbeat. We can also monitor and evaluate our sleep patterns using devices and smartphone apps. More sophisticated patch based monitors incorporate sensors to evaluate not only activity and heart rate, but also breathing (including events like a cough or sneeze), skin temperature, posture (and falls), blood sugar levels – with the data being continuously connected and sent via wireless connections to healthcare providers and researchers. The challenge is no longer collecting the data. The challenge is knowing what data to collect and understanding how to use it. In many areas, the field of clinical research has always been led by technology that often outpaces our understanding of how to use it. Medical imaging is a classic example - the first x-ray image was taken in 1895 by Wilhelm Röntgen of his wife’s hand. The technology was quickly advanced and used in many hospitals within a few years, yet it took decades to understand how to use the resultant data.In our business, we spend hours in discussions with researchers selecting the proper imaging endpoints to be used for a particularly clinical trial. For example, details about what type of image should be collected (x-ray, MRI, CT, ultrasound, etc.), what anatomy will be imaged, how often the images should be acquired, how the images should be measured and evaluated- all must be determined prior to starting a clinical study.

Financial transactions are done by most of us using online tools and smart phone apps. It is extremely easy to trade stocks almost instantly once we have set up our access

The technology explosion is changing how we approach clinical studies. As healthcare providers and researchers, issues such as privacy and data access must be carefully controlled and monitored. These issues are being debated on a much larger stage but will certainly play a role going forward. For our industry, a major challenge rests in collecting the right data which can be directly related to measurable clinical outcomes.Just as too little data can cause a study to fail, too much data (or the wrong kind of data) can lead to incorrect conclusions and potentially a study failure as well. With the right data, interpreted in the right way, we have the chance to improve and accelerate the clinical trial process. This will ultimately result in a faster path to approval for efficacious and safe treatments which can then get to the patients who need them the most.