On average, it takes up to 10 years and $2.6 billion to bring a new drug to market, according to data collected by the Tufts Center for the Study of Drug Development. This includes both the drugs that successfully make it to market — about 12 percent — and those that fail at some point between initial development and clinical testing.
While developing drugs that are safe and effective is the top priority for scientists, it’s also in everyone’s best interests to find ways of streamlining and speeding up the process. Not only to patients benefit from faster access to potentially life-saving treatments, but drug companies can also benefit by earning higher revenues before the drug’s patent expires. The good news is that thanks to new and emerging technologies, it’s becoming possible for new drugs to reach the market faster than ever.
Data Mining Technology
Pharmaceutical development begins with research about the specific compounds under consideration and studies that have already been completed. Researchers need to know, for example, regulatory information about their compounds, potential side effects, and other issues that could potentially affect their research. In the past, this has been an imperfect process at best, requiring months or even years of research, cross referencing, and analysis.
Thanks to data mining technology and machine learning, that process is becoming more streamlined — and more accurate. Not only are researchers able to move forward with development sooner, but their research can also identify issues that could cause a drug to fail before investing millions of dollars in additional development. In some cases, they may also be able to identify modifications to the compound before it reaches the clinical testing phase, or they may discover that the compound under investigation is not a good candidate for further development. Not only does this save money, but it allows researchers to focus on those treatments that have the most potential.
Electronical Clinical Trials
Another technology that is making a significant difference in the speed of clinical trials is eCOA, or electronic clinical outcomes assessment. An eCOA clinical trial allows patients to report study data via electronic collection methods directly to the researchers. This replaces cumbersome paper assessments, which required not only data entry but a system of checks to ensure that the data was entered accurately. In many cases, it could take up to a year or longer to complete this process and provide usable data for researchers to review.
With the electronic systems, though, it’s possible that scientists could have usable patient data within one to two weeks. This allows researchers to identify patterns and potential problems early in the research, and make necessary changes to protect both patients and the study outcome.
The role of wearables in clinical research is a hot topic these days and with good reason. A great deal of clinical research relies on patient-reported information in conjunction with clinical testing and evaluation. In either case, the data collected is merely a snapshot, and may not capture the entire experience and condition of the subject.
Wearables, on the other hand, offer real-time, accurate information over an extended period. When connected via Wi-Fi, the data can be transmitted accurately and immediately, giving the researchers more data to work with and a better overall picture of patient progress. The problem, of course, is that most wearables on the market today are designed for a consumer audience, and do not have FDA approval to be used in clinical settings. Several industry groups and providers are working to change this, though, arguing that wearables designed specifically for clinical purposes have the potential to be a vital part of the clinical research process, saving both time and money.
These are just a few of the technologies that are disrupting the clinical research process and shortening the time to market for new drugs. Cloud computing, artificial intelligence, and other emerging technologies are also having an impact, as will as-yet-undiscovered advances. However, experts warn that while the time to develop new treatments is getting shorter, that doesn’t mean that there will be “miracle cures” for common diseases discovered in mere months. The process of research still takes time, and there is still patient safety to consider. Still, it’s very likely that the time to market will soon average five to seven years or less, which is a major improvement, especially for those patients patiently waiting for new treatments.