The rise of digital technology solutions has had a significant impact on every industry, and pharma is no exception. Even if you feel like you’re a bit behind, you’ve heard how new solutions like this are being used to improve recruitment and engagement rates in clinical trials while reducing associated costs in the process.
These solutions come with a broad spectrum of benefits, including:
- Greater engagement & adherence statistics
- Improved recruitment
- Reduced costs
- Better data
Not to mention that technologies such as adherence trackers and other mHealth applications have the potential to hugely benefit users. However, progress doesn’t typically come without challenges, and the digital revolution is no exception. As we move forward with apps, mHealth, big data, and more, our industry must find solutions to myriad issues.
Leveraging Patient-Generated Data
The increased prevalence of virtual clinical trials will lead to an increasingly complex variety of patient-generated data. The question is how does the pharma industry leverage this type of data?
In the past, we’ve relied solely or heavily on observer-reported data supplied by researchers, and sometimes used patient reported data as a supplement– especially as the push for patient centricity grew stronger.
A study published last year in the Journal of Clinical Oncology found that only three of the forty cancer drugs approved between January 2010 and December 2014 included patient-reported outcomes (PRO) information in the drug insert.
Oncology drugs are an exceptionally low example of PRO inclusion percentage; however, a mere 24% of non-oncology treatments that were found to include patient-reported information over the same time period.
Though they do encourage it, the FDA does not require pharmaceutical companies to include PROs. So in a way, we’re still figuring out how to treat patient-reported data, let alone the much newer topic of patient generated data.
One challenge pharma will face is learning how to make better use of this relatively new option. We cannot, of course, approach patient-generated data like we do observer-reported data. Moreover, we should not repeat some of the same mistakes we’ve made with patient-reported data, such as under-utilizing it.
While clinical trials may accurately assess a drug or treatment’s efficacy at treating a disease, they often fail to take into account the patient’s experience when participating in a clinical trial. Gaining a better understanding for the patient’s experience, and working to improve that from the design phase on, is key to making significant improvements in clinical trials. This will in turn lead to better recruitment and retention rates.
Employing the Right Talent
With new technological capabilities comes the need for fitting human talent. And in the grey realm where digital, medical, and big data overlap, this can be hard to achieve.
“There really aren’t enough well-trained people who understand how to deal with big data problems,” said Steve Labkoff, executive director, medical affairs strategy, at Purdue Pharma and a fellow of the American College of Medical Informatics, in a recent interview with Pharm Exec.
Big data is a relatively new concept, and often those working within pharma simply don’t know the ropes. After all, it isn’t their area of expertise.
Similarly, someone better qualified to handle big data may lack other necessary skills. A statistical analyst, for example, may not know enough about medicine to make a given judgement call.
“Unfortunately it often takes the critical eye of a physician to judge whether there is a credible level of evidence for an app or whether it is just a bunch of hocus pocus,” David M. Levine, M.D., primary care physician and researcher at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, MA, said to Medical News Today.
There are a lot of human talents that must grow in order to utilize today’s technological capabilities. Whether it’s the need for more people with crossover skill-sets or whether pharma must internally step up its data analysis and tech game, there is no question that we must somehow expand our limits. Formerly clinical researchers only needed to sufficiently analyze small amounts of clinical trial data, but now they need to be able to gain insights from the vast amount of real-world data.
Since we’ve seen an explosion in the amount of data that far surpasses the confines of our traditional, tightly controlled clinical trial bubbles, we have to make sure our talent is growing with it.
It’s nearly impossible to talk about the digital revolution without touching on all of the inevitable security concerns. Health organizations still remain one of the top targets for hackers. The wealth of valuable, private knowledge kept within any kind of health-related business’ system will likely remain a sought-after goldmine for generations of internet criminals to come.
Here are some things that will likely happen in the next few years:
- Ransomware threats will continue to grow
- Medical devices will have inevitable vulnerabilities exposed
- Hiring security workers will remain a challenge
- Shortages of potential hirees are reported in all industries
- Insiders will also pose a growing security risk
- Mobile devices and any tech involved in bring your own device (BYOD) clinical trials will challenge providers’ security
- The more data providers share, more risks there will be
Technological growth is a double edged sword of sorts. While it gives us the power to explore previously inconceivable ideas, it also endangers us to a new level of security risks.
Not only are large hospitals, research centers, and any type of business in the medical field at risk, but individuals are at risk too. Most people go about their everyday lives letting their phones track their steps, entering calorie counts into apps, tracking their sleep, and even monitoring their fertility without stopping to question into whose hands they are actually entrusting this data, or who could potentially hack into it.
Greater Need for Integration
Speaking of entering countless pieces of information into countless apps, this poses problems other than just security. Another challenge lies in the fact that there are tons of different health tools, and far too few actually connect with one another. Currently, most apps create their own platform with unique log-ins and of course, their own security issues.
This makes interoperability–devices, apps, and other systems exchanging data and subsequently interpreting the shared data–next to impossible. Connectivity promises to be a big issue for the future unless things change.
Considering all these different programs are owned by different people and companies, have different goals, and may have entirely different operating systems, there would be a lot of collaboration required for us to make headway on this topic. However, integration of new technologies will be extremely important in the future.
Dr. Levine expressed his desires as a physician: “We want it to all be visible to our entire health team so that anyone can log into it and it is all in one place.”
As more apps and software systems are developed to handle various aspects of a study, the need for seamless integration will become essential to success, not just for physicians, but for all of us.
Slow Downs Due to Regulatory Constraints
Unfortunately, the desire to innovate and develop new tech solutions often outpaces the more practical need to ensure that proper regulatory standards are upheld. For example, the once best-selling mHealth app Instant Blood Pressure (IBP) was taken out of app stores last year because of its dangerous levels of inaccuracy. Recently, the fertility app Glow apologized for levels of security so low that supposedly even someone with almost no knowledge of hacking could have broken in.
This tech revolution is moving fast and with it comes a slew of new regulatory constraints. Though these are needed, they represent a challenge that could limit acceptable applications in future clinical trials.
The FTC recently released a tool in conjunction with the FDA and others which aids developers and sponsors in figuring out which laws and regulations will apply to their device, mHealth app, or other technology. The FDA also has a section on mobile medical applications which details what kinds of health apps they cover.
Here’s what the FDA has to say about technological progress in clinical trials:
“Clinical investigations that ensure the protection of the rights, safety, and welfare of trial participants and that yield reliable data are critical to FDA’s mission to ensure that medical products are safe and effective. Creative uses of technology in conducting clinical investigations have emerged over the previous decade and include advances that have the potential to improve recruitment, participation, and retention of trial participants,” wrote Associate Commissioner for Policy Leslie Kux.
So while the FDA endorses the use of digital technologies in clinical trials, they obviously plan to closely oversee and regulate it as well.
The saying that “nothing worth having comes easily” could certainly be applied to the tech revolution’s role in pharma. Though technology and medicine should theoretically progress together, it takes some time and problem solving to make sure the former does indeed allow the latter to advance.
There will be plenty of challenges and speed bumps along the way, but ultimately new technology will revolutionize every aspect of our industry; letting us develop more effective medications at a faster rate and for significantly less money.
Welcome to Clinical Research Trends, a new blog dedicated to providing breaking news on clinical trial recruitment, patient engagement, new technology and noteworthy trends. With this blog, we are working to provide clinical research organizations, sponsors and leading service providers with critical news and industry updates on a regular basis. If you want to learn more about the latest trends in clinical trial recruitment and drug development, you’ve come to the right place.