Whether the headlines are about artificial intelligence or big data, the clinical research industry is undergoing significant change. Many sponsor organizations and CROs have begun their digital revolution, with others trying to catch up. The effect of this change is being felt by patients, of course, set to gain from greater efficiencies, improved data and increased access to treatment.
But the workforce is under pressure to adapt to the technological changes. In this post we explore how the clinical trial workforce is changing across the globe and the value that digital natives can bring to the industry.
In about 20 years from now, the National Health Service in the UK will require the overwhelming majority of its workforce to have some tech skills. Indeed, Dr. Eric Topol, founder and director of the Scripps Research Translational Institute, says as many as 90 percent of NHS jobs will have digital and genomics literacy requirement in order to deal with a data-driven healthcare environment.
A digital-savvy workforce is required to satisfy patient health and well-being demands, which will be more frequently be delivered through technological applications. Topol says the demand for digital skills will be positive as there will be new career opportunities in healthcare. The focus for professionals in the industry should be on developing skills in provenance, curation and governance of data.
What’s required of clinical research professionals today is vastly different from the past. The new world is digital, says Dr. Rob Scott, chief medical officer at biopharmaceutical company AbbVie. Plus, the pace of change is fast and speeding up.
An example of this is Abbvie’s design lab, which has a database of 14,000 clinical trials and 32 million patients, as well as real-world data from electronic medical records of hundreds of millions of patients. He calls the room, with touchpad screens on the walls, “The Minority Report” of clinical trial design as it allows researchers to predict the future with greater accuracy.
Scott refers to a quote he keeps on his whiteboard: “You can’t do today’s job with yesterday’s methods and be successful tomorrow.” It’s up to digital savvy professionals to deliver tomorrow’s methods for future success.
Clinical professionals can gain the skills to become proficient in their role but new technology and tools can shift these experts into the role of novices multiple times in their career. The idea of moving from knowledgeable worker to novice is important to consider when analyzing hiring trends in the sector, Stephen A. Sonstein and Carolynn T. Jones write at Frontiers in Pharmacology.
For instance, roles are increasingly complex and employers assume that those with the most experience will be best-suited to them. The result is that many highly educated but newly qualified professionals struggle to break into the employment market. This is despite development over the past decade of academic programs by which physician investigators, clinical research staff (coordinators, trial monitors and data managers) and regulatory affairs professionals are trained and educated.
In this period of rapid change, Sonstein and Jones caution employers not to equate experience with competence, and to look for qualified young professionals to fill these increasingly digitally focused roles.
Risk-based monitoring means more site investigators are monitoring trial processes remotely. The appeal of this approach is two-pronged: reduced site visits and cost savings. But the job requirement has changed as a result. Clinical research coordinators need to have a strong math background in order to analyze data effectively, explains Jim Kremidas, executive director of the Association of Clinical Research Professionals.
Equally, CRCs will need to focus on quality assurance and be able to oversee data. Kremidas envisions a technology specialist patients can contact for assistance in digital trial processes.
The clinical research industry lacks computational skills and the advent of AI-enabled processes will further expose this shortage. Even those already tasked with data analysis will have to acquire new tech skills with the arrival of new tools such as genomics, digital medicine, AI and robotics, says Dr. Gabriella Rustici, associate director of training at Health Data Research UK.
To plug the skills gap, HDR is collaborating with the Software Sustainability Institute and with ELIXIR, a life science infrastructure for biological information. Through intensive and practical workshops, researchers and scientists can acquire and improve crucial computing and data skills.
The significant increase in the amount of clinical data has given researchers the potential for far better insights. Consider the example from Marie McCarthy and Chen Admanti, from ICON and Intel respectively. In a typical phase II clinical trial for the central nervous system with under 100 participating for a few months to a year, researchers might want patients to use a wearable with a 50Hz accelerometer and gyroscope sensors. That one device would generate some one billion data points a day.
There would also likely be other data sets such as heart and respiration rates, resulting in complex data sets. Clinical professionals able to maximize the value of high frequency data sets will need to be data scientists who are experts in advanced analytics.
Large data sets through a big data or real-world evidence (RWE) approach to clinical research will require clinical research staff adept at dealing with streams of data in a dynamic way. This means the industry will likely see more clinical data scientist roles, writes Francis Kendall, senior director of biostatistics and programming at biometrics contract research organization Cytel.
Current trials require data to be checked rigorously and the role of clinical data management teams in pharmaceutical companies is to do just that. However, Kendall says big data or RWE will mean there are more missing data points and that standards of data collection will differ.
He argues that machine learning technologies will help overcome the challenges of data quality and data noise. The problem is that current clinical data scientists are not sufficiently skilled to maximize the data. Kendall thinks the solution may well be seeing how health data is used outside the life science industry. For instance, looking at how data from health apps and devices such as diabetes-monitoring apps or ECG-measuring apps is managed and analyzed will inform which skills are necessary for clinical data scientists.
Digital natives who are highly skilled in data analysis and digital processes will undoubtedly be in demand in the clinical research industry. But communication skills will always be required for successful clinical research associates, notes recruiter Kate Keller.
A CRA is one member of the clinical trial team that still has to travel a great deal. They also comb datasets for any problems, submit field reports and meet many people. All of that means CRAs need to be excellent at time management and adept at mastering different electronic data capture systems. And they also need to be able to have potentially difficult conversations with different types of people, Keller adds.
The industry is buzzing with future-focused ideals including big data and collaborative partnerships. And these are important to pursue. However, industry employers will need to keep their employees in mind when doing so, says David Humphreys, global head of health policy at The Economist Intelligence Unit.
Aiming for the great technological progress of the future is important but so too is ensuring that the employers give staff the resources to upskill and harness the power of new digital tools.
Patients want data and it is the responsibility of sponsors — and to their advantage — to ensure those demands are granted. Delivering data is an essential part of the trial process, says Tom O’Leary, chief information officer at clinical research organization Icon.
Yet pharma companies are not the only players that have seen the importance of data delivery. Telecom companies are entering the healthcare space to provide patients with data about diseases and indications as well as to fulfill the role of a healthcare companion.
O’Leary that his own company has undergone an 18-month-long digital transformation to use data and other technology in a more sophisticated manner. The CRO now communicates and collaborates with pharma, biotech and medical device companies by providing video, chat and data sharing tools under its digital offering.
This will likely be the route that many other CROs take. Digital natives will be well-placed to provide the skill sets needed for these transformations.
Change has historically been quite slow in clinical research. With so much at stake, innovating processes and methods can seem risky. However, migrating to a fully technology-enabled system will happen with the generational change of the industry’s professionals, explain Tristan Allen and Diane Bell at Digital Health.
This new system will focus on providing solutions to cater to actual rather than perceived needs of patients. The patients will be empowered and skeptical of medical opinions, choosing value-based delivery of their healthcare.
In an industry evolving through technological innovation, digital natives will be adept at navigating these changes. Those that can learn quickly, adapt their skill sets and understand the true power of data will drive the industry forward. Yet soft people skills will always remain an important skill set for clinical trial professionals to hone.
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