Ryan Jones is the cofounder and CEO of Florence Healthcare, a leading clinical trial software company.
If technology companies want to make a positive impact on healthcare, they need to explore ways to make clinical trials more accessible and efficient. Faster, more inclusive clinical trials lead to more effective, affordable medical treatments.
One of the largest obstacles to clinical trial efficiency is a lack of investigators, especially investigators from diverse backgrounds. This is a problem clinical trial technology vendors are uniquely equipped to solve.
Clinical trial software can give new investigators access to the training and infrastructure that they need to become successful long-term investigators. However, to make this a reality, we first need to understand the challenges new investigators face and how technology can help to overcome them.
An Emergency Shortage Of Clinical Trial Investigators
The number of clinical trials increased by 118% from 2010 to 2015 and by 80% from 2015 to 2020. Yet the pool of investigators hasn’t grown nearly that quickly. A study from the Tufts Center for Drug Development found that the global pool of clinical investigators only grew an average of 3.3% to 5.6% year over year.
The number of investigators doesn’t necessarily have to keep pace with the number of trials, since a single investigator can run more than one trial. But worryingly, clinical research also has a large number of “one-and-done” investigators who run only a single trial before leaving the field.
One study of worldwide investigators who registered trials with the FDA found that 49.6% of them participated in just one trial. That means we’re now facing an emergency shortage of research physicians.
Causes Of Investigator Shortages, And How Tech Can Help
Two of the most common reasons for clinical trial investigator shortages are:
• Lack of clinical research-specific training for physicians.
• Limited clinical research infrastructure.
These obstacles especially impact investigators at small community clinics or physicians’ offices. Large academic medical centers (AMCs) have experienced clinical research investigators on staff who can mentor less-experienced investigators and have technology infrastructure historically unavailable to small centers.
They also often have the human infrastructure—clinical research coordinators (CRCs) or regulatory coordinators to help with trial documentation.
But limiting clinical trials to major academic medical centers means only patients who live nearby or can afford to travel can reach those trials. That leads to a lack of diversity in clinical trial participants and investigators.
This is where technology comes in. Remote clinical trial software can connect academic medical centers or major pharmaceutical sponsors to community clinics or local physicians’ offices, allowing research expertise to bloom anywhere.
How Healthcare Tech Companies Can Design Tools To Bring In New Investigators
Clinical trial technology can bring new investigators into trials in two critical ways.
• Providing remote connections to training and mentorship.
• Offering access to resources from experienced research sites.
With technology’s ability to connect local physicians to large research sites, a larger, more diverse pool of physicians can become clinical research investigators.
Providing Remote Connections To Training And Mentorship
Many medical programs prepare students for patient care but not for clinical research. This means that physicians who want to become investigators need training on clinical research-specific regulations.
The Clinical Trials Transformation Initiative, a collaboration between Duke University and the FDA, urges academic medical centers and sponsors to use technology to solve this problem. With clinical trial software, they can seek out clinicians who work with underrepresented patients and offer them online clinical research training for free.
How can tech companies make this promise a reality? First, you need to let physicians and pharmacists at community clinics test and provide user feedback on the software you build—even if you need to provide that technology to them for free.
Second, you need to build databases that let physicians upload their credentials and sponsors instantly view those credentials. Comprehensive, physician-friendly matching technology for physicians and sponsors doesn’t exist yet, which means tech companies have the opportunity to create it.
Finally, tech vendors should consider building online clinical research training programs. If you can offer online training to physicians for free instead of relying solely on in-person training, you can prepare more highly qualified physicians to participate in clinical trials.
Offering Access To Resources From Experienced Research Sites
New investigators require resources to run clinical trials successfully. They need space to store trial supplies, help with documentation and regulatory staff, such as clinical research coordinators.
A hybrid clinical trial model, in which patients visit a local physician for check-ins and only go to a major academic medical center for more advanced scans or procedures, offers a solution to the problem of equipment storage.
Clinical trial software can also remove the need for rooms full of binders and paper documentation. Software should be designed that provides abundant storage space for clinical trial documents but also keeps those documents secure through features like user roles and permissions.
Technology can also connect AMCs to local physicians to run multisite trials. Tech companies can build remote connectivity software that lets AMCs and local physicians send each other documents, track one another’s edits and communicate instantly without violating health privacy laws.
If you want to make remote connectivity software a reality, though, you must be especially careful to add security features like redaction for protected health information (PHI) and audit trails that show who has edited documents and when. Features like these also make it easier for new investigators to follow clinical trial regulations, which are often intricate and intimidating.
Healthcare Tech Vendors Must Bring New Investigators Into Clinical Trials
Clinical trial technology often focuses on making workflows faster for existing clinical trial investigators. But with widespread investigator shortages and high turnover rates for new investigators, helping established investigators won’t be enough.
Clinical trial technology must connect investigators at major academic medical centers to physicians in local communities, including those who work at small offices and clinics. Through this process, software vendors can engage new, more diverse investigators—and more diverse patients—in potentially lifesaving clinical trials.