Everyone talks about new technologies flooding the clinical trials space – trendy tech that may or may not stick. But what about the other innovations in clinical trials primed to make a significant impact in the next 5 to 10 years?
Here’s where Firma sees the points of synergy – and leverage – for advancing clinical trials over the next 5 to 10 years. While these aren’t new trends, they are areas of industry focus or movement that show compelling promise.
Innovation in Clinical Trials Trend #1: Continued Healthcare & Research Unification
The line between healthcare and research is almost always in flux – CROs have invested in post-market research or sales and distribution for decades and sites often have both clinical and research arms–but the line has been increasingly blurring.
Healthcare companies are seeing revenue opportunities in the research space that are natural extensions of their services or technologies. Similarly, research companies have been much more open to moving into the healthcare arena if their technologies or service can be of use – something they’ve not historically expressed a great deal of interest in.
Point-of-care pharmacies and clinics in retail markets, typically there to address infectious disease or simple healthcare needs, are now recognized as a possible point of contact for researchers–a good way to engage with potential subjects, even providing protocol-specific support services for clinical trials. Walgreens, for example, has a long-standing tradition of working closely with pharmaceutical companies on everything from patient education to recruitment and data sharing. And CVS’s acquisition of Corem just five years ago signaled a tipping point expansion of retail healthcare well into the clinical trials space.
Additionally, more companies are arising that straddle the two worlds, providing innovative technologies and services that apply on both sides of the aisle.
While better recruitment and retention are two clear benefits, doctors and patients themselves are sure to benefit directly as well. The more centralized treatment protocols are for a patient whether they’re participating in a clinical trial or continuing care afterward, the better. And the more accessible we make all the resources, the quicker we can all help solve patients’ challenges.
Innovation in Clinical Trials Trend #2: Diversifying the Definition of Virtual Trials
A true virtual trial has traditionally meant one done without subjects, and there are companies that design trials using very complex disease models and algorithms. But today, everything from tech-enabled trials to those that ease patients’ travel burden in other ways are all being tagged as virtual trials.
While we’re not fans of using the term so broadly, it is consistent with how “virtual” is used in other areas of our lives – from the retail to the service industries and beyond. It has become shorthand for technology that makes life easier for a customer, and, in clinical trials, the patient is the customer.
Regardless of what one calls them, decentralized or tech-enabled trials are on the rise in a way that is consistent with how all of society is moving. Clinical trials that employ home visits, smartwatches or other telemetry platforms as part of the protocol design make it possible for patients to have their needs met throughout the study without leaving their homes, reducing the patient burden.
Likewise, we expect to see the industry continue to debate which term or terms are the most accurate. Categorizing the methods and services that enable less physical, in-person time and the technologies that make conducting a clinical trial easier for the patient won’t be easy, but it will be necessary for communicating value to the public.
Innovation in Clinical Trials Trend #3: Returns Outweigh the Risks
The clinical trials space will always be a risk-averse industry. When human lives are in the balance, how could we not be. Sponsors want to deploy innovation in clinical trials, but they are often slow to make changes simply because they need to be sure the return is strong and that the disruption to the trusted process won’t include unexpected, adverse outcomes.
In the last 5 to 10 years, however, CROs and sponsors have displayed a healthier appetite for taking on risk, increasing their investments in innovation, according to a recent industry survey. There is an urgent need for clinical trials to begin to mirror what patients see in other areas of their lives – ease of use and access to information – and the tipping point is here.
Telemetry, centralized data collection and manipulation, home visits, patient portals – anything that makes it easier to connect with and engage with patients, or easier for patients to participate in the first place – are getting more attention than they have in the past.
The impact of technology on reducing the patient burden is no longer in question. The challenge now is cutting through the noise. With so many different options when it comes to technologies and services, sponsors, sites and CROs are looking for compelling results that validate new innovations.