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Discovery & Development Clinical Trials, Technology and Equipment

Clinical Trials 4.0

As Chief Product Officer at Advarra, Elisa Cascade is responsible for driving technology product vision and management. The company recently expanded its clinical trial platform Longboat to accelerate study activation and to enhance site performance through a single site command center. Longboat now features an online patient portal with engagement tools that enable information sharing between patients, sites, and sponsors or CROs without adding technology burden. Here, Cascade tells us how digitalization is transforming the clinical research process.

How does the improved functionality benefit patients? 

Patient centricity remains key to successful healthcare services and clinical research. Stakeholders prefer engagement and positive patient experiences to form part of the fabric of the process. If we continue to overlook the investigators and other site staff who provide care during studies, a great deal of hard work and investment will come to nought. Longboat’s key features include its ability for physicians to share consent forms and lab results with patients, who can then access these, as well as other important files in one place. 

Patient participation in a clinical trial can be burdensome because of the need for time off work and being away from home with minimal (if any) compensation. As has been highlighted in numerous articles, including recent TransCelerate feedback, providing patients access to their own data helps them integrate a clinical trial into their lives by supporting their own understanding of their healthcare status, as well as supporting communication with family and other healthcare providers. 

How does it bring benefits to the researchers and clinicians? 

Because the patient portal module is part of the same platform the clinical research site uses for essential document collection, training/learning management, study conduct enablement tools, and safety letter viewing and acknowledgement, sites can provide a more engaging, connected experience. Sponsors and CROs can send a newsletter to patients, and the site is informed of the content of these communications. This is critically important because if the patient has any questions they will contact the site, not the sponsor or the CRO, for answers. 

I also hope that platforms like this can help improve patient enrollment, which is an ongoing challenge for the industry. Specifically, pre-trial disease, study, and informed consent education supports increased enrollment, while the education, document sharing, and links to other study tools promote greater patient retention. 

Why are patients today so interested in their own treatment data?

The trends in patient empowerment in clinical research parallel overall market trends in patients taking control over their own health conditions. This trend certainly has been enabled through access to healthcare information on the internet, coupled with the meaningful use provisions (now referred to as programs promoting interoperability) put in place by the Center for Medicaid and Medicare services in the US. Although patient empowerment and access to treatment data has increased, use of technology to engage patients in clinical research lags behind other industries, including banking and finance, shopping, and transportation.   

Give us a bold prediction on the future of clinical trials 20 years from now…

Comparing my Blackberry of 20 years ago to my iPhone of today, it’s hard to imagine what the world will look like in 2043 in any aspect, let alone clinical research! However, I believe (and sincerely hope) that healthcare providers and clinical research sites will remain intimately involved in clinical research. There may be new care models with optionality in care delivery for some patients, but sites will still be an integral part of the clinical research process.  

Second, patients will be much more empowered with transparent access to their own healthcare information. Ideally (and maybe thinking wishfully), patients will be so well informed that clinical research will truly become a care option that is offered as part of all treatment pathways (not just oncology or rare diseases).  

The endgame will be to realize new treatment options, faster. It’s hard to argue against the two key principles of keeping the patient informed pre-, during, and post-study, and simplifying the site experience, which is critical in sustaining the clinical trial workforce as well as enabling sites to focus on what matters most – the patient. 

Connectivity provides visibility while preserving relationships. Transparency and collaboration in real time will be a big win for everyone involved.

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