By Allison Proffitt

September 14, 2021 | Later this month, ClinOne will announce a new technology platform specifically for oncology clinical trials, bringing together its solutions for peer referrals, eConsent, video visits, Uber Health, and patient empowerment into a single platform. ClinOne has gathered insights into the unique challenges of oncology trials; nearly half of the trials ClinOne has worked on with sponsors and CROs have been oncology trials. The company hopes the oncology tool bundle will apply those learnings to help patients and families connect with their research sites and manage their experiences, inside and outside of the trial.

“While each of our modules has been used individually for years, with this specialized turnkey package we have made it as easy as possible for sponsors, CROs, and sites to instantly elevate how they connect with new patients, inform them about the trial, and empower them to take control of their research experience and clinical care,” said Rob Bohacs, ClinOne Founder and Chief Solutions Officer.

The ClinOne for Oncology solution combines tools for peer referrals, eConsent, video visits, Uber Health, and patient empowerment. Optional additions to ClinOne for Oncology include a self-dosing compliance manager (frequently used for background pain medications) and eDiaries for quality-of-life questionnaires increasingly used in labeling decisions. All solutions are part of in ClinOne’s true single platform which features BYOD capabilities, cost-accessible pricing, and deployment in weeks, not months.

Clinical Research News reached out to Bohacs and asked about the need he saw for this platform of tools and how they’ll be able to help.

Clinical Research News: In your experience, why are oncology trials unique? 

Rob Bohacs: Before starting ClinOne, I ran an oncology site network and CRO, so I saw firsthand the challenges faced by not only patients, but also their caregivers and family members, not to mention site staff and study teams trying to navigate these complex studies. And when my own mother was diagnosed with breast cancer, I experienced many of those same challenges and sometimes feeling helpless. I can't even begin imagine how families manage it without someone on the inside of the industry.  

There are some sobering statistics out there, starting with 39.5% of us will get cancer in our lifetime. Now factor costs in excess of $100k USD or more per clinical trial patient, increasingly complex protocols, and restrictive inclusion/exclusion criteria as drugs become targeted, and you see why oncology trials demand special attention and extra care. 

Oncology research has evolved from observational to chemotherapy infusion to targeted oral medication and now to cell therapy—each with its own nuances and requirements. Many sites today, for example, are not fully equipped to run cell therapy studies which feature a few extended visits, background medication adherence, a complex consent process, and extended follow-up to monitor the risk of therapy rejection. Chemo, on the other hand, requires frequent visits (and reliable transportation options), management of significant side effects, and quality of life assessments. Both have significant caregiver involvement.  

That's why we can't treat any one oncology trial the same as any other, and with its high average cost per patient, we need to support sites, patients, caregivers, and family members to ease the burden and ensure success. 

Why does this patient population need a custom set of tools? 

Nearly half of all the trials we support are in oncology, so we know patients need specialized care and attention to enable their participation. We are passionate about helping to Connect, Inform, and Empower patients—and their care team, families, and loved ones—throughout the process. What do we mean by that?

Connect: It is becoming harder and harder to navigate the clinical trial landscape, and with everything else going on in a patient's life when they get a cancer diagnosis, wading through clinicaltrials.gov is not something most people are able to do. We try to bring appropriate trials to their oncologist's attention by reaching out with study info and encouraging referrals to actively enrolling local study sites.  

Inform: Oncology trials are notorious for having multiple types of consent forms and many amendments for re-consenting throughout the trial. It can be a nightmare for sites to manage, and typically leads to numerous audit findings that delay the trial. eConsent simplifies the process for sites, eliminates human error, and most importantly brings patients, caregivers, HCPs, oncologists, and site staff together for important conversations to truly educate them on risks, benefits, and requirements to make more informed participation decisions. 

Empower: Cancer patients lead full and busy lives and deserve technology that supports them without getting in their way. Consider, for example, a transfusion therapy that prohibits a cancer patient from driving for some time after. We've worked with sponsors to integrate Uber Health into the patient portal so not only can they arrange reliable transportation to and from the site visit (or the site staff can do it for them) but also to the grocery store or to visit their family on the weekend. Similarly, interactive SMS messages sent to/from their personal phone can remind them and confirm that they are taking background pain medications. Video visit platforms that can accommodate more than just the patient lets them bring loved ones and other medical advisors up to speed with trial activities. 

No one participates in a trial alone, and no one fights cancer alone. That's why technology that brings patients, family, and care teams together—along with exciting new treatments—is so critical right now. Tools like these are easy to implement and help cancer patients, who often have no choice other than to participate as a care option, find and succeed in clinical trials.