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Bringing the Human Side Back to Clinical Research on Clinical Trials Day

Intro

The first recorded clinical trial took place on May 20th, 1747, on a ship patrolling the English Channel. You may have heard of it—James Lind established what is believed to be the first randomized, controlled trial to find a cure for scurvy. Lind’s study actually resulted in a cure incredibly quickly, an immediate pay off that is unheard of in today’s clinical trials.

Lind’s successful investigation is what all researchers aspire for, but with new technologies and more complex data collection, researchers are often left without a direct return from their research efforts. The work of clinical research, while invaluable, is lengthy, often taxing and full of ups and downs. To celebrate the work of James Lind and those who’ve followed in his footsteps, we wanted to remind our research community why we do what we do.

Planting Seeds for Future Research

There is an old proverb that says, “The true meaning of life is to plant trees under whose shade you do not expect to sit.”

In an industry where researchers often work years, even decades, towards a medical breakthrough, this proverb is particularly suitable. How do you keep your eyes on a healthier future when the day-to-day tasks and struggles obstruct your vision?

We spoke with three Medrians, Melissa Newara, Tina Caruana and Alanah Nowotarski, who have prior experience working for research sites, operating as a sponsor, and participating as a patient, to understand what keeps them working towards a healthier future.

What motivated you to get into clinical research in the first place?

Alanah had participated in several clinical trials before she began working at Medrio and continues to participate in clinical trials due to a personal health condition.

Of her most recent experience, where Alanah wore an EEG reader, she said, “The device trials were super interesting to me and gave me hope that technology was being developed that could help my condition. I have an interest in clinical research and what they do, and how they can bring technologies and pharmaceuticals to the market. If I can be a part of helping that come to fruition, why not?”

“I fell in love with the process of research and meeting research participants,” says Tina Caruana, who has worked with sponsor organizations for over two decades and began her career in clinical trials in a hospital research department while in college.

For Melissa, who has been in research since 2004, she emphasized her desire to see humanity brought back into the clinical trial industry. “We all have loved ones who are impacted and need treatment. We’re all in this together.”

Walk us through the typical trial experience. What workflows or technologies did you experience?

Alanah’s most recent experience as a participant in a clinical trial was for a medical device. Alanah explained that there were 3 – 4 in-clinic visits to gather her consent and baseline data before she took the device home. She was then directed to use the device for an hour a day, six days a week for twelve weeks. Alanah went into the clinic about once a month for those twelve weeks as she used the device at home.

According to a 2021 McKinsey patient survey, more than 60% of consumers expect to be able to check medical records, test results, renew medication, and schedule healthcare appointments online. With the desire for remote telehealth growing among patients and consumers, how is the clinical trial industry adapting to this influx of technology?

In Tina’s experience, she’s worked with digital solutions such as electronic data capture (EDC), IVRS—now more commonly referred to as randomization and trial supply management (RTSM)— clinical trial management solutions (CTMS), and electronic reported outcomes (ePRO). “When I started my career, nearly all trial data was collected on paper.”

The paper process Tina experienced first hand felt “cumbersome”. Tina said, “Having seen this evolution to eClinical technologies, it’s really impacting how we can get products to market faster and speed up clinical development time.”

When expressing some of the challenges that paper processes produced, Melissa mentioned a backlog in data entry and query requests, as well as, late patient diary entries. “All the issues we talk about with paper-based collection I’ve seen in real life and it’s challenging. It’s a lot of effort to get the same amount of data in, and I think because of that, data quality can suffer.”

Tina recalls having stacks of case report forms (CRFs) and subject diaries piled on her desk that needed to be shipped out to sites for completion. “Ultimately, all that [data] had to be double-entered into the database. Queries were generated, then query responses would go back and forth between the sites and data management until finally we could say we had a clean database and could lock it.”

Melissa continued, “I’ve worked in large health systems who had just started integrating EMRs across their organizations, so there is a learning curve and grumblings of how fast and easy it is just to do it on paper. But I think with all technologies, once people get over the learning curve, they can start to see the value add of the technology.”

How does your previous experience help your role at Medrio?

Having been a participant in clinical trials before, Alanah has a unique perspective on Medrio’s products and approach to clinical trial technology. When brainstorming new ideas for Medrio’s eConsent product, for example, she says, “Every day I’m thinking, ‘Oh, how was my experience consenting? Where did I have challenges understanding how the research could potentially benefit me, or the risks I could potentially take on?’ How can I make that more digestible or understandable [for our participants]?”

In Tina’s time before Medrio, she had experience working with Medrio EDC as a sponsor. Tina shared, “Now that I’m at Medrio it’s valuable to have had that exposure to shape how I appreciate the other products we have within our portfolio. It’s interesting to be on this side of the fence now and helping to develop and promote the other products within the larger Medrio ecosystem.”

How can the clinical trials community help bring the human-side back to trials?

“If you can help add to the knowledge of your condition, not only you but others can benefit from it as well,” said Alanah, when asked if she would recommend others to participate in a clinical trial.

The reason Tina has continued her career in clinical trials is, “The work of clinical research itself. Helping patients and hopefully bringing new therapeutics and maybe life-saving devices or medications to the market. It’s meaningful work and very rewarding.”

Melissa said, “You’re working with somebody who can be in a very fragile mindset, and their families are overwhelmed. Making it as easy as possible to participate, whether that means remotely, electronic capture so they don’t have to mail their papers back, if you can eliminate those ‘just one more’ things, you’re making it easy for someone to engage and that’s at the site-level and at the patient-level.”

Conclusion

There isn’t an instant pay off for clinical trials and it can be hard to see the trees in the distance, but they’re there. And we’re here to help make it a little easier to get to our healthier future. Our fully integrated eClinical suite is designed for you, whether you’re a patient, a researcher, or a stakeholder.

Our solutions aim to make it easier for all of those involved in the clinical trial process. See how our EDC, RTSM, eConsent, ePRO and other solutions can bring back the human side of clinical trials and help you reach that future a little quicker.



1 https://www.clinicaltrialsday.org/about

2 https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/the-next-frontier-of-care-delivery-in-healthcare#patient

Contributors

Melissa Newara
Sr. Director, Subject Matter Expertise at Medrio Former experience: Clinical Research Sites
Alanah Nowotarski
Product Analyst at Medrio Former experience: Clinical Trial Patient
Tina Carauana, SME Medrio eClinical Solutions
Tina Caruana
Subject Matter Expert at Medrio Former experience: Biopharmaceutical Sponsor