Diversity in Clinical Trials: Diminishing Barriers to Participation
"Science for a Better Life" can touch everyone!

Diversity in Clinical Trials: Diminishing Barriers to Participation

Bayer’s vision of, “Health for all, Hunger for none”, is committed to inclusiveness in our clinical trials by addressing the needs of all patients. Under Research and Development, Clinical Operations (CO) looks at ways to diminish barriers in people’s lives, so they can participate in a Bayer study. Offering efficient and flexible means to participate will allow for better diversification numbers in our enrollment efforts. For instance, patient centricity can enable study teams to provide a working mother greater access to a new investigational treatment with telehealth capability right in her own home. 

Bias in clinical trials can hinder progress in drug development and the discovery of cutting-edge therapeutics. At Bayer, we focus on adapting innovative solutions that help prevent systemic bias. The traditional clinical trial can be inconvenient for the participant. Modern technology is changing this mindset by allowing the Investigator to incorporate nondisruptive solutions that can better accommodate the lives of individuals and their families.

The Impact Digitalization brings to Patient Engagement

Bayer clinical trials are facilitating change that helps address the growing demand of an evolving patient population in research. The following digital components are playing a key role in amplifying a greater demographic group in Bayer trials:

1) Telehealth

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Telehealth is a game changer when it comes to extending the patient reach by allowing long-distance contact between a patient and the clinician. Electronic information and telecommunication technologies can make participating in Bayer trials more accessible to a diverse population group. Doctor visits via video are convenient offerings for people who live in rural communities and patients with travel limitations. For instance, travel can be difficult for patients who need wheelchair assistance; therefore, telehealth opportunities can make it easier throughout the trial duration.

2) Home Nursing

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Modernizing the traditional clinical trial model enables nurses to perform study related procedures at the patient’s home. Home nursing allows Bayer to bring the trial to the patient with tools and technology that administer treatments and monitor outcomes. Wearable health technology with remote data collection creates convenience and reliability for the patient and the study team. Home nursing can entice a higher recruitment rate in larger and harder-to-reach population groups by reducing the burden of traveling to the site and saving the patient time and money.

3) Direct-to-Patient Shipment

Direct-to-patient (DTP) shipment addresses clinical trial logistics challenges. DTP provides an opportunity for patients to receive Investigational Medicinal Product (IMP) at home, which adds to the convenience factor of participating in a Bayer study. This allows the Investigator oversight of dispensing drugs and is a time saver for the patient; they don’t have to travel to the site for this step.

4) Trial e-Consent Form

Bayer has simplified the patient agreement process by implementing an electronic consent submission that is easily accessible from any location. Clinical trial e-Consent is an online, digital consent that all potential study participants complete prior to enrollment, then use throughout the study duration. Transforming the traditional paper consent form into an engaging digital experience is allowing Bayer studies to better support a more diverse population group. E-Consent consists of multiple electronic media devices to convey information related to the study. Options such as text, graphics, videos, and audio features can assist people with various physical and learning disabilities.

5) Concierge Transportation Service Exploration

Transportation factors can be a major barrier to both participation and retention in clinical trials. Digital ride sharing networks can be easily accessed from a smart phone or a tablet to arrange patient transfers to sites. Patient concierge services are being explored by Bayer as another means to ease the burden on patients and expand accessibility of our clinical trials to all. Currently, Bayer already offers direct patient reimbursement solutions so that patients can be immediately reimbursed for costs associated with their participation in a clinical trial.

6) Social Media Campaign Consideration

Using social media to communicate with potential patients can be extremely effective in targeting specific demographics needed for a trial. Facebook alone has over two billion users. Utilizing social media platforms and search engine tools can offer study teams the opportunity to target members in specific geographic locations, ethnic groups, and with certain health conditions that are needed to conduct an inclusive trial. Evaluating the effectiveness of paid ad campaigns is also currently being considered by Bayer.

7) Local Screening Event Affiliates

Bayer is planning to partner with a company that runs local health screenings in large populated areas. A mobile healthcare truck travels to organized spots, such as cities and shopping centers, to facilitate community screenings for clinical trials. Offering alternative logistical options can reach potential participants that do not go online or use social media. Digital technology permits information to be collected on the road and results transferred back to Bayer quickly. This option can also bring more diversity in Bayer trials.

“Science for a Better Life" should be Accessible and Convenient for Everyone

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The digital age is allowing us to test boundaries and transform the way we look at the future of clinical trials. Enrolling a diverse pool of patients is often a challenge. We seek to bring better awareness to upcoming Bayer trials and eliminate obstacles that get in the way of participating. Fortunately, modern technology can help us be better patient focused by adapting trials that fit the lifestyles and needs of people.

Our team in operations is taking a holistic view of how Bayer and our partners approach clinical trials. Digital technology and innovative ways of working can significantly improve diversity and inclusiveness in our research. A better patient experience can reduce barriers for different population groups needed to make sure our products are safer and more effective for everyone.

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About Bayer CDO

Clinical Development Operations (CDO) is the operational driver of Bayer Pharma’s Research & Development organization. The CDO group consists of 1800+ industry experts. CDO strives to put patients' needs and safety first by adapting cutting edge approaches to clinical trials. We are focused on modernized advancements and automation technology. These are the building blocks behind “Science for a Better Life.” 

Our goal is to improve the science behind generating quality data, delivering efficient clinical trials, and finding innovative talent. And CDO, through the science, is taking large steps toward Bayer’s vision of “Health for all, Hunger for none.”

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Recent article published by Bayer CDO:

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Published on May 11, 2021, by Joachim Luithle, Head of Clinical Development Operations (CDO), Bayer

‘All Roads Lead to and from Rome’ or Better Yet, Health for All!

Published on April 29, 2021, by Donna Libretti Cooke,  Director, Contracting & Budgeting, Clinical Development Operations (CDO), Bayer

Josh Kravitz

President & Co-Founder of Extra Good, LLC

2y

Thanks for sharing these important thoughts.

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Carly Santer, PhD FRSA

Strategic Initiatives Project Leader & Sustainability Activator (Global Clinical Development & Operations, Bayer) // Climate Concerned Pragmatic Optimist, Forensic Long Term Systems Thinker, Storytelling Sustainabologist

2y

Joachim - your article provides more great examples of sustainability in CDO. It’s exciting that opportunities continue to be identified to broaden access to healthcare through clinical trials.

Max Wegner

SVP Head Regulatory Affairs bei Bayer AG

2y

Very nice article Joachim capturing important aspects of todays clinical trials! Well done !

Janice Chang

CEO I Leading with Curiosity and Purpose I Committed to Drive Meaningful Change for Patients

2y

Diversity in clinical trials is a priority for all of us, as professionals in this ecosystem. Everyone has a role to play.

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