Bayer’s efforts to make the charitable donation of unused trial kits and supplies an industrywide practice earned it the top spot at the inaugural WCG Innovation Challenge held at the MAGI Clinical Research Conference West in Las Vegas, Nev., last week.

Research professionals in attendance, who were asked to judge five clinical research innovations, were most impressed by Bayer’s successful implementation of the Kits4Life program, an initiative that’s aimed at ending two long-time problems: the disposal of leftover lab kits and supplies from U.S. trials, and the scarcity of such supplies in underdeveloped and disaster-impacted areas.

Kits4Life was launched in 2020 through a collaborative effort that included the nonprofit MedSurplus Alliance, accredited medical surplus recovery groups and other sponsors. Bayer was the first sponsor to successfully adopt the important program at an organizationwide level and did so in just 10 months.

Bayer has integrated the program in all of its U.S. trials and has achieved resounding success with sites, says Donna Libretti Cooke, director of contracting and budgeting for Bayer and the chair of onboarding workstream for Kits4Life’s advisory council.

The results from Bayer’s pilot program have been impressive, Libretti Cooke explained during her presentation: Across 44 U.S. trials and more than 205 sites, more than 6,000 lab kits and trial items, such as urine test analyzers and collection cups, specimen containers, diabetic socks, lancing devices and pedometers, have been donated to humanitarian causes through June this year.

Sites have been enthusiastic about the program because it makes it easy for them to donate rather than destroy supplies, which can take hours, she said. All donating requires of sites is completing a five-minute (or less) form, putting the kits in a box and shipping them to the designated medical surplus recovery organization, which handles the rest.

Bayer is so invested in this effort that it has put out a comprehensive onboarding toolkit to help other sponsors implement the program. The toolkit offers sponsors an array of resources they can use to make the implementation and approval process easier, including:

• An introductory slide deck about the program;
• An implementation guide;
• An FAQ document;
• A template agreement for engaging with nonprofits;
• A blueprint for assembling a business case;
• Sponsor communication recommendations; and
• Recommended authorization language for clinical trial agreements.

The toolkit also includes training slides for CRAs, quick site instructions and slides explaining the donation process.

Starting out, Libretti Cooke said she experienced bumps in the road to corporate buy-in and advised other sponsors to be prepared to face potential legal hurdles as well.

“Working with corporate donations was brand new for somebody in clinical operations, something we’ve never ever done before, and that was a learning curve, definitely,” she said.

Kits4Life has seen real success in its two years, providing items to community health centers in Kenya, supplies to Tanzania, and hurricane and earthquake relief to Haiti, Puerto Rico and the Bahamas. Libretti Cooke’s vision for the future of the program is ambitious: The finish line looks to be making the donation of unused trial supplies an established industry best practice that routinely occurs when trials wrap up. Those involved in the program are currently working to expand it outside the U.S. and are in discussions with multiple CROs to bring them into the fold.

The Rest of the Best

In addition to Bayer, four other innovative efforts were chosen as finalists out of a pool of 35 submitted innovations. Following is a summary of each finalist’s program.

Boston Children’s Hospital’s Intern-to-Full-time Employee Pathway

Brandi Bratrude, program administration manager of hematology/oncology at Boston Children’s Hospital (BCH), presented her site’s innovative pipeline for developing high school and college interns into full-time employees.

The project, designed in collaboration with the Workforce Development office at Dana-Farber Cancer Institute, kicked off in 2020 when BCH made it a priority to diversify its clinical research team racially and ethnically. One to three interns per academic term are assigned standard responsibilities to bring them quickly into the mix as integral staff and are involved in day-to-day research tasks, including study screening, patient consenting, sample coordination and data collection, Bratrude said. The program provides mentors and trainers and allows interns to shadow various jobs, from research coordinators to physicians.

Feedback from both staff and intern participants has been universally positive, she said. BCH has hired three interns into full-time positions so far.

Sanofi’s Patient-Informed Clinical Development Model

Paul Cox, Health Value Translation Lead for Sanofi, presented the drugmaker’s innovative approach to incorporating the voice of the patient through direct collaboration with patient advisors, advocacy groups and caregivers around the globe and across the full length of its drug development process.

Sanofi has embarked on multiple endeavors related to patient-centricity in the past; this innovation “involves bringing them all together,” Cox explained during his presentation. The initiative includes specific therapeutic areas, convening patient panels, tapping into social media and close contact with patient advocates and advocacy groups. Sanofi also makes it a point to provide site training materials that are particularly centered around trust and trustworthiness, essential factors in connecting with underserved and underrepresented groups and communities.

As a result of pursuing patient feedback as early as possible, Cox said that Sanofi has managed to reduce its protocols by three procedures on average.

Temple University’s System for Training Researchers on Clinical Care

Hannah Reimer, a clinical research nurse for Temple University, shared her site’s effective approach to including researchers in the clinical care of patients. The efforts have translated into greater compliance with standard-of-care targeted temperature management (TTM), as well as increased enrollment in a TTM trial, she said.

Specifically, Reimer and her fellow researchers took action to bring the institution’s clinical care, clinical research and support staff together and bridge an existing hierarchy that had them working separately but in the same space. By working with the Quality Improvement department, her team identified areas where research and clinical needs crossed, became content experts on standard-of-care and equipment, and made changes happen.

“We challenged the idea of working separately,” she said. “We worked together to make sure the patient gets the best care. We challenged the idea that research is separate from and holds no benefit for a patient’s clinical care or the institution’s clinical goals.”

St. Lawrence Health’s Innovative Overhaul of Its Hiring and Interview Process

Kylie Sands, a clinical research associate for St. Lawrence Health System, a group of three small sites in northern New York, outlined her site’s approach to interviewing research staff candidates to assess their soft skills and technical abilities.

As part of St. Lawrence Health’s approach, all candidates are tasked with a prescreening activity and given 10 minutes to complete it. The exercise is essentially an exam on a fake rheumatoid arthritis trial, during which candidates are given the inclusion/exclusion criteria and a list of eight fictional potential participants to evaluate.

The purpose is not so much to see if they answer correctly, she said. The intention is to assess candidates’ communication and critical thinking skills as well as see how they respond to being corrected. Getting a look at how potential hires are likely to act on the job has been invaluable. “We are able to gain a lot of insight as far as how they handle themselves and whether they’re willing to admit if they made mistakes,” she said.

The new approach has led to the hiring of multiple dedicated and talented research/nurse coordinators and interns, and staff quality and retention has improved noticeably, according to Sands. So far, two interns have joined her site, four have received research positions outside St. Lawrence after graduation and two have moved on to medical school.

Watch video of the winners discussing their projects at https://bit.ly/3eQdm2f.