2011 Diversity Conference by Oregon Department of Transportation is licensed under CC by 2.0
Failing to recruit a diverse population of patients for clinical trials can have a negative impact on drug research. Last year, Lilly CEO John Lechleiter pointed out in a Forbes editorial that “when clinical trials are skewed toward Caucasians, researchers can miss key interactions between the drug and genes.” It’s unfortunate to think that we may be missing opportunities to create more effective treatments due to these gaps in knowledge and understanding.
National Minority Health Month and National Minority Cancer Awareness Week, observed each year in April, were created to address the issues preventing minorities from having full access to healthcare options. Among the many health-related disparities that minorities face are fewer opportunities to learn about and enroll in clinical research studies. This disparity is most pronounced in the area of cancer.
Lilly employee Coleman Gerstner presents a concept for improving adherence at the Adherence Summit.
The following post is by Ken Savin, Advisor, Clinical Innovation at Eli Lilly and Company. Ken received his Ph.D. from the University of Utah in 1996 and came to Lilly in 1998 from the Memorial Sloan Kettering Cancer Research Center as a senior organic chemist. He worked on several projects as a medicinal chemist in the areas of anxiety, depression and inflammatory disorders, and he has been involved in many cross-functional Lilly research collaborations. Some of Ken’s recent efforts include the NASA – Lilly collaboration, an outgrowth of the InnoCentive program and a recent Innovation Day event. Through these programs, he continues to reach out to other organizations internally and externally as part of a broader open innovation effort.
Every day we see some evidence that the culture of medicine is changing. Paternalistic approaches to providing healthcare are becoming less and less acceptable as patients have begun to make good use of the medical information and community support networks available on the Internet. If we, as drug developers, want to provide the best possible care and the best possible medicines, it just makes good sense for us to listen to people and carefully consider what works best from their standpoint.
Adherence, the idea of whether or not a patient is following a treatment regimen as directed, is one of many complex issues within drug development for which we could use more insights from patients and caregivers. It has been estimated that three out of four Americans do not take their medications as prescribed. Even in clinical trials, where adherence rates tend to be relatively high, investigators report average adherence rates of only 43 to 78 percent among patients receiving treatment for chronic conditions. This can lead to poor health outcomes for patients, and unreliable results in a clinical trial.
In the early 90s, Britt Johnson‘s life was like that of any healthy young girl. Until suddenly, it wasn’t. In the summer of 1992, Britt came down with strep throat for the first of what would be many times. Over the next several months, Britt encountered one health setback after another. Months of health setbacks turned into years, during which time Britt had repeated contact with the healthcare system. This contact was not always positive. Britt received a series of misdiagnoses and was even accused of being a hypochondriac. Finally, at the age of 20 Britt was diagnosed with Psoriatic Arthritis. Britt’s disease has continued to progress, and her diagnosis has been amended to Spondyloarthropathy and Rheumatoid Arthritis.
Clinical research site professionals (investigators, site directors, study coordinators, and pharmacists) play a very important role in shaping a clinical trial volunteer’s experience. That role can be a complex one, as they work to build bridges between the sponsor’s goals for a trial, the physician’s care plan for the volunteer, and the volunteer’s own needs and wishes. They are often “the face” of the trial, and provide the much-needed personal connection for patients as they navigate the process of participating in a trial.
We know there’s a lot we can learn from their experiences and insights. We recently created a Lilly Innovation Site Advocacy Group to help keep the lines of communication open and encourage innovative thinking around improving the clinical trial experience. Our hope is that we can make site professionals jobs a little easier, and offer exceptional trial experiences for patients.