Focus on Patients

1. Co-Creating With Patients: The New Guide To Expanded Access 10/12/2021

   Recently, Janssen Pharmaceutical Companies had the privilege of working with patients and advocacy groups to co-create a resource about expanded access for patients and caregivers. This article shares that story and describes how patients will benefit from the resource.

2. What Can Clinical Leaders Do To Tackle The Global Women’s Health Gap? 9/9/2021

   Nearly 300,000 women die every year from preventable causes related to pregnancy and childbirth. Postpartum hemorrhage is the leading cause of maternal death globally — and in the US, it's on the rise. Uterine fibroids disproportionately impact Black women and are a leading cause of hysterectomies. We must drive a concerted, ecosystem-wide effort that scales up clinical research for women.

3. Incorporating Patient Voice In Rare Disease Trials: 3 Lessons Learned 9/7/2021

   As the rare disease market has expanded, being a patient-centered company has become a necessity as much as an aspiration. When we involve patients early on in our drug development programs, we get valuable insights and can understand their special situations, which helps us design the most effective solutions that meet their needs. Here are my three lessons learned.

4. Tackling Health Misinformation Among Hispanics For Better Clinical Research & Patient Data 8/31/2021

   For years, Hispanic communities have faced inequities in many aspects of healthcare — from finding health education, being health literate, accessing healthcare, and underrepresentation in clinical research. This article discusses CreakyJoints' efforts in tackling this health misinformation.

5. 2 Key Ways To Improve Patient Recruitment Of Minorities In Clinical Trials – A Participant’s Perspective 6/1/2021

   John A. Reaves was compelled to participate in clinical trials for a COVID-19 vaccine. In this article, he discusses his experience and provides two recommendations, including potential strategies for accomplishing them, for how the industry can improve recruitment of minorities for clinical trials.

6. Best Practices For Designing And Running Clinical Trials For Patients With Rare Diseases 5/25/2021

   As an industry, we are constantly searching for ways to improve the drug development process – particularly in the rare disease space. One way to improve on running your rare disease clinical trial is to foster collaborative partnerships with patient advocacy organizations and to stay connected to patients throughout the trial. Here's how to do that.

7. FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch 3/19/2021

   The FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment. These five key elements deserve our attention.

8. Incorporating The Voices Of Parents And Children In Pediatric Clinical Trials 3/9/2021

   Pediatric trials are far more complex than simply evaluating a therapy in the context of a child’s disease or illness. They are a family affair that must accommodate the diverse needs of parents and other family members caring for those children. This article discusses recent survey findings from the Center for Information and Study on Clinical Research Participation.

9. Best Practices For Implementing Decentralized Clinical Trials 1/12/2021

   While the experience design related to the patient is paramount to the adoption of decentralized clinical trial technology, the interrelated experience and incentives for all stakeholders must be fully aligned to realize the full benefits of these platforms.

10. Lessons For Leaders: The Loud And Lasting Impact Of COVID-19 On The Future Of Clinical Research 12/15/2020

    Last year, shortly before the pandemic, we predicted that clinical trials of the future would be more open, more human-centered, and more integrated in the healthcare ecosystem, providing guideposts for how industry will adapt along these three themes. COVID-19 has both accelerated these trends and highlighted new challenges for R&D leaders to address.