Focus on Patients

1. 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.

2. 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.

3. 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.

4. 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.

5. Janssen’s Patient-centric Approach To Psychiatric Disease Management 11/10/2020

   Diseases as complex as those of the brain require an equally complex approach, centered on the unique needs, goals, and circumstances of the individual patients, as well as the loved ones who support them. Listening, empathizing, understanding — these basic human interactions will have a critical role in our ability to reach our goal and deliver transformational medical innovations.

6. Ensuring Patient-Friendly Clinical Trials For Complex Disorders — A Small Biopharma’s Playbook 10/22/2020

   Rezolute, a small company working in the rare pediatric disease space, is developing a new therapeutic option specifically for patients with congenital hyperinsulinism, an ultra-rare pediatric genetic disorder. Connecting and partnering with advocacy groups and physicians is paramount in the company's clinical trial execution. 

7. 4 Practical Ways To Improve The Patient Experience In Clinical Trials 10/13/2020

   Stakeholders have recognized the need for patients and advocates to have a seat at the table and be the central focus in enterprise approaches, commercialization, and research and development. How can we gather as much data in as few studies as possible? And in doing this, how can we acknowledge the impact that taking part in a trial has on the patients we are working to help?

8. 9 Factors For Driving Inclusivity & Patient Centricity In A Transformed Clinical Trials Landscape 9/15/2020

   Patient-centricity, quality, and inclusion are not natural consequences of the shift to virtual clinical trials. To be intentional with the design, we must start with articulating and understanding the full contexts of patients’ lives, medical and beyond.

9. 4 Best Practices That Kept A Biotech’s Clinical Trial Moving In The COVID-19 Era 8/12/2020

   The timely enrollment and progression of clinical trials is critical for a pre-commercial biotech company, as delays can keep treatments from getting to patients and cost an organization significant money and reputation. When you throw in a worldwide pandemic, it’s a whole new ball game.

10. Unpacking FDA’s New Guidance On Collecting Patient Experience Data 7/28/2020

    The FDA recently released one of what is to be four new guidances providing a general overview of patient-focused drug development. This article summarizes each component of "Guidance 1: Collecting Comprehensive and Representative Input" and details how the guidance may impact sponsors of clinical trials.