Focus on Patients

1. 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.

2. 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.

3. 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.

4. 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. 

5. 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?

6. 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.

7. 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.

8. 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.

9. Searching For Clinical Trials: How Can We Improve The Patient Experience? 7/21/2020

   While adherence to ClinicalTrials.gov guidance is not optimal, the bigger issue is the widespread absence of patient focus in most brief titles and brief summaries.

10. How Trial Sites & Sponsors Can Deliver On Patient Convenience In The Age Of COVID-19 6/16/2020

    For insights on the impact of COVID-19 on patient convenience in clinical studies, and how sites and sponsors should respond, Clinical Leader reached out to Allyson Small, chief operating officer of the Society for Clinical Research Sites (SCRS) and a nearly 20-year-veteran of the healthcare industry.