Focus on Patients

1. 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. 

2. 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?

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 6 Practical Ways To Increase Diversity In Clinical Trials 6/11/2020

   Even when a certain disease is more prevalent in a particular minority population, it can still be difficult for trial investigators to reach the right individuals. As an industry — as a group of researchers dedicating our lives to improve the health of others, regardless of their race, age, gender, or disease — how can we do better?

9. Inside Novo Nordisk’s Patient Advisory Board Meetings 6/2/2020

   Novo Nordisk's first DEEP (Disease Experience Expert People) Advisory Board meeting brought together leaders of patient organizations, patient advocates, and patients from five countries to participate in a dialogue with the company's Global Patient Relations team, project vice presidents, medical specialists, and trial managers.

10. What Patients Are Telling Sites About Trial Participation During COVID-19 5/28/2020

    LMC Manna conducted interviews with patients who are currently enrolled in a Phase 3 clinical trial at one of their sites, with questions focusing on the impact of COVID-19 during their trial participation. Here's what they had to say.