Focus on Patients

1. 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.

2. 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.

3. 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.

4. 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.

5. 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?

6. 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.

7. 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.

8. Post-COVID-19 Clinical Trials: Finally Understanding The Meaning Of Patient-Centricity 5/27/2020

   Despite being instrumental to our mission of making lifesaving therapies accessible to all, patient perspectives are far too often lost in the wake of “flashier” news about COVID-19 therapy approvals, supply chains, and scientific breakthroughs.

9. How Do Underserved Communities Prefer To Learn About Clinical Research? 5/5/2020

   It is important to look at the big picture and better understand core participation motivators and barriers from the underrepresented patient’s perspective in order to better enable access to and increase their participation in clinical trials.

10. Developing A Clinical Trials Strategy For A Post-COVID World 5/4/2020

    It’s becoming clear that we need proactive, collaborative planning and execution to mitigate the impact we’ll absorb when the pandemic loosens its grip on our industry, along with a significant effort to advance our virtual capabilities forward.