Clinical Guest Contributors

11. Starting A Career In Clinical Research: 7 Things We Wish We Knew 11/24/2020

    The clinical research industry is facing a talent shortage that could become acute in the next decade. A main contributor to this shortage is a lack of focused intervention at every level to identify the skills, behaviors, and knowledge that will enable motivated candidates to begin and mature their careers in the industry. 

12. New Approaches In Patient Tracking For The Rare Disease Sector 11/17/2020

    While we have seen exponential growth in the effort to develop drugs to treat rare diseases in the 30 years since the Orphan Drug Act was introduced, unique challenges remain. Awareness of rare diseases is often low among stakeholders including physicians, healthcare providers, payers, and even patients themselves; trial protocols and regulatory pathways may be unclear, especially for investigational rare disease drugs that are first-in-class; and data on disease incidence, onset, progression, and burden are often limited.

13. 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.

14. Pandemic Accelerates Expanding Role Of Real-World Evidence In FDA Medical Device Submissions 11/4/2020

    By forcing the FDA to become comfortable with the use of real-world data in order to authorize COVID-19 diagnostic tests, the pandemic may have unintentionally forced the agency to reflect in a more pragmatic way on what characteristics of real-world evidence (RWE) it believes are essential for data integrity and what level of uncertainty it can tolerate in connection with RWE.

15. How EMD Serono Is Bringing Diverse Patient Voices Together 11/3/2020

    The pandemic has created an opportunity to address some of the causes underlying clinical care inequities. And while combatting these issues will take time, much can be done by first addressing the gap for minorities in clinical trials. This is a topic I am passionate about both personally and professionally as a female Hispanic chief medical officer.

16. Are You At Risk For An FDA ClinicalTrials.gov-Related Monetary Penalty? 10/27/2020

    The FDA has historically not initiated formal actions to enforce the statutory requirements to register and provide clinical trial data to the ClinicalTrials.gov data bank. However, industry is now on notice that the FDA is about to change its approach.

17. 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. 

18. 3 Steps To Get A Virtual Clinical Trial Up And Running 10/20/2020

    Despite the existence of innovative technologies, they are only one piece of a complicated puzzle needed to successfully implement virtual clinical trial models. It’s critical that sponsors also consider these three key steps for achieving sustainable change in the bold, patient-centric move to virtual clinical trials.

19. How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data 10/14/2020

    Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

20. 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?