Clinical Guest Contributors

  1. 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.

  2. 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. 

  3. 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.

  4. 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?

  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. Increasing Diversity In Clinical Trials: The Critical Role Of Community Partnerships & Collaborations 10/6/2020

    Meaningful long-term engagement, collaborations, and partnerships — rather than those based on specific trial or project needs — deepen community relationships, build trust, gain an understanding of community priorities, and make research programs more responsive to the needs, values, and perspectives of the affected populations. 

  7. Capacity & Competency Of The Clinical Research Workforce — Today & Tomorrow 9/29/2020

    It’s not simply an issue of supply and demand. It’s closer to life and death. Put bluntly, we may not be able to keep up with future clinical trial demand because our workforce isn’t growing fast enough. In fact, by some metrics, we’re already falling behind.

  8. COVID-19’s Impact On The Clinical Trial Ancillary Supplies Industry 9/24/2020

    With restrictions on logistics, and countries implementing new restrictions to address increasing COVID-19 cases, it’s important to understand how to manage clinical trials’ ancillary supplies — like sourcing from the right suppliers, managing distribution to all trial sites, stock management, and response to new regulations.

  9. Safeguarding Participant Data During Risk-based Monitoring — Practical Considerations 9/22/2020

    With risk-based monitoring becoming more common, and with sponsor/CRO monitors reviewing electronic source data remotely, many questions have arisen regarding what security measures need to be in place to ensure the protection of study participants’ data.

  10. Can Virtual Trials Maintain Their Momentum After COVID? 9/17/2020

    Prior to COVID-19, there were many discussions about how it might be possible to conduct virtual trials, using technology and innovative measures. Now that the pandemic has forced many trials into virtual settings, what will it take for the industry to fully implement a virtual approach beyond the pandemic?