Relationships in the Current Landscape
How important are relationships when it comes to efficiently managing clinical trials?
While Applied Clinical Trials covers many themes throughout the calendar year, it seems as if the common denominator is typically data. As I wrote in this space last month, our editor Andy Studna attended the 13th annual DPHARM: Disruptive Innovations to Modernize Clinical Research conference in Boston in September. Unsurprisingly, the main theme was innovations—specifically clinical trial solutions. Of course, there were many such innovations on display that focused on data collection. How does all of this data-talk fit into our November issue, which focuses on contract research organization (CRO) and sponsor relationships? In the new world order of multiple vendors in the clinical trials space, there are more solutions available, more methods of collecting data; more of everything it seems. How are CROs and sponsors handling all of this and how are they keeping the quality of data in check? That's the prevailing question we explore in this issue.
Speaking of collecting data, Studna recently returned from Barcelona, Spain, where he covered the SCOPE Europe conference. Coverage, including video footage of a panel he moderated on electronic clinical outcome assessment, can be found on our conference coverage page.
The first of our November feature articles focuses on new CRO/sponsor partnership and outsourcing models that have gained popularity in recent years. These arrangements have added even more complexity to what I mentioned above. To tackle these dynamics, CROs and sponsors are creating strategic relationships that emphasize a shared partnership culture and operational strategy. The article explores approaches in managing these partnerships. Our next feature also examines this relationship evolution, but provides a unique cautionary look at the 11 key "warning signs" to watch for that could impact CRO/sponsor success. Rounding out our trio of November features on this theme is an article on streamlining clinical trials. With all of the new challenges CROs and sponsors are facing, service providers can step in to help with the goal of creating efficient and more patient-focused trials.
Thank you for reading.
Mike Hennessy Jr, President and CEO, MJH Life Sciences®
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
