The Pluses and Minuses of Innovation
Applied Clinical Trials
Survey delves deep into what constitutes true game-changing innovation in clinical development.
There is hype. And there is innovation. There are expectations and reality. While the chart below is from our latest survey conducted with SCORR Marketing on innovation, this question itself doesn’t use the “i” word. Something that has the “potential to change the future of clinical trials” should be considered an innovation, but of the five choices we gave, which is a true innovation? And does it matter if it indeed changes the future?
The survey delved much deeper into what respondents think about innovation, what types of innovation is or is not being implemented, and how innovation is viewed by stakeholders. These results can be download for free here.
Other items of note from the survey include the majority of respondents feel that CROs are most accepting of innovative processes, while clinical sites are not; an equal number of companies have or don’t have an innovations department or infrastructure (43.4%); and the most often cited reason for hindering adoption of technological advances is cost.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
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.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
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.
