Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority
Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority. However, suboptimal adherence is prevalent in ambulatory trials, in which outpatients are responsible for taking the drug according to the protocol-specified dosing regimen. Unfortunately, most methods for measuring medication adherence are inaccurate, which can result in costly phase III failures. This whitepaper focuses on a proven exception-automatic adherence measurement through electronic compilation of drug dosing histories. Electronic measurement enables a better understanding of drug safety and efficacy data, improving the likelihood of a successful trial outcome and more informed development decisions, leading to faster speed to commercialization.
Read more on our whitepaper here.
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.