Biswas, D., Pechmann, C., 2011. What do these clinical trial results mean? How product efficacy judgments are affected by data partitioning, framing, and quantification. Organizational Behavior and Human Decision Processes. 117: 341-350.
Does the study pay its volunteers? What will I experience? How will my safety be assured if I participate? Will I receive the results of the trial? Under informed consent, participants can ask questions before, during, and after the trial. Clinical trials are categorized as Phase I to IV...
how you interpret the results of a Phase 2 trial depends on whether it was mainly intended to quantify the effect size, figure out the best way to design the upcoming pivotal trial, establish how the drug looks versus
Survodutide (BI 456906) is a GLP-1/glucagon co-agonist which has progressed to phase 3 clinical trials as treatment for obesity (SYNCHRONIZE programme). In a recently completed phase 2 trial (abstract data), 46 weeks of survodutide once weekly (0.6 to 4.8 mg) resulted in a dose-dependen...
Approval for Wegovy in children was supported by the 68-week Phase 3a STEP TEENS clinical trial with 201 adolescents aged 12 years or older. Wegovy was superior to placebo in mean percent change in BMI at week 68 (16.1% decrease vs 0.6% increase) - the primary endpoint. In addition, the...
What does “resectable” mean? What’s the difference between “early-stage” and “resectable” NSCLC? What are the most important things I should know about NSCLC that can be removed by surgery? What’s the difference between “early-stage” and “resectable” NSCLC?
I really liked that trial design. Another trial that is ongoing that I think should be a model is the imetelstat trial; it's a prospective randomized phase 3 trial. The primary endpoint is overall survival. That's a black-and-white endpoint. There's no wiggle room there. If patients ...
However, the most important efficacy endpoint, protection against severe disease and death, is difficult to assess in phase 3 clinical trials. In this Review, we explore the challenges in assessing the efficacy of candidate SARS-CoV-2 vaccines, discuss the caveats needed to interpret reported ...
When we tracked the number of assets transitioning to Phase I, Phase II, and Phase III clinical trials, we found that Phase I and Phase II assets have transitioned 50 percent faster since 2018 than between 2013 and 2018, whereas Phase III assets have maintained much the same pace...
Pre-registration also encompasses other types of registrations, like protocol registration or clinical trial registration. All of these registrations essentially mean documenting a plan before a study is conducted, for clarity and to avoid any QRP allegations or issues later. This pre-registration proces...