Clinical Trial Designs

Clinical Trial Designs

Clinical trial designs vary considerably, impacting study execution, patient recruitment, endpoints, and treatment delivery. Here’s a brief summary of some common designs:  

First-In-Human (FIH) Studies

These are the initial human trials for a new drug, procedure, or treatment, focusing primarily on safety.  

Cohort Studies

These observational studies follow a group of individuals over an extended period to assess risk factors associated with developing specific conditions.  

Case-Control Studies

These studies compare individuals with a particular disease or condition (cases) to similar individuals without the disease (controls) to identify potential risk factors.  

Further reading on clinical trial design

Protocol design for clinical trials - the complete checklist

Protocol design for clinical trials - the complete checklist

Guest post by Youssef Soliman, medical student at Assiut University and biostatistician Designing a high-quality clinical trial protocol is critical for the success of any study. A protocol is the blueprint that outlines every aspect of a trial. In an ideal world, a flawless protocol would require no revisions and include only essential elements. In reality, however, the average protocol undergoes 2–3 amendments and often contains excessive data collection and overly complex entry criteria.

AI In clinical trials in 2025: the edge of tech

AI In clinical trials in 2025: the edge of tech

Clinical trials have long been the foundation of medical breakthroughs, but traditional methods often stumble over slow timelines, high costs, and difficulties in finding the right participants. Artificial intelligence (AI) — a technology ready to transform this landscape by making trials faster, more affordable, and smarter. The accelerating adoption of AI in clinical trials signals a major shift in healthcare research. It is already making significant strides in transforming clinical trials.

Feasibility process in in clinical trials - top best practices

Feasibility process in in clinical trials - top best practices

Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan In clinical trials, a staggering 80% encounter delays during the startup phase and 37% struggle to meet enrollment targets. Read more Key clinical trial statistics. These figures highlight a critical, yet often underemphasized, aspect of clinical trials—the feasibility process. The feasibility process is essential for assessing the practicality of a clinical trial’s design, ensuring the study is prepared to tackle the challenges that may arise.