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

Updates to the Clinical Trial Risk Tool

Updates to the Clinical Trial Risk Tool

We have improved the Clinical Trial Risk Tool in the last 6 months, making it more user friendly and taking on board the feedback that we’ve received. We’ve improved the accuracy of the machine learning components too. The tool now outputs its key figures such as risk levels and estimated cost in easily readable cards, so you can see at a glance the key takeaways from your protocol: The risk factors are now organised into collapsible categories, so you can explore them easily without an information overload.

Clinical trial team structure and best practices

Clinical trial team structure and best practices

Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Introduction The success of a clinical trial is strongly dependent on the structure and coordination of the teams managing it. Given the high stakes and significant impact of every decision made during the trial, it is essential for each team member to collaborate efficiently in order to meet strict deadlines, comply with regulations, and ensure reliable results.

How to read and extract value from a clinical trial protocol

How to read and extract value from a clinical trial protocol

Guest post by Youssef Soliman, medical student at Assiut University and biostatistician Clinical trial protocols are detailed master-plans of a study – often 100–200 pages long – outlining objectives, design, procedures, eligibility and analysis. Reading them cover-to-cover can be daunting and time-consuming. Yet careful review is essential. Protocols are the “backbone” of good research, ensuring trials are safe for participants and scientifically valid [1]. Fortunately, there are systematic strategies to speed up review and keep it objective.