Clinical trial designs vary considerably, impacting study execution, patient recruitment, endpoints, and treatment delivery. Here’s a brief summary of some common designs:
These are the initial human trials for a new drug, procedure, or treatment, focusing primarily on safety.
These observational studies follow a group of individuals over an extended period to assess risk factors associated with developing specific conditions.
These studies compare individuals with a particular disease or condition (cases) to similar individuals without the disease (controls) to identify potential risk factors.
Creating clinical trial budgets from protocols Creating a clinical trial budget is a fiddly and time consuming process. The playbook for running the clinical trial is a document called the protocol. You can find examples of protocols here. The protocol states how many participants will take part in the trial and also what visits and procedures will take place. Above: a protocol. Source: NCT04128579 A clinical trial manager must read the protocol and look for all pieces of information in the protocol that is relevant to the budget, in particular the Schedule of Events (also called Schedule of Assessments or Schedule of Activities), which is a table or series of tables which indicate which procedures and assessments will take place on which the visits.
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.
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.
