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.
Estimating the total cost of a clinical trial before it runs is challenging. Public data on past trial costs can be hard to come by, as many companies guard this information carefully. Trials in high income countries and low and middle income countries have very different costs. Clinical trial costs are not normally distributed.[1] I took a dataset of just over 10,000 US-funded trials. You can see that the range is huge, from small device or behavioural trials costing as little as $50,000, while large multi-centre international trials can cost hundreds of millions.
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Introduction The success of clinical studies relies heavily on proper financial planning and budgeting. These processes directly impact key factors such as project timelines, resource allocation, and compliance with regulatory requirements. The accurate forecasting of costs for clinical trials, however, is a highly complex and resource-intensive process. A study by the Tufts Center for the Study of Drug Development found that the average cost of developing a new drug is approximately $2.
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Introduction Recent years have seen a substantial rise in oncology clinical trials, with annual growth exceeding 260 studies on average [1]. Despite this increase, these studies continue to be some of the most demanding and resource-intensive in clinical research. The combination of intensive monitoring, detailed assessment schedules, and highly specific eligibility criteria creates substantial operational challenges.
