This post originally appeared on Fast Data Science’s blog on LinkedIn.
Clinical research can be better understood through two primary perspectives: the anatomy and physiology of a study. These themes help researchers design and conduct efficient and valid studies.
The anatomy of research encompasses the tangible elements of a study plan. A protocol lays out these elements, serving as a detailed blueprint for the study. The main components of this blueprint include:
Research Question: The core objective or the specific uncertainty the study aims to resolve. It often begins with a broad concern narrowed down to a concrete, researchable issue. For example:
Background and Significance: Conduct a thorough literature review to understand what is already known about the topic. It helps refine the research question and establish the study’s rationale by identifying gaps in existing knowledge.
Design: The study’s structure includes decisions about whether to conduct an intervention or an observational study. Different designs suit different research questions and resources. For example:
Participants: Criteria for selecting study participants and the sampling design.
Variables: Defining predictor variables, confounding variables, and outcome variables, which are the measurements to be made during the study.
Statistical Issues include formulating hypotheses, determining sample size, and deciding on the analytic approach.
The physiology of research focuses on the processes that make the study work and how to ensure these processes yield valid conclusions. The aim is to minimise errors that could compromise the study’s findings and applicability to the larger population.
Design studies to yield reliable results about what happened within the research and how to generalize those results. It involves rigorous data collection, accurate measurement techniques, and appropriate statistical analysis to ensure that conclusions are valid and actionable.
While separating the anatomy and physiology of research helps simplify complex topics, it is essential to understand that these components are interdependent. Just as in the human body, the anatomy of a research study (its structure) and its physiology (how it functions) must work together seamlessly to produce meaningful and reliable results.
Understanding both the anatomy and physiology of clinical research is crucial for designing studies that are efficient, valid, and capable of providing significant insights. By meticulously planning the study’s structure and ensuring the processes are robust, researchers can achieve reliable and applicable findings to broader contexts.
Fast Data Science has created a Clinical Trial Risk Tool that uses AI to help you derive cost and risk estimates from clinical documents. Try the Clinical Trial Risk Tool here: https://mailchi.mp/fastdatascience/clinicaltrialrisktool
Source:
Browner, Warren, S. et al. Designing Clinical Research. Available from: Wolters Kluwer, (5th Edition). Wolters Kluwer Health, 2022.
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Guest post by Youssef Soliman, medical student at Assiut University and biostatistician In 2025, the outsourcing of clinical trials has become a common strategy for pharmaceutical and biotechnology sponsors. Facing rising R&D costs and complicated studies, sponsors turn to Contract Research Organizations (CROs) and other external partners to manage clinical trials. This practice, known as outsourcing clinical trials, is adopted as a best practice for containing costs and enhancing efficiency in drug development [1].
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.
