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.
The Importance Of Accurate Cost Estimation In Clinical Trials
Optimise Your Clinical Trial Workflow Then Save Time And Money
You may have been tasked with creating a clinical trial site budget. This is a budget itemising all the costs that will be incurred at the study site. The site budget may be needed To estimate the total cost of that site running part of the trial, as part of a bid to the CRO or sponsor To identify who needs to be reimbursed for each cost item To ascertain whether or not it is feasible to run the trial at that site To ensure that the site is reimbursed for the costs that they incur while running the trial If you are building a site budget, the most important document is the study protocol.
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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. Upload your clinical trial protocol and create a cost benchmark with AI Protocol to cost benchmark The Clinical Trial Risk Tool uses AI and Natural Language Processing (NLP) to estimate the cost of a trial using the information contained in the clinical trial protocol.
