This post originally appeared on Fast Data Science’s blog on LinkedIn.
A well-constructed study plan is the backbone of any clinical research project. It guides the research process and ensures that the study is feasible, ethical, and capable of generating valid results. Here’s a step-by-step guide to developing an effective study plan.
The core of your study plan is the research question. It must be specific and significant and address an unresolved issue. For example, “Can we diminish loneliness among the elderly by providing a structured in-home support program?” This question is precise and has direct implications for improving patient care.
Could you conduct a thorough literature review to understand what is already known?
Define the significance of the research question and its potential impact on clinical practice or public health.
2. Study Design:
Choose between observational and clinical trials based on the research question and available resources.
Consider various designs, such as cross-sectional, cohort, or case-control studies for observational research and randomised controlled intervention trials.
3. Participants:
Define explicit inclusion and exclusion criteria to ensure a representative sample.
Estimate the required sample size early to avoid feasibility issues later.
4. Variables:
Clearly define predictor, confounding, and outcome variables.
Ensure these variables are measurable and relevant to the research question.
5. Statistical Issues:
Formulate hypotheses and determine the appropriate statistical methods.
Plan for data analysis to ensure the results are valid and reliable.
Expertise in your study area is crucial. Keep abreast of recent advances and engage with the scientific community through:
Systematic literature reviews.
Participation in scientific meetings and conferences.
Building relationships with other experts in the field.
Ethical standards are paramount in clinical research. Ensure your study:
Obtains informed consent from participants.
Maintains participant confidentiality.
Receives approval from relevant ethical committees.
Throughout the study, remain open to new ideas and improvements:
Attend conferences and engage in informal discussions with peers.
Be receptive to feedback and willing to refine your study plan as necessary.
Developing a robust study plan involves meticulous preparation and continuous learning. By focusing on a well-defined research question and adhering to ethical standards, you can ensure that your clinical research will be feasible, impactful, and valuable to the scientific community.
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#ClinicalResearch #StudyDesign #MedicalScience #ResearchEthics
Source:
Browner, Warren, S. et al. Designing Clinical Research. Available from: Wolters Kluwer, (5th Edition). Wolters Kluwer Health, 2022.
Browner, Warren, S. et al. Designing Clinical Research. Available from: Wolters Kluwer, (5th Edition). Wolters Kluwer Health, 2022.
Introduction People have asked us often, how was the Clinical Trial Risk Tool trained? Does it just throw documents into ChatGPT? Or conversely, is it just an expert system, where we have painstakingly crafted keyword matching rules to look for important snippets of information in unstructured documents? Most of the tool is built using machine learning techniques. We either hand-annotated training data, or took training data from public sources. How We Trained the Models inside the Clinical Trial Risk Tool The different models inside the Clinical Trial Risk tool have been trained on real data, mostly taken from clinical trial repositories such as clinicaltrials.
Over the years, the overall cost of the drug development process has been exponentially increasing, prompting the adoption and use of adaptive clinical trial design software. Though there are practical difficulties and barriers in implementing clinical trial solutions, these problems are adequately addressed to overcome these issues as they arise. With advancements in software technologies, further improvements are being made to the software’s adaptive clinical trial design. Despite these progresses, just only a handful of well-established software with various types of clinical trial adaptations is currently available.
A clinical trial protocol is a document which serves as the step-by-step playbook for running the trial. The clinical trial protocol guides the study researchers to run the clinical trial effectively within a stipulated period. The prime focus of the clinical trial protocol is to ensure patients’ safety and data security. [1, 2] As the clinical trial protocol is an essential document for the seamless execution of the clinical trial, reviewing (peer-reviewing) the protocol is essential to ensure the scientific validity/viability/quality of the protocol.
