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.
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Introduction As we move toward 2025, clinical trial regulations are undergoing significant transformation. This shift is being fueled by technological advancements, changing healthcare needs, and an increasing emphasis on transparency and patient safety. In this post, we will explore the key clinical trial regulations shaping the clinical trial landscape, the challenges professionals face, and the strategies they must adopt to navigate this ever-evolving environment.
Thomas Wood has recently joined the Clinical Trial Files podcast with Karin Avila and Taymeyah Al-Toubah, discussing the inception of the Clinical Trial Risk Tool, what impact AI can make in clinical trials, and what Alan Turing would make of it all. This is an episode dedicated to Alan Turing’s 113th birthday on 23 June 2025. You can find the episode on Spotify Apple Podcasts Amazon Music Podcast Index Fountain Podcast Addict Podverse.
Guest post by Youssef Soliman, medical student at Assiut University and biostatistician Before launching a clinical study, even the most promising idea must be vetted for feasibility. In other words, can this trial be executed successfully in the real world? Feasibility assessments examine practical factors like available patients, site capabilities, timelines, and budget. This step is crucial. A majority of trials encounter delays or enrollment shortfalls (by some estimates, 70–80% of trials) [1], driving up costs and risking failure.
