This post originally appeared on Fast Data Science’s blog on LinkedIn.
In clinical research, the journey from a compelling idea to a well-executed study begins with crafting a robust research question and developing a meticulous study plan. This process ensures the study’s feasibility, ethical integrity, and potential impact.
Here’s how to transform your research ideas into actionable study plans.
A research question is the keystone of any clinical study, representing the specific uncertainty the investigator aims to resolve. For instance, among older adults, understanding if structured in-home support can diminish loneliness and prevent functional decline leads to actionable questions such as:
Can structured in-home support programs reduce loneliness among older people?
What types of interventions (peer, family, or group support) are most effective?
Can these programs be effective if conducted remotely?
To define a good research question, ensure it is:
Feasible: Can it be practically studied with available resources?
Important: Does it address a significant issue in the field?
Novel: Does it offer new insights or challenge existing beliefs?
Ethical: Can it be conducted ethically, with necessary approvals?
Experienced researchers often draw questions from previous studies, while new investigators can look to existing literature and clinical experiences for inspiration. Reflect on:
Studies that have intrigued you.
Clinical cases where outcomes could be improved.
Current practices that might be questioned or refined.
Becoming an expert in your chosen field is essential for developing strong research questions and study plans. Engage in continuous learning by:
Conducting systematic literature reviews.
Attending scientific meetings and conferences.
Building relationships with experts and following thought leaders.
Staying updated with resources like ClinicalTrials.gov and Prospero.
Once you have a solid research question, the next step is to develop a comprehensive study plan. Key components include:
Background and Significance:
Conduct a thorough literature review to establish the context and importance of your research question.
Highlight the potential impact of your study on clinical practice or public health.
Study Design:
Based on the research question and resources (e.g., observational, clinical trial), choose the appropriate study design.
Consider cross-sectional, cohort, or case-control designs for observational studies and randomized controlled intervention trials.
Participant Selection:
Define inclusion and exclusion criteria to ensure a representative sample.
Estimate the necessary sample size to achieve reliable results.
Variables and Measurements:
Clearly define predictor, confounding, and outcome variables.
Ensure these variables are measurable and relevant to the research question.
Statistical Analysis:
Formulate hypotheses and select appropriate statistical methods.
Plan data analysis to ensure valid and reliable results.
Ethical standards are paramount in clinical research. Ensure your study:
Obtains informed consent from participants.
Maintains participant confidentiality.
Receives approval from ethical committees and adheres to regulatory guidelines.
Creativity and collaboration play critical roles in refining research ideas. Engage with colleagues, attend conferences, and remain open to new technologies and methodologies. For example, technological advances in genetic, molecular, and digital health can offer fresh perspectives and innovative research questions.
Transforming a research idea into an actionable study plan requires a straightforward, well-defined question and a detailed, ethical approach. By focusing on feasibility, importance, novelty, and ethics and continuously building expertise, researchers can develop impactful studies that advance clinical knowledge and improve patient outcomes.
Streamline your clinical research with our Clinical Trial Risk Tool. Use AI to derive accurate cost and risk estimates from clinical documents, enhancing your study’s feasibility and effectiveness. Try the Clinical Trial Risk Tool today!
#ClinicalResearch #ResearchMethodology #StudyDesign #ClinicalTrial
Reference:
Browner, Warren, S. et al. Designing Clinical Research. Available from: Wolters Kluwer, (5th Edition). Wolters Kluwer Health, 2022.
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.
