This post originally appeared on Fast Data Science’s blog on LinkedIn.
Formulating a robust research question is the foundation of any successful clinical research study. This fundamental step shapes the entire project’s direction, feasibility, and impact. Let’s explore the essential aspects of crafting an effective research question.
The best research questions for seasoned investigators often stem from their prior studies or field observations. However, new investigators, although lacking extensive experience, can bring fresh perspectives that might lead to innovative approaches. It’s crucial to differentiate between a research interest and a research question. For instance, the question, “Does providing a regular basic income reduce depression among middle-aged adults?” arises from a broader interest in social determinants of health.
To identify a compelling research question:
Reflect on studies that have piqued your interest.
Consider clinical scenarios where patient outcomes could have been improved.
Question current practices and their effectiveness.
A substantial research question should be Feasible, Important, Novel, and Ethical (FINE):
Feasible: Ensure the study can be practically conducted with available resources, including sufficient participants.
Important: The question should address a significant issue that can impact patient care or advance scientific knowledge.
Novel: It should contribute new insights or challenge existing paradigms.
Ethical: The study must respect ethical standards and obtain necessary approvals.
Becoming an expert in your chosen area is fundamental. Conduct thorough literature reviews and stay updated with recent advances by:
Attending scientific meetings.
Engaging with experts and following thought leaders.
Utilizing resources like ClinicalTrials.gov and Prospero for ongoing research and systematic reviews.
Research ideas can emerge from various sources:
Clinical experiences and observations.
Collaborations with other investigators.
Teaching and discussions with students.
Informal conversations at conferences.
Creativity plays a vital role in this process. Embrace new technologies and methodologies to generate innovative research questions.
The journey from identifying a research interest to formulating a feasible research question requires careful consideration, thorough research, and creativity. By focusing on the FINE characteristics and continuously building your expertise, you can develop impactful research questions that pave the way for meaningful and valid studies.
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Source:
Browner, Warren, S. et al. Designing Clinical Research. Available from: Wolters Kluwer, (5th Edition). Wolters Kluwer Health, 2022.
#ClinicalResearch #ResearchMethodology #HealthcareInnovation #ScientificInquiry
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.
