CBB Biostatistics seminar - How to make a research plan - 14.12.2023

Sep 11, 2026

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CBB Biostatistics seminar guidance on building a study plan and avoiding “research waste” through rigorous protocol development. The material links poorly designed or irrelevant research, and weak or biased reporting, to costly clinical decision-making failures. It explains how a plan supports relevance checks, identifies knowledge gaps, reduces cognitive bias, and enables evaluation of what was actually done. It then details what a study plan includes and how to define clear objectives using frameworks such as PICO and SMART.

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How to make a research plan

The absolute essentials

Research waste

What does research waste have to do with protocols?

How having a plan can help

What is a statistical analysis plan?

What’s in a study plan?

Introduction

Objectives

How to make a research plan The absolute essentials CBB Biostatistics seminar 14.12.2023 Raphaela Mayerhofer Vocabulary • Study protocol • Protocol • Study plan • Analysis plan • Statistical analysis plan • … “It is my great pleasure to be here and make you feel quite sad about how bad things are.” Douglas G. Altman, REWARD-EQUATOR conference, Edinburgh 28-30 Sep 2015. Research waste • Research that could be answered with existing evidence • Research questions that are not relevant to patients or clinicians • Poorly designed studies • Poor or biased reporting ➢ Poor evidence is expensive and leads to poor clinical decisions (1) 1. Heneghan C, Mahtani KR, Goldacre B, Godlee F, Macdonald H, Jarvies D. Evidence based medicine manifesto for better healthcare. BMJ. 2017 Jun 20;j2973. What does research waste have to do with protocols? Moher D, Glasziou P, Chalmers I, Nasser M, Bossuyt PMM, Korevaar DA, et al. Increasing value and reducing waste in biomedical research: who’s listening? The Lancet. 2016 Apr;387(10027):1573–86. → Inadequate planning (1) Karolinska Institutet-a medical university 14/12/2023 5 1. Yordanov Y, Dechartres A, Atal I, Tran VT, Boutron I, Crequit P, et al. Avoidable waste of research related to outcome planning and reporting in clinical trials. BMC Med. 2018 Dec;16(1):87. How having a plan can help • Forces you to check what already exists • Check if your aim is relevant • Identify knowledge gaps, missing equipment,… • Get independent methodological support • If no protocol, difficulty in evaluating what was done • Protect against cognitive biases: making a plan before the data exists and while the outcome is unknown is a form of blinding What is a statistical analysis plan? • A map → Part of a grant application → Clinical trial protocol → Master’s or PhD thesis project → As part of a larger project • Set up before the study begins What’s in a study plan? • Introduction • Justification for study • Objectives • Research questions and hypotheses • Procedures and methods • Study design • Study population • Variables/interventions • Data management • Statistical analysis • Management of adverse or unexpected events Introduction • Justification for study → What’s the health problem? → Who’s affected? → How does your study address the problem? Introduction • Objectives → Clear and concise statements of what the study will demonstrate, test, evaluate, confirm, or compare → PICO • Patient or population of interest, or problem • Intervention or treatment that is performed on P • Comparison or control treatment • Outcome that is to be observed → SMART • Specific • Measurable • Achievable • Relevant • Time-based (realistic time frame)

FAQs

What is “research waste” and why does it matter for protocols?

Research waste includes questions already answerable with existing evidence, irrelevance to patients or clinicians, poorly designed studies, and poor or biased reporting. Inadequate planning reduces the value of evidence and can lead to expensive, low-quality clinical decisions.

How does having a study plan help researchers?

A plan forces checks on what already exists, verifies whether aims are relevant, identifies knowledge gaps and missing resources, and enables independent methodological support. It also helps protect against cognitive biases by planning before data are available.

What does a study plan typically include?

A study plan covers introduction and justification, objectives, research questions and hypotheses, procedures and methods, study design and population, variables/interventions, data management, statistical analysis, and plans for adverse or unexpected events. Objectives should be formulated clearly using PICO and SMART.

Sep 11, 2026

Uploaded by Đào