The key stages of developing a research study are outlined in a short presentation here.
Research problem & Hypothesis
First identify and define the clinical problem, then review the current literature to determine what is known and identify the gaps in the current knowledge, which will direct the research question and study plan. The research question or problem statement presents the idea which is to be examined in the study and is the foundation of the research study.
The hypothesis attempts to answer the research question.
Aims & Objectives
The aims of the study are the changes you hope to achieve as a result of your work, the objectives are the activities undertaken to bring these changes about.
Study design
When designing your study you will need to determine:
• Endpoints
• Prospective / retrospective
• Observational / interventional
• RCT / cohort / case-controlled
• Inclusion / exclusion criteria
• Patient pathway
• Participant involvement
• Statistical help
• Power calculation
Protocol
This needs to be written for the target audience:
• Funders
• Ethics committee
• Researchers delivering the research study
Patient Involvement
You will need to develop Patient Information Sheets and Consent Forms so it is important to get patient and public involvement (PPI) in the research design at this early stage.
Independent Cancer Patients Voice (ICPV), a patient advocate group independent of established UK cancer charities, aims to improve existing treatments for every cancer patient and develop new treatments by bringing the patients’ voice into clinical research. They do this through educating patients about research and also through representing the patient’s voice in the design and running of clinical trials.
INVOLVE is part of, and funded by the National Institute for Health Research, to support active public involvement in NHS, public health and social care research. As a national advisory group their role is to bring together expertise, insight and experience in the field of public involvement in research, with the aim of advancing it as an essential part of the process by which research is identified, prioritised, designed, conducted and disseminated.
Clinical Trials Routemap
The NIHR provides an excellent routemap for developing clinical trials. Although this is targeting Clinical Trials of Investigational Medicinal Products (CTIMPs), it provides an excellent overview of the phases required in trial development.
At this stage, consider getting help from the NIHR Research Design Service.
