1. Introduction: An Overview of Clinical Research Processes

According to the United States National Institutes of Health, clinical research is research with human subjects that is:

  1. Patient-oriented research. This is research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator directly interacts with human subjects. This research includes: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new technologies. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual
  2. Epidemiological and behavioral studies
  3. Outcomes research and health services research.

1.1 Identify the Research Question

On the meaning of life, "Forty-two!" yelled Loonquawl. "Is that all you've got to show for seven and a half million years' work?"

"I checked it very thoroughly," said the computer, "and that quite definitely is the answer. I think the problem, to be quite honest with you, is that you've never actually known what the question is."

-Douglas Adams "The Hitchhiker's Guide to the Galaxy"

While it is difficult to determine if a research question is "good" or "bad", the most important point is to clearly define a specific research question. The question will often be relevant to clinical practice and patient care. Like priority-setting or question-forming processes in other areas, there are certain criteria that are useful to help researchers form a clinical research question. Here are some examples of issues to consider when forming a clinical research question:

  • Importance and relevance
  • Originality
  • Feasibility (both technical and financial)
  • Ethical considerations

Go to the Feasibility section to learn more about feasibility assessment

1.2 Develop a Research plan

A detailed research plan should include the research goal(s) and objectives, research strategy (population, data sources, study design, patient enrollment, intervention(s), and analytical plan), and how knowledge will be translated and disseminated.

A single study method cannot be applied to all clinical research questions. Choosing the right research design and method is one of the most important steps in planning and developing a clinical study. Check the overview of clinical research designs for information on different clinical research methods and the most appropriate method for your research question.

Go to the Proposal Development section to learn more about research proposal development

1.3 Seek Research Funds

Public (both governmental and non-governmental) funding organizations (e.g.,: CIHR, NSERC, SSHRC, NIH, Research Manitoba, and MMSF) and industry (i.e., pharmaceutical or medical device company) are the two main clinical research funding sources.

Go to the Funding section to find out funding opportunities

1.4 Obtain Approvals to Conduct the Research

Researchers must obtain approvals prior to conducting research involving humans. Reviews and approvals of research can come in many forms. You may be first required to have your proposed research reviewed through a peer-review or departmental review and approval process. Some studies, particularly data intensive research projects, may require a “feasibility review” to ensure the data exists and objectives are sound and practical. At minimum, most studies require ethical review and approval from a recognized Research Ethics Board (REB). You may also be required to submit your proposed research for institutional impact review at the institution where the research is being conducted. Research using patient data will often require privacy review and approval and studies being conducted under a contract (i.e. industry sponsored clinical trials) will require legal review of contracts and data user/sharing agreements. Finally, for research involving vulnerable populations, such as First Nations or Indigenous populations, further approvals may be required.

Go to the Approvals section to learn more about obtaining research approvals

1.5 Conduct the Research

Researchers may encounter many technical and administrative issues in conducting a research project. On this website, we list resources for supporting the conduct of your research involving humans.

Go to the Conduct Research section to learn more about the resources and tools

1.6 Report Research Findings

Writing and publishing a research article may be challenging, but there are many valuable and useful resources, including statistical consulting services, writing guidelines, scientific writing assistance, etc.

Go to the Publish section to learn more about the reporting of research findings