A “clinical study” is generally defined as any study that involves people. The involvement of people in research is highly regulated by governments and requires a number of additional steps over a laboratory study. These steps frequently add to the length of time it takes for a study to begin or to be completed. Some of the main steps include:
• Defining the study concept, securing financial resources to support the study, and seeking out new collaborations with various experts who haven’t necessarily worked together before.
• Developing a detailed protocol or blueprint of the study’s scope, type and number of participants to recruit, frequency of visits or scans, data to be gathered, and specific step by step procedures for each phase of the study to ensure that each participant undergoes the same protocol.
• Developing one or more “Informed Consent” documents. These are explained to participants, and they are required to sign them indicating that they understand what is entailed and agree to being involved in the study.
• Applying for approval to begin the study from an Institutional Review Board (U.S.) or Research Ethics Board (Canada), including approval of the Consent Form and other plans. This step is required by governments to ensure adherence to guidelines related to the protection of human subjects in research.
• Hiring staff needed to conduct the study, and getting staff trained in the protocol and any particular techniques to be used.
• Buying or bartering equipment, clinic time, extra space, as needed.
• Establishing a monitory committee to provide oversight and feedback on any research or safety issues encountered.
• Recruiting and screening participants and obtaining their informed consent.
• Conducting the study, including performing scanning, clinical evaluations and other data collection. Some protocols require repeated scans or additional scans, meaning additional clinic visits.
• Gathering and evaluating the cumulative data from all participants.
• Communicating and publishing results.
Read more about steps involved in clinical research on the Website of the National Institutes of Health