A clinical research program is more than a research clinic; at its core is the collecting and processing of patient data. It is imperative to clinical studies that clinic operations, data coordination and study management be integrated to ensure the collection of complete and accurate data that answer the scientific questions. Subsequent to the conduct of three pilot studies involving 83 patients, a chiropractic research clinic that began full time operation in 1999 has used that experience to develop and define a model for a clinical research program best suited to manage future pilot and full-scale chiropractic clinical studies. There are three primary components of the clinical research program: a study team carries out the research project; a clinic team manages and treats patients in our newly operational clinic; a data coordinating center processes clinical data from our site and, if applicable, other clinical sites. Each of the three components has several required positions that should be filled for each study being conducted in the research clinic. Essential activities of each position are defined to take place within each of four phases relative to a clinical study: pre-study, study initiation, during the study, and post-study. A chiropractic pilot study planned for mid-2000 will be used to implement and test the procedures, protocols, and positions developed for this evolving clinical research program. Details of the clinical research program will be presented along with rationalization for the program’s development, challenges of implementation, and description of the initial employment of the program.
Learning Objectives: 1. Appreciate the challenges of developing a clinical research program appropriate for chiropractic clinical research. 2. Recognize the importance of standardization and protocol to the collection of complete, timely, accurate clinical data. 3. Understand the interrelationship of the components and of the positions within each component of a clinical research program
Keywords: Chiropractic, Infrastructure
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.