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Clinical research investigators can use many different tools available to them through their practice and the study sponsor to ensure that they are active enrolling clinical research sites, such as study-specific Web sites, dedicated information lines, and educational sessions. If these tools are approved by the study sponsor and used properly through outreach in conjunction with proper processes and internal controls, a clinical research study will facilitate growth within a medical practice while ensuring that the investigators become or continue to be key opinion leaders within their specialty.
KEY WORDS: Clinical research investigator; clinical research coordinator; patient recruitment; marketing; clinical research study.
The National Institutes of Health defines a clinical research study as a scientific study of how a new medicine or treatment works in people. The very nature of clinical research seems to require and facilitate an investigator to grow his or her medical practice, but a study investigator in any research study can be at either a passive enrolling clinical research study site or an active enrolling clinical research study site.
A passive enrolling research study site is one that relies solely on its current patient population to find qualified subjects for the research study. These sites do not attempt to engage in the recruitment of qualified study patients. A patient at a passive enrolling study site may only be aware that his or her doctor is an investigator in a study that the patient may qualify for and benefit from if the investigator remembers to mention the study to the patient during the patient's visit
Passive study sites often do not have processes in place to ensure the practice is screening all possible candidates for the study. The lack of processes and outreach could be the reason that some sites have very low enrollment over the course of a couple of years. For example, in a medical device study that requires 400 total patients, a passive research site may enroll only three or four patients total over a two- to three-year period of open enrollment. During that same time period, an active enrolling study site may enroll 45 to 60 patients.
Both types of sites may have investigators that are passionate about research, both sites may have a dedicated research staff,...