If you feel a clinical study may be an appropriate option for a patient, you can follow the steps below to find the best study and to refer the patient:
This website includes important information about current PHN studies, inclusion and exclusion criteria, study procedures, patient time commitment and contact information. You will also find patient brochures for each study that outline the study purpose and procedures and can be printed and given to the patient.
Another way to identify an appropriate study is to utilize the information at ClinicalTrials.gov and place a key word in the search box. Summaries of the studies include study objectives, eligibility criteria, and contact information for the study’s investigators.
After reviewing the information, you may want to contact the principal investigator or research coordinator to further discuss eligibility and protocol requirements. You might be asked to provide specific medical information or test results to determine eligibility.
Inform your patient about the study and, if he or she is interested in participating, provide the patient with the study team’s contact information. Someone from the study team will discuss the details of the study, such as time commitments, potential side effects, and other information needed to make an informed decision. If the patient lives a distance from the study site, travel arrangements will be discussed as well as what is paid for by the study.
Frequent communication with the study team is important for maintaining the high level of care for a patient enrolled in a study. Feel free to contact the research team at any time with questions or concerns that you may have about your patient or the study in which she or he is enrolled.
It is especially important to share information about hospitalizations, visits to the ER or physician’s office. Any adverse event or side effect (whether you think it is related to the drug or intervention or not) should be reported to the study team. In addition, the study team will want to know how to contact you and inform you of events that occur during the course of the study.
Participation in a clinical trial may afford access to the latest investigational therapies in a closely monitored setting, and yet only a small proportion of eligible patients enroll in clinical trials each year.
There has been research into why people do or do not participate in clinical research. The findings are as varied as the participants themselves, however some reasons include1:
Caldwell et al (2002) discuss perceived risks and gains for pediatricians in their article, “Pediatricians’ attitudes toward randomized controlled trials involving children”.2
Perceived risks may influence whether the healthcare provider will refer a patient for study participation and may include:
Perceived gains may include: