Clinical trials are conducted to allow safe and effective data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place. Depending on the type of product and the stage of its development, clinical trials enroll healthy volunteers and/or patients into small studies initially, followed by larger scale studies in patients that often compare the new product with a currently prescribed treatment.
As positive safety data is gathered, the number of patients can be increased. Clinical trials can vary in size from a single center in a single country to multi-centers in multiple countries.
Physician Requirements include:
ICH and GCP Training
Human Participant Protections Education
Willingness to sign a contract
Willingness to comply and participate in the clinical trial until close-out
Previous research experience strongly preferred
Responsibility for the safety of the subjects in a clinical trial is shared between the pharmaceutical company/sponsor, the local site investigators (if different from the sponsor), the various IRBs that supervise the study and (in some cases, if the study involves a marketable drug or device) the regulatory agency for the country where the drug or device will be sold. A physician's first duty is to his/her patients and if a physician investigator believes that the study treatment may be harming subjects in the study, the investigator can stop participating at any time. On the other hand, investigators often have a financial interest in recruiting subjects and can act unethically in order to obtain and maintain their participation. The investigators are responsible for conducting the study according to the study protocol and supervising the study staff throughout the duration of the study. The investigator or his/her study staff are responsible for ensuring that potential subjects in the study understand the risks and potential benefits of participating in the study; in other words, that they (or their legally authorized representatives) give truly informed consent.
The investigators are responsible for reviewing all adverse event reports sent by the sponsor. These adverse event reports contain the opinion of both the investigator at the site where the adverse event occurred and the sponsor regarding the relationship of the adverse event to the study treatment. When an investigator is the sponsor, there may not be formal adverse event reports, but study staff at all locations are responsible for informing the coordinating investigator of anything unexpected. The local investigator is responsible for being truthful to the local IRB in all communications relating to the study.