The primary responsibility of a clinical trial researcher is to oversee the process of testing drugs and medical procedures on human subjects, ensuring that the procedures are ethical, safe, and properly reported to regulatory authorities. Investigators are typically trained physicians with significant experience practicing in one or more of the trial’s fields. For example, a well-known oncologist might agree to look into a cancer drug trial; he or she would have the subject matter expertise to predict likely outcomes and could also inform participants and staff members about what to expect. This person is in charge of a number of important tasks, starting with getting the trial approved and enrolling participants; then, he or she is usually in charge of ensuring that the actual testing goes as planned, and finally, tabulating and publishing the results. Most investigators do all of this while continuing to see patients and maintain a regular practice. They are usually compensated for their participation, which is one incentive, and many also enjoy the opportunity to network with other professionals and broaden their knowledge.
Role of Oversight
Most countries require pharmaceutical drugs to go through a series of tests before being sold to the general public, and the clinical trial process is one of the most common ways for regulators to learn about a drug’s capabilities and risks. Drug companies are usually the first to propose trials and start putting them together, but they can’t always run them on their own. Most countries’ laws require a large number of outside actors to participate in order to ensure, among other things, the reliability and impartiality of the results. In most cases, the clinical trial investigator is the most important person involved in the process.
This person’s primary role is investigative, as the title implies. He or she ensures that everything is done “the book” and in accordance with all regulations. This can range from ensuring that any physical research facilities are up to code to regulating how patient data is stored, identified, and ultimately shared. Investigators are similar to project managers or bosses in that they supervise and have the authority to delegate work to others, but they are usually responsible for the final result.
Obtaining the Required Approval
The investigator may also be responsible for the administrative work required to get the trials approved local and national regulatory officials. In most cases, the drug manufacturers have done at least some preliminary work on this front, but as the trial progresses and people begin to enroll, it’s up to the investigator to ensure that the appropriate authorities are aware of what’s going on and that all necessary filings are in place.
Another important aspect of the job is obtaining human subjects to serve as trial participants, which is sometimes one of the reasons physicians want to work as investigators in the first place. Many of the most cutting-edge drugs for the most severe diseases are only available in clinical trials. Patients who haven’t responded to over-the-counter medications are ideal candidates for clinical trials, and for terminal patients, the possibility that a tested medication will work can be life-saving. Trials for common conditions and medications, on the other hand, frequently have long waiting lists. Physicians who serve as investigators can sometimes prioritize their own patients, ensuring a full trial and a roster of patients who are known to the administrator — at least to some extent.
Investigators usually take steps to ensure that all aspects of the testing are carried out consistently, from the patient’s position during drug administration to the intervals at which results are recorded. The investigator is also in charge of wrapping up the trial and analyzing the results, as well as preparing a formal report that will be sent to both the manufacturer and the government regulatory agency.
In most cases, the investigator’s job is done once these papers are filed, but there are times when he or she may be called upon to answer questions or defend decisions. This is most common when FDA approval is denied, or when problems arise later, such as side effects or other adverse reactions that were not discovered or disclosed during testing.
Other Responsibilities to be Balanced
To be an investigator, a doctor does not typically need to be affiliated with a teaching hospital or medical school, nor does he or she need prior experience. The exact process for becoming a clinical trial investigator varies location, but in many cases, interested physicians file their information with commercial trial organizers, who will notify them if a pending trial in their area requires their expertise.
Following that, the physician will most likely need to meet with a drug manufacturer or a representative to learn more about the project. One of the most crucial considerations for the physician is how he or she will manage the trial while continuing to work. Trials take a long time to complete, but investigators rarely take time off from their other responsibilities to participate.
When a physician considers participating in a clinical trial, he should think about whether the trial will be appropriate for his patient population. He should also think about whether he has the necessary equipment to conduct the trial. Another requirement is adequate staffing to carry out all of these tasks.