A clinical trial researcher’s main job is usually to oversee the process of testing drugs and medical procedures on human subjects, making sure that the processes are ethical, safe, and reported properly to the governing authorities. In most cases investigators are trained physicians with significant experience practicing in one of more of the fields covered by the trial. A renowned oncologist, for instance, might sign on to investigate a cancer drug trial — he or she would have the subject matter expertise to quickly anticipate likely results, and could also prepare participants and staff members about what to expect. This person has a number of important responsibilities, beginning with getting the trial approved and enrolling participants; from there, he or she is usually in charge of making sure that the actual testing goes as planned, then must tabulate the results and get them published. Most investigators do all of this in addition to maintaining a regular practice and continuing to see patients. They are typically compensated for their involvement, which is one incentive, and many also like the chance to meet other professionals and expand their skills.
Most countries around the world require pharmaceutical drugs to undergo a series of tests before they can be sold to the general public, and the clinical trial process is one of the most common ways for regulators to get a sense of what a drug is capable of and what its risks are. Drug manufacturers are usually the first to propose trials and start getting them arranged, but in most cases they can’t run them entirely on their own. The laws of most countries require robust participation from a number of outside actors, to ensure reliability and impartiality of results among other things. The clinical trial investigator is usually the most important person in the process.
As the title implies, this person’s primary role in investigative. He or she makes sure that everything is run strictly “by the books” and follows all required protocol. This typically includes everything from making sure that any physical research facilities are up to code to regulating how patient information is stored, identified, and ultimately shared. Investigators are essentially like project managers or bosses who oversee and have the power to delegate work to others, but they themselves usually bear ultimate responsibility for the outcome.
Getting Necessary Approval
Doing the administrative work necessary to get the trials approved by local and national regulatory officials may also fall on the investigator. In most cases the drug manufacturers have done at least the preliminary work on this front, but as the trial develops and people start enrolling, it’s usually up to the investigator to make sure that the appropriate authorities know what’s going on and have all the right filings.
Actually getting human subjects to serve as trial participants is another important aspect of the job, and is sometimes one of the reasons physicians want to work as investigators in the first place. Many of the most cutting-edge drugs for really aggressive illnesses are only available in trials. Patients who haven’t responded to medications that are available on the mass market are some of the best people to participate in trials, and in terminal patients the possibility that a tested medication might work can be life-saving. At least for popular conditions and medications, though, trials often have long waiting lists. Physicians who serve as investigators can sometimes prioritize their own patients, which ensures both a full trial and a roster of patients that are known — to at least some degree — by the administrator.
Investigators usually take steps to make sure that all portions of the testing are conducted in exactly the same way, including everything from patient position during drug administration to the intervals at which results are recorded. The investigator is also usually responsible for wrapping up the trial and analyzing the results, then turning those results into a formal report that will be sent both to the manufacturer and to the governmental regulatory authority.
In most cases the job ends once these papers have been filed, but there are instances when the investigator may need to be on hand to answer questions or defend decisions. This is most common when approval is denied, or when problems arise later on with things like side effects or other adverse reactions that weren’t discovered or disclosed during testing.
Balancing Other Responsibilities
A doctor does not typically need to have an association with a teaching hospital or medical school to be an investigator, nor does he or she need to have prior experience to qualify. The exact process for becoming a clinical trial investigator can vary from place to place, but in many instances interested physicians put their information on file with commercial trial organizers, who will then alert them if a pending trial in their area is looking for someone with their expertise.
From there, the physician will probably need to interview with the drug manufacturer or its representative, and will learn more about the work. One of the most important factors the physician needs to consider is how he or she will manage the trial while also continuing to work. Trials typically take a tremendous amount of time, but investigators don’t often halt their other obligations while participating.
When a physician considers the possibility of participating in a clinical trial, he might want to consider if the trial will fit into his patient population. He should also consider if he or she has the equipment required to conduct the trial. Adequate staff to perform all of these duties is another requirement.