My experience in clinical research began many years ago in human trials, first as a nurse and later as an administrator. Though I now work exclusively on the veterinary side, lessons learned during those human trials have shaped my approach to managing animal studies.
I still believe that every investigator and site technician begins each study with good intentions. However, I have learned that, despite intensive protocol and GCP training, certain sites will trade their good intentions for expediency. This fact has spawned skepticism toward study data that continues to serve me well. I’d like to share a few of the more “creative” examples of good intentions gone wrong which, to maintain confidentiality, have been disguised.
Case #1 – Reality Check
When the medical record for one study subject could not be located during a site visit, the monitor recorded that fact in her report as an action item for the site to complete before her next visit. Upon her return, that medical record still had not been found. After watching his staff search fruitlessly for the missing record, the investigator sheepishly revealed that he had fabricated the subject to meet his enrollment target.
Case #2 – Lost and Found
During a site visit, the monitor documented the location and condition of test article and reconciled the site’s inventory against their visit reports. Two weeks after the visit, the investigator called to request additional test article. Based on visit reports, the monitor knew that additional test article was not warranted. So, she scheduled another site visit. Upon arriving at the clinic, the monitor asked to use the restroom. Noticing that there was no tissue, she began searching cabinets and shelves. In the process of securing a new roll, she also located the missing test article among boxes of supplies.
Case #3 – Strip Tease
While closing out a site during a canine cardiology trial, the monitor noted that the EKG and all required documentation for the last study subject had been completed, so he forwarded it to the consulting cardiologist for review. Two days later, the cardiologist called to tell the monitor that the last subject’s EKG was for a cat, not a dog. When the monitor presented this information to the investigator, she adamantly disagreed. However, after further discussion with the site staff, one of the technicians admitted that she had forgotten to do an EKG on the last study subject and had submitted an EKG that she had taken on a cat earlier that day. The investigator then conceded that she had signed off on the case without a thorough review.
Case #4 – All Fired Up
The investigator and site staff were so enthusiastic during protocol training that everyone assumed that they would perform well during the study. During the first site visit, though, the monitor discovered quite a few errors. She noted each error with a Post-it ™ flag and left the investigator detailed instructions regarding corrections. At her next site visit, the monitor found that most of the earlier errors had been corrected. However, many of the new forms had similar errors. The monitor reviewed the protocol with the site staff and again left Post-it™ flags and detailed instructions. This scenario repeated several more times with growing frustration for both the monitor and the investigator. Three days after a particularly contentious visit, the site called the monitor to tell her that there had been a fire in the room where the study binders had been stored.
Case #5 – Big Daddy
One clinic had enrolled more cats in less time than any other site, and the staff was very proud of their achievement. The bubble burst, however, when a review of the demographic forms revealed that the investigator was the “client owner” of most of the cats, which the staff had found abandoned in a local park.
Case #6 – All in the Family
The investigator’s son, a veterinary student at a local university, worked part-time at the clinic. He often helped his father with “paperwork,” including completing and signing data forms for a clinical trial. The monitor discovered this when she asked the son if his father was available to make corrections and the son volunteered that he should make them because he had completed and signed the forms on behalf of his father.
Could these situations have been prevented? Perhaps. But investigators, being human, might detour from their studies’ protocols in other, unanticipated ways.
A more realistic goal would be to catch these deviations early, before they disqualify too many subjects or otherwise jeopardize the success of a trial. To do that, review data quickly, as close to real time as possible. Be skeptical. If it looks too perfect, something could be amiss. And, if someone says, “Trust me!” increase your vigilance until you know that trust is warranted.