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A clinical trials professional with personal experience as a trial subject discusses the purpose and importance of following protocol.
Reading an informed consent form as a potential clinical trial subject was a surreal experience for me. The research nurse at my dermatologist's office did not know my background—that I had spent the better part of the last 12 years designing clinical trials, writing protocols, and writing informed consent forms (ICF) like the one I held in my hands. To her, I was a potential "healthy, age-matched, female volunteer." When I signed the form, she was gleeful. I was the second to the last person she needed to fully enroll the study at her office. In that instant, I went from patient to clinical trial subject.
According to the ICF, this study involved a single dosing visit where I would receive four injections of a medication into the lips (two injections to the upper lip and two injections to the lower lip). The remainder of the study consisted of follow-up visits.
A few weeks later, I had my treatment visit. The nurse took before photos and swabbed my lips for the injections. My dermatologist breezed in, grasped the syringes, and injected me six times: four spots on my upper lip and two spots on my lower lip. Holding an ice pack to my mouth, I mentioned to her that I thought I was getting four injections. She laughed.
The conversation we had afterwards enlightened me on the ability of a study design to go wrong. Here's what I learned:
Investigator consensus creates a better protocol and better compliance. When the sponsor representatives designed this protocol (and made my dermatologist the lead investigator), they didn't bother to talk to her about the best way to administer the medication.
When I write clinical protocols for clients, one of the questions I ask is whether the investigators will be given the opportunity to weigh in on design. I encourage clients to bring a draft protocol to the investigator meeting and get input. Although this may add a few weeks to the start-up process, it may also lead to fewer amendments and greater compliance.
If a key opinion leader doesn't think a protocol has been written correctly, she will implement it her way. In addition, she may be able to incline other investigators to do the same.
My dermatologist is extremely well published and is a trained speaker for the company sponsoring the clinical trial in which I was participating. As she disagreed with the design and felt it was her study, she conducted the trial as she felt it should have been written. According to the study nurse, the other participating sites were following her lead.
A protocol needs to reflect, not direct, clinical practice. The problem with the protocol was that it didn't respect the way the drug would be used in the field.
Clustering the drug in two large injections in the upper lip did not make sense with the facial musculature and did not reflect how this medication would be used in the clinic. My dermatologist felt the sponsor company wasn't using good judgment on a clinically meaningful administration, so she did it her way.
My experience on the other side of the ICF is something I share with every client when discussing trial design and protocol writing. Though I disagree with how my dermatologist implemented this trial and am sympathetic to the sponsor because of the blatant farce made of the ICF, my encounter was educational. A study is only as good as its protocol and the willingness of investigators to implement it.