Clinical Trial Conundrums
I'm noticing a couple of things that are concerning as I've been working to conduct applied clinical trials of the photobiomodulation devices for people with Parkinson's and dementia. We have been met with a surprising lack of responsiveness that I interpret as being subtly passive aggressive. The specific behaviors I associate here relate to a pattern within doctor's staff and physicians themselves avoiding contact with me when I phone to solicit referrals for the trial. After finally getting through to a person after leaving multiple unanswered voicemails, I then got transferred through a maze of people and told to send information and then call the doctor. I send the information and never get to speak with anyone again and am constantly leaving messages on the office voicemail that go unanswered. I finally reach an office person who then connects me to someone else and on it goes while never getting to speak to the doctors. This pattern has repeated on at least 10 different occasions and while I know everyone is busy...this is not really how I expected to be treated when calling to offer free treatment to their patients.
The most recent experience was with a movement disorders specialist whom I reached out to as they were the only such provider in the area where we were attempting to solicit subjects. Several of their patients had already gone through the trial and the responses were encouraging. The subject in the active treatment group improved significantly and the other guy was in the placebo group and didn't notice much of anything and neither did I on the motor and gait testing. The subjects told the doctor they were participating in a new kind of study and the doctor said that she wanted to hear from me and provide more information about the trial. It was on this basis I reached out and when I finally got them on the phone they acted as if they had no idea who I was or why I was calling! I framed the matter as 'this is a very busy person' until I tried to get in touch after being asked to send information on the trial for them to review. I call and get no response, I email twice asking for feedback or a phone appointment to answer questions and solicit subject referrals and get nothing. This is no longer being busy, this is overt avoidance and now I have to ask myself why would they behave this way? What's the dynamic involved here that would have a physician actively avoid allowing their patients to learn about a noninvasive, non-drug treatment option for a disorder for which they have no thoroughly effective treatment? I'm having to conclude that the idea of suggesting a potential treatment that is outside their realm of expertise is inherently threatening even in those cases where the physician also has a background in clinical research as was the case with the movement disorders specialist. The unconscious resistance to change that exists in all of us also extends into this realm wherein doctors will resist allowing their patients to participate in clinical trials that involve ideas and techniques with which they are not expert or in this case have no familiarity. The fact that the risk profile was negligible was not relevant to the reluctance to support their patients participation.
I understand resistance to change is a normal feature of scientific and other social progressive movements and not to be pathologized. Its sad and frustrating to see it operating in this area of clinical research where we are seeking to show the efficacy of a treatment that can help reduce the suffering of millions of people with little to no risk of side effects. Not sure what there is to be done except to look for those doctors who are not easily threatened and who can support their patients’ participation. My frustration and incredulity are best handled by staying focused on the work and remaining optimistic that we will find doctors and support group leaders that will be more positively disposed toward promoting alternative treatment approaches.
Looking for others' thoughts on how best to attract the cooperation and support from clinicians to refer subjects to our trials.
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