Since Mr. Spencer seems to be on the prowl and attempting to make comments to my blog again, I thought I’d bring this closer to the top…
Clinical trials and research studies are extremely valuable to all of us. They bring knowledge and better treatments. To perform clinical trials and studies, researchers often need patients to volunteer for the research.
For many reasons, clinical trials are closely regulated by governmental agencies. Some of those reasons are:
- ensuring the accuracy of the data, and
- protecting the patients who enroll in them.
If the protocols for a trial or study have been reviewed and approved by the review boards that govern them, they will have a clinical trial identification number. The announcement for the trial or study will give you enough information to know if you might be interested. Some studies just gather information. Even so, you want to be careful to whom you give personal and medical information.
If you’re considering participating in a clinical trial or study, here are some points of information that you will want to check out:
- Who are the researchers?
- What are the qualifications of the researchers to be conducting the trial or study?
- What is going to be done with the information gathered and/or the data from the trial results?
- Who is funding the trial or study?
- What is the clinical trial identification number?
This is information everyone who considers a trial or study should have and understand. If you’re likely to be in that position, please either bookmark this post or print it.
I started writing this when I had a Migraine and left it for several days. Now, I’m glad I did. Someone who reads my blog because someone who reads my blog sent me an interesting email the other day. It seems that Barry (Caffeine) Spencer is recruiting for a “trial study.” This is what he has posted on his site:
Participate in a migraine trial study!
Migraine patients are invited to participate as outpatient subjects in a trial study investigating the effect of caffeine abstinence on migraine headaches.
The study period lasts 24 days: a ten day base period, four days of self-imposed weaning from caffeine, and ten days of self-imposed caffeine abstinence. Subjects will record the date and severity of any headaches they get during the study period.
Our reader wrote to Mr. Spencer and asked some of the very questions I’ve listed above. To his credit, Mr. Spencer did reply, but his replies are not ones that I would accept as these needed to join his “trial study.” Here is his reply:
- The principal and sole investigator is me, Barry Spencer. I have no university degree or professional certification, and am not associated with any institution.
- It’s a type of cohort study. There is no control group; subjects act as their own controls. There’s a ten day base period during which subjects don’t alter their usual caffeine intake habits, followed by a four day weaning period during which subjects gradually decrease their caffeine intake to zero, followed by a ten day caffeine abstinence period.
- There is no blind or placebo.
- This first trial study investigates the effect of attempted caffeine abstinence on migraine. A follow-up trial study will investigate the effect of verified caffeine abstinence on migraine.
- The “center” is me, located in the US (San Francisco, California). The subjects communicate with me via email and need not meet me in person.
- This trial study was not registered in a public registry prior to onset of patient enrollment, so there is no clinical trial identifier number. Because the intervention is avoidance of a drug, it isn’t a controlled, clinical investigation of a product subject to FDA regulation, so public registration and reporting of results are not required by FDAAA or US Public Law 110-85.
- The trial study is entirely funded by me, Barry Spencer.
- Where and how the results will be published has not been determined. I will show the results to several prominent headache researchers and ask for their opinions. Because this trial study was not registered in a public registry prior to onset of patient enrollment, biomedical journal editors associated with ICJME can be expected to refuse to consider the results for publication. Nevertheless the results of this study shall be published. If no biomedical journal will publish the results, I will self-publish the results on an Internet website. The efforts of participating subjects won’t be wasted.
No degree, sponsored by no institution, possibly self-published results?
When I see something like this, I have to wonder what the problem with the proposed “study” is. This one is simple enough and potentially inexpensive enough that it shouldn’t be difficult to get professional researchers involved. This is the type of study that could be an excellent fit for a university.
If you’re looking at information about a clinical trial and want to verify its legitimacy, look for it to be listed at ClinicalTrials.gov.