Still to open Discovering Trends in Chronic Fatigue Syndrome Patients' Clinical Study Experiences, Power Life Sciences Inc., California

Andy

Retired committee member
Study Overview

Brief Summary

The study seeks to delve into the firsthand experiences of patients diagnosed with chronic fatigue syndrome who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

The data collected from this study will help improve future outcomes for all chronic fatigue syndrome patients as well as those in under-represented demographic groups.

https://clinicaltrials.gov/study/NCT05967494
 
It's good that someone is studying the processes of clinical trials. A clear list of known flaws will help people to judge future trials. Published papers could have a "flaws rating" included. Of course, unethical researchers will invent new flaws to exploit.
 
(@duncan https://www.withpower.com/about/michael-gill)

Studies a U.S. FDA-Regulated Drug Product
No

Studies A U.S. FDA-Regulated Device Product
No

from the consent form

As an observational clinical trial participant, you can rest assured that there will be no treatment recommendations or changes to your existing treatment regimen. The primary aim is to gather an extensive array of data and insights concerning chronic fatigue syndrome, its progression, and its profound impact on patients' lives. By participating in this study, you have the remarkable opportunity to contribute significantly to the growing body of knowledge and potentially influence future advancements in chronic fatigue syndrome.

Rest assured, your primary care doctor's prescribed treatment and methodology will remain entirely unaffected by your participation in this observational study. The overarching aim is to acquire a comprehensive understanding of your journey without exerting any influence on your ongoing treatment plan.

It isn't made clear what if any separate study this study is evaluating. Or is it enrolment in any separate study?

The first of three references submitted is —

The effectiveness of cupping therapy on chronic fatigue syndrome: A single-blind randomized controlled trial (2020, Complementary Therapies in Clinical Practice)
 
The consent form is something else —

Affirmation of Informed Consent

With utmost assurance, I confirm that I have devoted ample time to thoroughly read and comprehend the entire contents of the informed consent form, either independently or with the invaluable support of a trusted individual who diligently read it to me. Each of my queries and uncertainties has been thoughtfully addressed to my absolute satisfaction.

I am unequivocally cognizant that my engagement in this study is entirely voluntary, granting me the liberty to withdraw my consent at any juncture, devoid of any obligation to furnish a rationale or encounter any financial encumbrance. Equally significant, I have been duly apprised that a copy of this informed consent form will be furnished for my personal record-keeping.

Following meticulous contemplation and contemplative introspection on all the disseminated information, I wholeheartedly bestow my consent to participate in this study, driven purely by my own volition.​
 
So With Power or Power is a patient recruitment site for clinical trials. Kind of a dating site: you can post your disease and its stage or other nomenclature and "looking for a clinical trial for x disease". Post a photo, even.

With Power seems to be a middle man between the patient-potential recruit and the big pharma sponsor of the clinical trial. I assume that the sponsor pays With Power per patient recruited via their site.
 
The consent form is something else —

Affirmation of Informed Consent

With utmost assurance, I confirm that I have devoted ample time to thoroughly read and comprehend the entire contents of the informed consent form, either independently or with the invaluable support of a trusted individual who diligently read it to me. Each of my queries and uncertainties has been thoughtfully addressed to my absolute satisfaction.

I am unequivocally cognizant that my engagement in this study is entirely voluntary, granting me the liberty to withdraw my consent at any juncture, devoid of any obligation to furnish a rationale or encounter any financial encumbrance. Equally significant, I have been duly apprised that a copy of this informed consent form will be furnished for my personal record-keeping.

Following meticulous contemplation and contemplative introspection on all the disseminated information, I wholeheartedly bestow my consent to participate in this study, driven purely by my own volition.​
Sounds like they have got Charles Dickens on the writing
 
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