Clinical trial NCT05503524: Finding Patterns In Clinical Study Experiences of Multiple Sclerosis Patients
Official title: Extensive Clinical Trial Experiences of Multiple Sclerosis Patients To Determine Trial Attributes Affecting Completion Rates For Specific Demographic Groups
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Sclerosis
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multiple Sclerosis patients who are actively considering involvement in an interventional clinical trial, but have not yet completed enrollment and registration.

Brief summary: Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical trial experience of Multiple Sclerosis patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Multiple Sclerosis patients.


Eligibility criteria: Inclusion Criteria:

* Participant has a diagnosis of Multiple Sclerosis
* Patient has self-identified as planning to enroll in an interventional clinical trial for Multiple Sclerosis
* Patient is at least 18 years of age

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
* No diagnosis of Multiple Sclerosis confirmed

Primary outcomes:
measure: Rate of patients who decide to enroll in a Multiple Sclerosis Clinical Trial
timeFrame: 3 months
measure: Number of patients who remain in Multiple Sclerosis clinical trial until completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
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citation: Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.
citation: Belbasis L, Bellou V, Evangelou E, Ioannidis JP, Tzoulaki I. Environmental risk factors and multiple sclerosis: an umbrella review of systematic reviews and meta-analyses. Lancet Neurol. 2015 Mar;14(3):263-73. doi: 10.1016/S1474-4422(14)70267-4. Epub 2015 Feb 4.