With 11 total outcome measures(2 primary, 9 secondary)per patient and each outcome measure being taken 9 times(baseline and every 2 wks) during 16 weeks(12 wks tment, 4 weeks followup) would yield 99 measurements per patient(11om/ptx9 pt visits). 99om/ptx 199pts=19701 total outcome measures(another way of saying it is 11om's/pt visitx199pts=2189om's/visit x 9visits=19701 total outcome measures.)
The final om's are taken and noted at the week 16 final visit and those 19701 om's(probably one piece of paper per patient in table format listing 11 rows of outcome measures and 1 column for each visit(9 total). I would think a trend in any one direction would stand right out by just reading across an outcome measures row and compare to baseline, much like a report one gets from their doctor after an annual visit where the patient can see clearly the change from previous measurements.
It's been about 176 days(5 mos. and 25 days) since 12/21/18. Take out 12 days for the end of december and new years, back out 23 weekends(46 days) and the 3 holidays after new years=115 workin daysx8 man hours/working day=920 hrs if one person is working on the analysis(the outcome measures appear pretty standard for a psoriasis trial).
Regarding your quote "....I believe we have a huge winner and thanks for the CRO having issues with collecting and posting the data in a timely fashion, I am getting discounted shares." I thought the data was collected at the 34 sites for the cro to analyze. Maybe ipix has not paid some of the sites as agreed and therefore some data has not been handed over to the cro? Who knows, the company is saying nothing.
Below are section copied and pasted from the CTI site, including a full description of the 11 primary outcome measures:
A subject studied under this clinical protocol will commence with a screening period of up to 4 weeks, a treatment period of 12 weeks, and a follow-up period of 4 weeks ending with an End of Study evaluation.
During treatment, subjects will return to the study center every 2 weeks. Efficacy assessments, including physician and patient rated endpoints, will be measured throughout the study. Safety and tolerability will be assessed by ascertainment of AEs and results of clinical laboratory testing, vital signs assessments, and need for concomitant medications.
At a subset of sites, blood samples for determination of plasma concentrations of Prurisol (abacavir glycolate) and abacavir, it's metabolite, will be obtained from subjects who consent to provide these samples. At selected sites, for those subjects consenting to photography, standardized digital photographs will be obtained for illustrative purposes.
Primary out come measures
1.Proportion of participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12 [ Time Frame: 12 Weeks ]
The Psoriasis Area and Severity Index (PASI) quantifies the severity of psoriasis based on lesion severity and the percent of body surface area affected. It is a composite assessment, across body regions, reflected in a single score: 0 (no disease) to 72 (maximal disease).
2.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 16 Weeks ]
Reporting of Adverse Events measurements, and reporting of adverse events.
Secondary Outcome Measures :
1.Proportion of subjects achieving a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline [ Time Frame: 16 Weeks ]
The static Physician Global Assessment reflects an overall severity of the erythema, induration and scaling across all psoriatic lesions on a 5-point scale, where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
2.PASI75 response at time points through Week 16 [ Time Frame: 16 Weeks ]
The Psoriasis Area and Severity Index (PASI) quantifies the severity of psoriasis based on lesion severity and the percent of body surface area affected. It is a composite assessment, across body regions, reflected in a single score: 0 (no disease) to 72 (maximal disease).
3.The actual and change from baseline in patient-reported itch severity score [ Time Frame: 16 weeks ]
The severity of itching due to psoriasis will be assessed on a horizontal numeric rating scale, anchored by the terms "No itching" (0) and "Worst possible itching" (10).
4.Assessment of patient-reported quality of life by the Dermatology Life Quality Index (DLQI) [ Time Frame: 16 Weeks ]
The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology questionnaire that assesses patient health-related quality of life in adult subjects with skin diseases such as psoriasis
5,Assessment of patient-reported quality of life by the Short Form-36 Health Survey (version 2, acute form) [ Time Frame: 12 Weeks ]
The SF-36 is a widely used general health status questionnaire that assesses 8 domains of functional health and well-being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions
6.Assessment of patient-reported quality of life by the Euro-Qol 5 Dimensions Health State Profile [ Time Frame: 12 Weeks ]
The EQ-5D is a generic instrument designed to assess a subject's general health status. The instrument consists of a questionnaire and a visual analog scale (VAS)
7.Assessment of Patient Satisfaction with Study Treatment (PSST) [ Time Frame: 12 Weeks ]
Overall patient satisfaction with study treatment will be assessed on a 7-point rating scale, with response options range from "very dissatisfied" to "very satisfied"
8.Plasma concentrations of Prurisol [ Time Frame: 4 Weeks ]
Measurement of Prurisol (abacavir glycolate) from a subset of subjects in the trial
9.Plasma concentrations of abacavir [ Time Frame: Timeframe: 4 weeks ]
Measurement of abacavir, a metabolite of Prurisol, from a subset of subjects in the trial
