Self Reporting Accuracy

PRO-ACT Database

The Pooled Resources Open-Access ALS Clinical Trials Database (PRO-ACT) is a database used by many researchers.  It contains detailed records of over 8,500 ALS patient records in over twenty completed clinical stage II/III trials.


There are 824 placebo arm subjects which equates to 824 placebo patient years. These subjects emerge after being filtered out from the 7,000 total  to using the following criteria:

- Scored in accordance with the modern ALSFRS-R system


- Clinical trial duration of 1 year, +/- 23 days.  Subjects do not necessarily attend their trial clinic on day 365.


- Greater than a 2 point decline over 1 year. (Less than 2 points in one year is considered a possible misdiagnosis)

Note: There are relatively few ALS clinical trials that are less than one year.

Note: The monthly decline rate in treated patients in the PRO-ACT database demonstrates a 3.01% increase in monthly decline.  

More informati

on on the PRO-ACT database can be found HERE.

PRO-ACT vs. RCH4 Research Charity

Using the PRO-ACT database, it is certain that the average monthly ALSFRS-R score decline in all ALS patients is -1.028 points per month BEFORE any treatment is administered. 

The database from the RCH4 Research Charity shows the average monthly ALSFRS-R score decline in ALS patients BEFORE starting on RCH4 is -1.148 points.  This database uses self-reporting from patients.

AFTER starting on RCH4, patients see an average monthly decline rate of only -.0242 points.  This average includes both responders and non responders to RCH4. The efficacy of RCH4 when including non responders is 62% (p=.0001) slowing of the disease ALS compared to patients numbers before starting on RCH4. However, if non responders are not included in efficacy numbers, then the efficacy number is 70% (p=.0001).  Keep in mind that non responders progression continues and realistically affects averages.

As treatment with RCH4 continues in current patients,  these numbers may change. 

Data is accurate as of September 2016.   

Self-Reporting Accuracy

Between the PRO-ACT and RCH4 Research Charity averages concerning monthly patient decline, there is less than a 3% difference. This confirms the self-reporting spreadsheet, provided by the charity, that each RCH4 patients utilizes once per month is not only accurate, but also accepted by researchers. 

Please read for a further explanation: 

The Journal Amyotrophic Lateral Sclerosis Volume 13, 2012 - Issue 2