Massachusetts General Hospital

A Powerful New Clinical Research Resource: PRO-ACT Database

04/May/2012

Large sample sets are critical for identifying statistically significant and biologically relevant observations, particularly for diseases resulting from the intricate interplay of genetic and environmental factors. Pooled clinical trials datasets have proven invaluable for researchers seeking to unravel such complex diseases as multiple sclerosis and Alzheimer’s Disease.

The Northeast ALS Consortium (NEALS) is partnering with Prize4Life to create a Pooled Resource, Open access ALS clinical trials (PRO-ACT) platform that allows the merging of data from existing public and private sources of completed Phase II and Phase III trials.

An estimated 6500 subject clinical records from four major biopharma companies plus over 1000 clinical records from completed NEALS studies are currently being incorporated into the initial dataset, creating the largest ever existing ALS clinical record database.

The dataset will contain at minimum an estimated 6M datapoints, encompassing a wide range of data types collected from 18 trials over a period of 6-22 months (average 13 months.) Initial analysis of the data suggest that the sample distribution of fast, average, and slowly progressing patients (based on change in ALSFRS slope/month) is roughly similar to that previously described.

The dataset will be made freely accessible to the research community for analysis and download (anticipated release December 2012.)

The uniquely powerful PRO-ACT Platform is the result of a collaborative effort by industry, academic, and foundation partners to pool existing subject records.  The database will be constantly updated to include additional datasets as these become available.  

ALS researchers are encouraged to join the effort by contributing trial data and mining the database for new insights into ALS.

Data mining of the PRO-ACT is expected to lead to the identification of disease biomarkers, provide insight into the natural history of disease, as well as insights into the design and interpretation of clinical trials, each of which would bring us closer to finding a cure and treatment for ALS.

Thanks to the ALS Therapy Alliance for its continuing support, the data donors, and all the patients who participated in these trials.