Multiple Sclerosis Outcome Assessments Consortium (MSOAC)


At a Glance
  • Status: Active Consortium
  • Year Launched: 2012
  • Initiating Organization: C-Path
  • Initiator Type: Nonprofit foundation
  • Rare disease
  • Disease focus:
    Multiple Sclerosis
  • Location: North America

Abstract

The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) is a public-private partnership which aims to accelerate the development of new therapies for MS by generating new tools for measuring outcomes in clinical trials. It is collecting, standardizing, and analyzing data about MS with the goal of qualifying new measures of disability for the disease.  MSOAC is the newest of the eight consortia of Critical Path Institute (C-Path), a nonprofit organization that is dedicated to accelerating drug development by delivering on the mission outlined by FDA’s critical path initiative. 

Mission

Multiple Sclerosis Outcome Assessments Consortium (MSOAC) has a mission to develop improved clinical outcome measures for Multiple Sclerosis (MS) trials.  The overarching goal of MSOAC is to develop a sensitive, clinically meaningful, and reliable clinician-reported outcome (ClinRO) measure that can be qualified by the regulatory agencies for use as a primary endpoint in clinical trials aiming to reduce, stop, or reverse MS disability progression. In order to achieve its aim it is:

  • Creating data standard for MS, which will be developed in collaboration with the standards setting organization Clinical Data Interchange Standards Consortium (CDISC).

  • Creating a database of MS trials in which the legacy data is remapped to the CDISC standard so that studies can be pooled for analysis and submission to the FDA and European Medicines Agency (EMA) in partial support of new measure qualification

The consortium focuses on sharing precompetitive patient-level data from the control arms of legacy clinical trials, developing new tools to be submitted to the regulatory agencies, and developing consensus data standards. The specific goals include:

  • Establishing a mechanism for the various participants in the MS drug development  to engage with patients and patient advocates

  • Generating a data standard for MS starting with the National Institute of Neurological Disorders Stroke (NINDS) Common Data Elements that have already been developed for MS

  • Developing a mechanism for data sharing, and analysis of data already collected but largely unanalyzed.

  • Establishing a pathway for qualifying better outcome measures for use in future MS clinical trials

  • Contributing to international harmonization of methods and standards, which could improve the efficiencies of world-wide drug development for MS.

  • Ensuring that those aspects of disability that are of most importance to patients and families are taken into consideration.

2012

The National Multiple Sclerosis Society and Critical Path Institute (C-Path) came together to launch the Multiple Sclerosis Outcome Assessments Consortium (MSOAC)

2013

MSOAC held its first annual workshop with the US FDA and the EMA on 1st April in Maryland.  The meeting was launched by Dr.Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research.

MSOAC published its Initial project plan which was published in Multiple Sclerosis Journal.

The consortium submitted their letter of intent to the FDA and EMA for developing clinical outcome assessment tool for future MS clinical trials.

Structure & Governance

Multiple Sclerosis Outcome Assessments Consortium, MSOAC, is a consortia of Critical Path Institute (C-Path) and is governed by C-Path’s Executive Committee. Similar to other C-Path institutes, the Executive Director of MSOAC is a staff member of C-Path and has subject matter expertise. In addition to the Executive Director, C-Path also employs an Associate Director, Project Manager, Project Coordinator, Data Managers and the resources are provided by the sponsoring organizations.

MSOAC also has a liaison from the FDA and EMA to advice on issues relating to qualification of a clinician-reported outcome measure. Like other C-Path consortia a coordinating committee develops the global mission, values, and objectives for the consortium and provides oversight and high-level guidance for all activities.  Its membership is composed of representatives of each member organization. This committee is responsible for overseeing the priorities and resources of the consortium and sets both short and long term objectives to be carried out across the disease state initiatives.

MSOAC coordinates their research activities through several working groups that provide advice, support and review across multiple activities and project teams.

Financing

As the umbrella organization for the Multiple Sclerosis Outcome Assessments Consortium, MSOAC, the Critical Path Institute’s (C-Path) revenue is generated mostly from membership dues and grants.  C-Path also receives financial support through a contract with the FDA.

Intellectual Property

The output of the collaboration is within the precompetitive space and intellectual property created is owned by the consortium as a whole.  According to the membership agreement, the content and information from the consortium is deemed confidential to MSOAC members and all external disclosures are approved by members.

Data Sharing

As a recently created organization, MSOAC has outlined its plans to work with its various members to share, collect and analyze historical as well as newly generated data. The consortium has also made data sharing a priority by specifying that the development of a data sharing mechanism is a success measure for the consortium.

Points of Contact

Lynn Hudson, PhD, CSO and Executive Director, MSOAC
Critical Path Institute
1730 E. River Rd.
Tucson, AZ 85718

Sponsors & Partners

Critical Path Institute

European Medicines Agency

U.S. Food and Drug Administration

National Institutes of Health/National Institute of Neurological Disorders and Stroke

Abbvie

Acorda

Biogen Idec

EMD Serono

Genzyme/Sanofi

GlaxoSmithKline

Novartis International AG

Genentech/Roche

Teva Pharmaceutical Industries Ltd

Alberta Multiple Sclerosis Research Foundation

Consortium of Multiple Sclerosis Centers

Fast Forward

Italian Multiple Sclerosis Society (AISM)

Multiple Sclerosis Society UK

Multiple Sclerosis Society of Canada

National Multiple Sclerosis Society

Brigham and Women’s Hospital

Cleveland Clinic Foundation

Imperial College London

Johns Hopkins

McGill University

Mount Sinai School of Medicine

New York University

Plymouth University Peninsula Schools of Medicine & Dentistry

Scientific Institute H.S. Raffaele, Milan

Stony Brook Medicine

University College London

University of Alabama

University of British Columbia

University of Buffalo

University of Genoa

University of Illinois

University of Pennsylvania and Hospital for Sick Children

University of Rochester

University of California, Irvine

University of Virginia

University of Washington

VU Medical Centre Amsterdam

Washington University


Last Updated: 04/08/2016

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