The ePROVIDE™ service offered by Mapi Research Trust is the scientific community’s foremost destination for Clinical Outcome Assessment (COA) including Patient-Reported Outcomes (PRO) data.
ePROVIDE™ gives you direct access to Mapi Research Trust’s exclusive COA resources. This includes PROQOLID™, the quality of life instrument database, and PROLABELS™, a marketing authorization and labeling claims database.
The success of Patient-Centered Outcomes (PCO) Research depends a great deal on the choice of appropriate COAs.
Questionnaires should be selected by the domains they measure as well as the populations and pathologies for which they were designed and validated. Such practical issues as the availability of different translations, copyrights, and access to instruments are also important considerations.
To aid you in finding the questionnaire that is right for your study, Mapi Research Trust created the PROQOLID™ database in 2002. It has grown exponentially over the years and today more than 2,200 COAs are comprehensively described, providing its users with two levels of information access:
- Full name of questionnaire & its acronym
- Copyright ownership
- Therapeutic area
- Therapeutic indication
- Type of COA
- Original language
- Bibliographic reference of the original COA
- Mapi Research Trust Catalogue of licensed COAs
- Review copies of original instruments
- Review copies of translations
- Review copies of user manuals
- Contact information on instruments
- Conditions of use
- List of existing translations
- Concept of interest
- Population for intended use
- Administration mode
- Recall / Observation period
- Time of completion
- Domains covered
- Scoring information
- Content validity documentation
- Measurement properties
What makes PROQOLID™ special
Ensuring the information found in the PROQOLID™ database is not only accurate but also up to date, our staff works in close collaboration with the COA developers before publishing any information online.
Putting PROQOLID™ to work
To subscribe to PROQOLID™, please visit ePROVIDE™
Today, more than ever before, there is great interest in the wording and types of COAs contained within product labels approved by major health authorities.
How PROLABELS™ works
A dedicated team at Mapi Research Trust has reviewed all drug marketing authorizations available since 1995 on the European Medicines Agency’s (EMA) website, and all New Drug and Biological Approvals (i.e., NMEs, BLAs, revisions, and efficacy supplements) on the US Food and Drug Administration’s (FDA) website.
What you’ll learn on PROLABELS™
For each product with a successful COA Labeling Claim, you’ll find:
- Full detail and agency information on labeling claim
- Study design and endpoints
- COAs used and available information on them
Our user-friendly advanced search engine allows you to search by:
- Therapeutic area / indication
- Type of outcome assessments
- COA concepts
- Study endpoints
- COAs (list of all COAs used in a successful labeling claim)
- Marketing authorization holder
- Source agency
- Date of approval/date of claim
Our on-going reviews include all drug approvals, revisions, and withdrawals with weekly updates throughout the year.
Annual subscriptions access
To learn more, visit ePROVIDE™
The aim of the PROINSIGHT™ database is to centralize and summarize published regulatory recommendations concerning the use of clinical outcome assessments (COAs) issued by the FDA, the EMA, The NICE and Health Canada in drug development.
The PROINSIGHT™ database is an option of the PROLABELS™ database and focuses on the same scope: any COA endpoint mentioned in a guidance is detailed and characterized, whatever the method of measure may be: PRO, ClinRO, ObsRO, PerfO.
The following information can be retrieved according to its availability in the source document:
– Guidance Description: Health authority (agency which published the guidance) / Date of publication by the regulatory body / Guidance status (draft, final/adopted) / Therapeutic area / Therapeutic indication / Objective of the guidance / Link to the source document
– Targeted Patient Population:
- For each Technology targeted, the following can be retrieved: Population inclusion criteria / General consideration on efficacy/study design / Statistical considerations / Guidelines for the presentation of the results
- For each concept of interest: Endpoint positioning and definition / Type of Outcome Assessment (OA) / Name of the COA instrument if stated / Type of measure recommended (VAS, NRS, Questionnaire, other, etc) / Rating: for each concept of interest (excluding those representing either biomarkers or survival) a rating provided by our researchers is assigned
– Safety recommendations are also included if available.
– Related Guidance: any guidance published by the other regulatory bodies reviewed in the database for the same indication will be indicated
Our on-going reviews include all new guidance, revisions, and withdrawals with weekly updates throughout the year.
To learn more, visit ePROVIDE™