Inclusion and Exclusion Criteria

Last updated: 2026-03-27

Overview

The ALIGN Global Hub maintains a structured registry of health products and innovations. This document outlines the criteria used to determine which products and databases are included in the platform.

Product Inclusion Criteria

To be included in the Global Hub, a health product must meet the following criteria:

1. Disease Area

The product must target one or more of the following high-priority disease areas:

HIV/AIDS
Tuberculosis (TB)
Malaria
Maternal, Newborn, and Child Health (MNCH)

2. Development Stage

The Hub focuses on products that are in advanced development or already available in the market. A product is typically included if it has reached:

Phase 2 Clinical Trials or later.
Not have achieved Market Authorization in at least one of the partner countries (Senegal, South Africa, or Kenya).

3. Innovation Category

The Hub tracks innovations across several categories: - Diagnostics (e.g., assays, point-of-care tests) - Therapeutics (e.g., drugs, biologics) - Vaccines - Vector-Controlled Products (e.g., bed nets, indoor residual spraying) - Medical Devices

Product Exclusion Criteria

Products are excluded from the Hub if:

They target diseases outside the scope of ALIGN (e.g., non-communicable diseases not related to MNCH).
They are in the very early stages of development (Preclinical or Phase 1), unless they represent a major technological breakthrough.
Development has been officially terminated or “on hold” for more than 5 years without update.

Database Selection Criteria

ALIGN integrates multiple external databases to provide a comprehensive view of the landscape.

Inclusion Rationale

Databases are selected based on:

Relevance: High coverage of the priority disease areas.
Credibility: Maintained by reputable global health organizations, regulatory bodies, or research institutions.
Data Structure: Availability of structured data (API, CSV exports) that allows for automated or semi-automated integration.
LMIC Focus: Preference for databases that provide signals relevant to Low- and Middle-Income Countries (LMICs).

Exclusion Rationale

Databases may be excluded if:

They require high-cost proprietary licenses that limit public dissemination.
The data is excessively fragmented or lacks sufficient identifiers (e.g., manufacturer name, product name) to allow for deduplication.
The source has not been updated for more than 2 years.

Update Frequency

The inclusion status of products is reviewed quarterly as part of the data integration pipeline. If a product no longer meets the criteria (e.g., development is discontinued), it is marked accordingly in the database.

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