The Global Initiative

The Foundation is preparing a coordinated program of studies across multiple conditions and multiple countries. The program is designed to accommodate a range of study types, each suited to different scientific questions and stages of evidence. No single design is treated as the default. The appropriate approach for each research question will be selected on scientific grounds and confirmed through ethical, operational, and regulatory review.

The study types under consideration are described below. In practice, a mature research program often combines more than one of these approaches over time, beginning with descriptive or observational work and moving toward more controlled designs as questions become sharper.

Study Types Under Consideration

Real World Evidence Studies

Real-World Evidence studies use data generated during routine clinical care, rather than in the tightly controlled conditions of an explanatory trial. They describe how interventions are used and what outcomes occur in ordinary practice. Their strength is external validity and relevance to everyday settings. Their limitation is that, without careful design and analysis, they are more exposed to confounding than randomized studies.

Pragmatic Clinical Trials

Pragmatic clinical trials test interventions under conditions that resemble routine care while retaining core elements of trial design, such as prospective allocation and pre-specified outcomes. They are intended to inform practical decisions about care. They differ from explanatory trials, which are designed to establish effect under ideal conditions and typically apply narrower eligibility criteria and more intensive monitoring.

Prospective Registries

A prospective registry systematically collects standardized data on a defined population over time, following participants forward from enrollment. Registries are well suited to characterizing natural history, patterns of use, safety signals, and long-term outcomes. They do not, by themselves, establish causal effect, but they provide a structured foundation on which other studies can build.

Observational Research

Observational studies, including cohort and case-control designs, examine associations without assigning interventions. They are valuable for generating hypotheses, describing safety, and studying questions where randomization is not feasible or appropriate. Interpretation requires careful attention to bias and confounding.

Hybrid Research Designs

Hybrid designs combine features of more than one approach, for example embedding a randomized comparison within a registry, or linking a pragmatic trial to real-world data sources for long-term follow-up. These designs can improve efficiency and extend the reach of a study when applied thoughtfully.

Integrated Healthcare Research

Integrated healthcare research studies interventions as they function within a broader model of care, alongside conventional treatment and standard clinical pathways. This approach reflects how integrative therapies are frequently used in practice and helps to assess their role in combination rather than in isolation.

Multi-Center Studies

Multi-center studies enroll participants across several sites, and often several countries, under a common protocol. They improve generalizability, support larger sample sizes, and allow findings to be examined across diverse populations and settings. They require harmonized procedures, central coordination, and consistent quality standards across all participating sites.

The final methodology for any given research question, including the choice among these designs, the endpoints, the sample size, and the analytical plan, will be determined through scientific, ethical, operational, and regulatory review before a study begins.

Disease Portfolio Review and Consolidation

The Foundation received a broad list of candidate conditions for possible study. Several entries on that list describe the same underlying condition using different terms, or describe points along a single clinical continuum. Where conditions share pathophysiology, assessment methods, and patient populations, it is scientifically efficient to organize them into a single research program while retaining the ability to study distinct sub-questions within it.

Consolidation has been applied only where it is scientifically justified. Conditions have not been merged simply because they involve the same organ system. For example, the several gynecological conditions on the list, polycystic ovary syndrome, primary dysmenorrhea, endometriosis, and menopausal vasomotor symptoms, remain separate research programs because their mechanisms, endpoints, and study populations differ materially, even though all fall within women's health.

Fostering healthcare research

by providing public assurance of ethics.