ISSUE: Concerns regarding publication bias and inadequate reporting of study design methodology risk undermining the value provided by health economics and outcomes research (HEOR) studies -be they observational; economic models or health economic evaluations.

OVERVIEW: In the clinical trial and systematic review literature, and more recently in the observational study field, registering the study at the protocol phase is well established or growing. Trial registries were created to foster transparency and to tackle publication bias -where only studies with positive findings are more likely to advance to publication- which impedes an accurate view of the global evidence.

In HEOR Research we deal additionally with different designs:

exploratory or confirmatory observational – the latter including Hypothesis-Evaluating Treatment Effectiveness (HETE) studies (whether or not it is based on big data), economic models, and health economic evaluations -both those based in models or on individual patient data.

There is some evidence of publication bias in these types of studies, and there are also critiques regarding the transparency of these designs, including that many studies are the results of “fishing expeditions”, where only studies with positive results advance to publication. A recent ISPOR-ISPE RWE Special task force recommends prospective registration of HETE observational studies. The 2nd US Cost-effectiveness Panel also recommends CEA protocols. The current issue panel tries to set the scene regarding the rationale and history of study registries -their pros and cons; and also, on discussing the timeliness and usefulness of promoting specific registries or transparency models for observational studies -either confirmatory or exploratory; health economic evaluations – trial- or model-based and in the Health Technology Assessment world. Most of the Issue Panel time will be devoted to discussion on key issues. Barriers and facilitators of implementing more or less compulsory registration of these type of study protocols in registries will also be discussed.