The Primary Endpoint Is Negative

If the primary outcome is negative, positive findings for secondary outcomes are usually considered to be hypothesis-generating. Certainly ...

The Primary Endpoint Is Negative: What Happens Now? - Medscape

In this slide lecture, Stuart J. Pocock, PhD, reviews factors to consider when interpreting a clinical trial that fails to meet its primary endpoint.

Why a Missed Primary Endpoint Isn't the End of the Road

What often happens is argument over whether negative primary endpoint results should be ignored in favor of secondary outcomes.

Interpreting the results of secondary end points and subgroup ...

... negative at the trial's conclusion. Like the 'crazy aunt in the attic,' the negative primary end point receives little attention in the end, is referred to ...

How to avoid concerns with the interpretation of two primary ...

Studies that use an at-least-one concept have been proposed where study success is claimed if superiority for at least one of the endpoints is ...

Clinical trials: design, endpoints and interpretation of outcomes

If a trial has only one primary endpoint and only one analysis of that endpoint is done the alpha level for that one test will match the overall ...

Possible Causes of Failing to Meet Primary Endpoints - PubMed

The median OS in the control arm in negative trials was significantly longer than the pretrial estimate ( P < .001), whereas the median PFS in ...

Full article: 'Negative' Clinical Trials in Rare Diseases and Beyond

Currently, categorizing clinical trials as 'negative' is based solely on the main outcome of the trial without taking into account whether there are other ...

The Primary Outcome Measure and Its Importance in Clinical Trials

Statistical testing of secondary outcomes is associated with an increased risk of both false-positive and false-negative errors. ABSTRACT. The ...

Endpoint Reporting in Medical Journals Needs to Be Revamped

At present, P values are rarely interpreted beyond the binary of classifying endpoints as positive or negative. As an example, Stone cited the ...

The Primary Outcome Fails â - The New England Journal of Medicine

Nevertheless, an unreasonable yet widespread practice is the labeling of all randomized trials as either positive or negative on the basis of ...

Multiple Endpoints in Clinical Trials - Guidance for Industry - FDA

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any ...

Primary Endpoint - an overview | ScienceDirect Topics

If a drug is meant to reduce fever, then Temperature should likely be the primary endpoint in a trial assessing efficacy with it. And if a diagnostic test aims ...

Underpowered or Negative? A closer look at not-so-positive trial ...

A 2016 NEJM review titled 'Primary outcome fails - what's next?' highlighted this issue. Studies where the primary outcome has a p-value over ...

Multiple Endpoints in Clinical Trials Guidance for Industry | FDA

study “wins”) is designated the primary endpoint or primary endpoint ... prespecified primary endpoints, both positive and negative, are considered in the overall.

Negative Results of Randomized Clinical Trials Published in the ...

The randomized controlled clinical trial (RCT) is the definitive method to investigate the relative efficacy of 2 or more interventions of interest. However, ...

'Negative' Oncology Results May Miss Endpoints, But Not Lessons ...

Question: What do trials that do not meet their primary endpoint add to the oncology field? Is there any value to negative trials? Answer ...

PulmCrit Wee- Secondary endpoints: Can we separate the wheat ...

A possible solution to this is as follows: If the primary endpoint is technically “positive” with a borderline level of significance (e.g. p= ...

Choosing primary endpoints for clinical trials of health care ...

Endpoint selection is a complex process. End-users bring differing needs and perspectives. Poor selection of endpoints makes interpretation and implementation ...

How can MRD negativity be used as an endpoint in clinical trials?

Watch the full course and our most up-to-date content here: https://linktr.ee/HealthTreeUniversity Create a free account to track your ...