Shifting perspectives on the value of non|OS endpoints and PROs

Shifting perspectives on the value of non-OS endpoints and PROs

Results: Non-OS endpoints address some concerns with OS as they can be captured earlier in trials and may act as surrogates of OS; show reduced ...

Beyond overall survival: Time to agree on the value of alternative ...

However, alternative oncology-relevant endpoints beyond OS offer great potential for supporting faster and more efficient access to therapies.

Program Guide – ASCO Meeting Program Guide

Shifting perspectives on the value of non-OS endpoints and PROs: Considerations across stakeholder groups to support oncology HTA decision-making. The ...

Program Guide – ASCO Meeting Program Guide

Shifting perspectives on the value of non-OS endpoints and PROs: Considerations across stakeholder groups to support oncology HTA decision- ...

Quantitative Approaches to Therapeutic Decision Making in ...

Sequencing Treatments in Hepatocellular Carcinoma: Will Value ... Shifting perspectives on the value of non-OS endpoints and PROs: Considerations across ...

Beyond overall survival: Time to agree on the value of alternative ...

Cimen, A., et al., Shifting perspectives on the value of non-OS endpoints and PROs: Considerations across stakeholder groups to support oncology HTA decision- ...

Clinical endpoints in oncology - a primer - PMC

Additionally, as a primary clinical endpoint, OS can also be influenced by non-cancer deaths since the endpoint is defined as time from randomization to death ...

Improving the understanding, acceptance and use of oncology ...

Oncology-relevant endpoints include OS, other clinical endpoints and PROs that capture outcomes of high importance in a given cancer type. •. The value of ...

Significance of emerging clinical oncology endpoints in...

However, the quantum of time involved in assessing OS in a clinical trial setting often renders it unfeasible for regulatory approval. Hence, surrogate ...

Relevant Endpoints in HTA Body / Payer Decision-Making

Conclusions: Clinicians, patients and regulators recognize the value of OREs beyond OS but HTA bodies/payers can be skeptical, driven by concerns about how ORE ...

The Impasse on Overall Survival in Oncology Reimbursement ...

In some cases, we see that regulators, clinicians and patients place different values on non-OS endpoints from payers.,, This can lead to ...

Endpoints in clinical trials for liver cancer and their value in evidence ...

Several modifications to this approach have been proposed to speed up clinical development, but these are beyond the scope of this opinion piece. Obviously, ...

The importance of appropriate selection of clinical endpoints in ...

Clinical trial endpoints must be carefully and intentionally selected so that the results of the trial can be used to inform policy- and ...

Patient-reported outcomes in breast cancer FDA drug labels and ...

In breast cancer, patient perspectives and PROs are particularly important. ... PROs as exploratory endpoints. These ... non-primary endpoints [47].

THE EVOLVING VALUE ASSESSMENT OF CANCER THERAPIES:

Additional oncology-relevant endpoints (beyond OS) that are often used in early-stage cancer could include those listed below; the following are ...

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

Utilities attempt to quantify the desirability or value of an outcome or health state, and specifically how much better/worse one is over another [32].

Multiple Endpoints in Clinical Trials Guidance for Industry | FDA

... endpoints for which the endpoint's p-value is. 1010 less than α /m. Thus, with two endpoints, the critical alpha for each endpoint is 0.025, with four. 1011.

Patient Understanding of Oncology Clinical Trial Endpoints in Direct ...

This study examined how people interpret overall survival (OS), overall response rate (ORR), and progression-free survival (PFS) endpoints in ...

Guidance for Industry:Patient-Reported Outcome Measures - FDA

Common Reasons for Changing Items during PRO Instrument Development ... values for the PRO ... PROs in a clinical trial, like non-PRO clinical endpoints, can be ...

How Are PRO Measures Used? - Rethinking Clinical Trials

PROs play a significant role as study endpoints in the development and evaluation of new therapies (Willke et al. 2004; Gnanasakthy et al. 2016; Gnanasakthy et ...