A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies
ND Modi, G Kichenadasse, TC Hoffmann, M Haseloff… - BMC medicine, 2023 - Springer
Data sharing is essential for promoting scientific discoveries and informed decision-making
in clinical practice. In 2013, PhRMA/EFPIA recognised the importance of data sharing and …
in clinical practice. In 2013, PhRMA/EFPIA recognised the importance of data sharing and …
[HTML][HTML] Objective response rate and progression-free survival as surrogates for overall survival treatment effect: A meta-analysis across diverse tumour groups and …
A Shahnam, N Hitchen, U Nindra, S Manoharan… - European Journal of …, 2024 - Elsevier
Background Overall survival (OS) results from randomized control trials (RCT) provide the
strongest evidence for efficacy of anti-cancer treatments but can take a considerable amount …
strongest evidence for efficacy of anti-cancer treatments but can take a considerable amount …
On Enhancing Clinical Trial Data Sharing
M Buyse - JAMA oncology, 2023 - jamanetwork.com
The authors1 stress the progress that has been realized over the past decade to make
sharing of IPD possible. It is worth noting that some of the authors have played a key role in …
sharing of IPD possible. It is worth noting that some of the authors have played a key role in …
Journal requirement for data sharing statements in clinical trials: a cross-sectional study
J Zhang, Y Liu, L Thabane, J Li, X Bai, L Li… - Journal of Clinical …, 2024 - Elsevier
Abstracts Objective Data sharing statements are considered routine in clinical trial reporting,
and represent a step towards data transparency. The International Committee of Medical …
and represent a step towards data transparency. The International Committee of Medical …
A lack of association between BMI and chemoimmunotherapy efficacy in advanced non-small cell lung cancer: Secondary analysis of the IMpower150 and …
LX Li, MA Socinski, G Kichenadasse, CS Karapetis… - BMC cancer, 2024 - Springer
Background Multiple studies have indicated that patients with high body mass index (BMI)
may have favourable survival outcomes following treatment with an immune checkpoint …
may have favourable survival outcomes following treatment with an immune checkpoint …
Clinical Study Report and Individual Participant Data Transparency for US Food and Drug Administration-Approved Anticancer Drugs: A Call for Systematic Data …
Unlocking the full potential of clinical trials through comprehensive CSR and IPD sharing
can revolutionize cancer care, enhance safety evaluations, and reduce bias in systematic …
can revolutionize cancer care, enhance safety evaluations, and reduce bias in systematic …
[HTML][HTML] Clinical relevance of reports on early access programs for checkpoint inhibitors in cancer patients: a French retrospective nationwide cohort study
Background To accelerate access to new drugs, France operated an early access program
known as Temporary Authorizations for Use (ATUs) until 2021. We analyzed clinical reports …
known as Temporary Authorizations for Use (ATUs) until 2021. We analyzed clinical reports …
Is full transparency in clinical trials an achievable goal?
R Dal-Ré - European Journal of Internal Medicine, 2024 - ejinme.com
In the last two decades several requirements have been developed to enhance clinical trials
transparency. Some are encouraged or recommended by ethics codes, journal editors, or …
transparency. Some are encouraged or recommended by ethics codes, journal editors, or …