An overview on new anticancer drugs approved by food and drug administration: impending economic and environmental challenges

MR Sarfjoo, A Shad, M Hassanpour… - Materials Chemistry …, 2022 - mch.du.ac.ir
One of the leading causes of death worldwide these days is cancer, and new anticancer
drugs have been developed to treat it with all the vigor of advancement of science and …

Rethinking placebos: embracing synthetic control arms in clinical trials for rare tumors

C Serrano, S Rothschild, G Villacampa, MC Heinrich… - Nature medicine, 2023 - nature.com
Rethinking placebos: embracing synthetic control arms in clinical trials for rare tumors | Nature
Medicine Skip to main content Thank you for visiting nature.com. You are using a browser …

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 …

Heterogeneity and utility of pharmaceutical company sharing of individual-participant data packages

AM Hopkins, ND Modi, AY Abuhelwa… - JAMA …, 2023 - jamanetwork.com
Importance The pharmaceutical industry has made substantial investments in developing
processes for sharing individual-participant data (IPD) from clinical trials. However, the utility …

Philosophy of Cancer Theranostics

JH Turner - Cancer Biotherapy & Radiopharmaceuticals, 2023 - liebertpub.com
Imagine a theranostic nuclear physician oncologist engaged in a Socratic philosophic
dialogue. Questions that may be posed include the status of our current knowledge base of …

Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation

AM Hopkins, ND Modi, FW Rockhold… - Journal of Clinical …, 2024 - Elsevier
Abstract Objectives Clinical study reports (CSRs) are highly detailed documents that play a
pivotal role in medicine approval processes. Though not historically publicly available, in …

[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 …

[HTML][HTML] Derivative survival analyses: Analysis methods to derive survival outcomes for the remainder patient cohort without individual patient data

NK Shenoy - Cell Reports Medicine, 2024 - cell.com
It is not uncommon for industry-sponsored randomized controlled trials to publish survival
curves/data for the overall patient cohort (" A+ B") and for a favorable subgroup (" A") pre …

Pro-con debate: interdisciplinary perspectives on industry-sponsored research

DI Sessler, B Alman, MM Treggiari… - Anesthesia & …, 2023 - journals.lww.com
Pro: Nearly all new devices and drugs come from industry that provides two-thirds of the
funding for medical research, and a much higher fraction of clinical research. Realistically …

Civil society and medical product access in Africa: Lessons from COVID-19

JL Wale, K Sehmi, R Kamoga… - Frontiers in Medical …, 2023 - frontiersin.org
Understanding health as a human right creates a legal obligation on countries to ensure
access to timely, acceptable, and affordable health care. We highlight the importance of a …