The placebo response in medicine: minimize, maximize or personalize?

P Enck, U Bingel, M Schedlowski, W Rief - Nature reviews Drug …, 2013 - nature.com
Our understanding of the mechanisms mediating or moderating the placebo response to
medicines has grown substantially over the past decade and offers the opportunity to …

Molecularly targeted cancer therapy: some lessons from the past decade

M Huang, A Shen, J Ding, M Geng - Trends in pharmacological sciences, 2014 - cell.com
The tremendous advances achieved in the understanding of cancer biology have delivered
unprecedented progress in molecularly targeted cancer therapy in the past decade. The fast …

A roadmap to using historical controls in clinical trials–by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG)

M Ghadessi, R Tang, J Zhou, R Liu, C Wang… - Orphanet journal of rare …, 2020 - Springer
Historical controls (HCs) can be used for model parameter estimation at the study design
phase, adaptation within a study, or supplementation or replacement of a control arm …

Cancer biomarkers: selecting the right drug for the right patient

GJ Kelloff, CC Sigman - Nature reviews Drug discovery, 2012 - nature.com
This Perspective highlights biomarkers that are expressed as a consequence of cancer
development and progression. We focus on those biomarkers that are most relevant for …

Leading pharmaceutical innovation

O Gassmann, G Reepmeyer, M Von Zedtwitz - Berlin: Springer. https://doi …, 2008 - Springer
The life sciences have never been an easy industry, and they are about to become even
more treacherous to navigate. New technologies speed up innovation, new competitors …

Orphan drug development: an economically viable strategy for biopharma R&D

KN Meekings, CSM Williams, JE Arrowsmith - Drug discovery today, 2012 - Elsevier
Orphan drug incentives have stimulated research into diseases with significant unmet
medical need. Although the targeting of orphan diseases is seen by industry as an attractive …

Methods for identification and confirmation of targeted subgroups in clinical trials: a systematic review

T Ondra, A Dmitrienko, T Friede, A Graf… - Journal of …, 2016 - Taylor & Francis
Important objectives in the development of stratified medicines include the identification and
confirmation of subgroups of patients with a beneficial treatment effect and a positive benefit …

Biomarker-guided adaptive trial designs in phase II and phase III: a methodological review

M Antoniou, AL Jorgensen, R Kolamunnage-Dona - PloS one, 2016 - journals.plos.org
Background Personalized medicine is a growing area of research which aims to tailor the
treatment given to a patient according to one or more personal characteristics. These …

The risks of risk aversion in drug regulation

HG Eichler, B Bloechl-Daum, D Brasseur… - Nature reviews Drug …, 2013 - nature.com
Drugs are approved by regulatory agencies on the basis of their assessment of whether the
available evidence indicates that the benefits of the drug outweigh its risks. In recent years …

Personalized medicine and pharmacogenetic biomarkers: progress in molecular oncology testing

FS Ong, K Das, J Wang, H Vakil, JZ Kuo… - Expert review of …, 2012 - Taylor & Francis
In the field of oncology, clinical molecular diagnostics and biomarker discoveries are
constantly advancing as the intricate molecular mechanisms that transform a normal cell into …