The short presentations below aim to assist you in defining, running and reporting your clinical trial.
New resources are added on a regular basis. Check for recent updates!
Principles of Clinical Trials and Systemic Therapy
Resources from ESMO Congress 2016
Introduction – Christian Dittrich
Under-reporting of harm in clinical trials – Alberto Ocana Fernandez
Unplanned versus pre-specified subgroup analysis reporting – Doug Altman
Quality of meta-analyses and why they sometimes lead to different conclusions – Jean-Pierre Pignon
Early reporting of efficacy endpoints and its potential impact: Biostatistical part – Jan Bogaerts
Early reporting of efficacy endpoints and its potential impact: Clinical part – Fatima Cardoso
Conclusions – Denis Lacombe
Defining your clinical trial
Basket Trials. A well-used format of master protocols in modern drug development - Christian Dittrich, Nadia Harbeck and Christoph Benedikt Westphalen (2020)
Brain Metastases - Silvia Hofer and Nuria Kotecki. (2020)
Molecular imaging: contribution to personalised oncology – Alain Hendlisz and Patrick Flamen. (2019)
Regulatory oncology drug approvals based on the new clinical research landscape – Urania Dafni, Zoi Tsourti, Panagiota Zygoura, Alex A. Adjei, Dirk Arnold, Ahmad Awada, Christian Dittrich, Denis Lacombe, Paul Morten Mau-Sørensen. (2019)
Molecular tumour boards and precision cancer medicine – Dirk Arnold, Benedikt Westphalen, Ian Tannock. (2019)
Biosimilars: ensuring clinical efficacy and safety – David Holt (2018)
Oligometastatic disease: a true clinical entity in oncology? – Yazid Belkacemi, Nicolas Penel (2018)
The twenty Lessons learnt from the development of molecular-targeted therapies – Nuria Kotecki, Guillem Argilés, Ahmad Awada (2017)
Pharmacological aspects of clinical trials – Alex Adjei, Emiliano Calvo, Anita Margulies, Josep Tabernero, Ian Tannock (2017)
Drugs development methodology: the unavoidable break with the past – Ahmad Awada, Nuria Kotecki, Alex Adjei, Guillem Argiles, Dirk Arnold, Jean-Yves Blay, Olivier Collignon, Christian Dittrich, Felip Janku, Denis Lacombe, Nicolas Penel, Josep Tabernero (2017)
Lessons learnt from the development of cytotoxics and perspectives – Nicolas Penel, Yazid Belkacemi, Emiliano Calvo, Fatima Cardoso, Christian Dittrich, Stefan Sleijfer (2017)
Overview of drug development and types of clinical trials – Denis Lacombe, Anita Margulies, Jan Tannock, Jan Bogaerts and Christian Dittrich (2015)
What to consider when deciding to participate in a trial as an investigator – Jean-Yves Blay and Emiliano Calvo (2015)
Pathological Aspects of Clinical Trial – Christoph Röcken (2016)
What to consider when designing a trial – Ulrich Keilholz, Dirk Arnold, Susen Burock, Emiliano Calvo, Urania Dafni, Nadia Harbeck, Eric Raymond, Piotr Rutkowski, Marcel Verheij (2016)
Innovative clinical trial designs in the era of precision oncology – Ahmad Awada, Hampig Raphael Kourie, Jean-Yves Blay, Nadia Harbeck, Paul Morten Mau-Sørensen, Stefan Sleijfer (2016)
Running your clinical trial
Prostate cancer: Molecular biology and influence on clinical trials design in the era of precision medicine - Nieves Martínez Chanzá, Irene Moreno Candilejo, Karima Oualla (2021)
Circulating Tumour DNA in Cancer - Michail Ignatiadis, Guillem Argiles, Emiliano Calvo, Arnold Dirk, Alain Hendlisz, Filip Janku, Morten Mau-Sorensen, Patrick Pawels, Stefan Sleijfer, Ahmad Awada (2020)
The value of PD-L1 expression as predictor of benefit with immune checkpoint inhibitors – Ahmad Awada, Luis Castelo-Branco, Emiliano Calvo, Irene Moreno, Karima Oualla, Ines Pires da Silva, Francesco Sclafani. (2019)
How to manage residual oligometastatic disease following induction therapy in solid tumours – Piotr Rutkowski, Peter Hohenber, Ahmad Awada (2018)
Challenges with immune checkpoint inhibitors – L. Castelo-Branco, A. Awada, A.Adjei, S. Aspeslagh, E. Calvo, H. Canhão, N. Kotecki, N. Penel (2018)
Clinical trial endpoints – Ian Tannock, Steinar Aamdal, Dirk Arnold, Urania Dafni, Ulrich Keilholz, Paul Morten Mau-Sørensen, Piotr Rutkowski, and Stefan Sleijfer (2015)
Informed consent – Thomas Cerny, Jan Geissler, and Marie-Christine Hollerith (2015)
PRO assessment in cancer trials – Emiliano Calvo, Anita Margulies, Eric Raymond, Ian Tannock, Nadia Harbeck and Lonnekevan de Poll-Franse (2016)
Reporting and interpreting results
Lessons learnt from the development of immunotherapy - S. Aspeslagh, A. Awada, E. Calvo, S. Coupland, S. Sleijfer (2018)
The ESMO-Magnitude of clinical Benefit scale v1.1. User instructions and ESMO-MCBS case studies – Elisabeth de Vries, Nathan Cherny and Nicola Latino (2017)
Understanding clinical trials statistics – Urania Dafni, Xanthi Pedeli, and Zoi Tsourti (2015)
Interpretation of Clinical Trials – Alberto Sobrero (2016)
Reporting side effects of therapy from early and pivotal clinical trials and definition of recommended doses – Ahmad Awada, Hampig Raphael Kourie, Christian Dittrich (2016)
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