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ESMO Clinical Trials Tips and Tricks

Practical tips to assist you in your day-to-day clinical trial research

The short presentations below aim to assist you in defining, running and reporting your clinical trial.

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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)

While every effort has been made to contact the copyright holders of all images, the publisher would be grateful for any additional information about any images where they have been unable to trace or obtain permissions and will be glad to make amendments in future editions.

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