memo inOncology – Education FUNDAMENTALS OF DESIGNING CLINICAL TRIALS covers aspects of oncological clinical trial design ranging from biomarker and endpoint selection, through to biostatistics and ethics. This series aims to arm oncologists with a detailed insight into oncological trial design.
Fundamentals of designing clinical trials
Part 1: Biomarkers in oncology trials
The Fundamentals series kicks off with an in-depth examination from Silvia Novello and Nik Zeps of how a PI should design, conduct, and implement a biomarker-driven oncology trial. They advise on negotiating the regulatory pathway, and discuss how biomarker screening introduces additional ethical considerations to trial design, as well as the general responsibilities of the principal investigator. Read the report here.
Preface – Part 1
Preface – Part 1 Nik Zeps PhD, St. John of God Health Care Subiaco Hospital, Subiaco, Australia In this special issue related to biomarkers and ethics in oncology trials, international experts have provided their perspectives on the most important elements related to their successful design, conduct and implementation of their results into clinical practice.
Biomarker-based clinical trials: study design and regulatory requirements
Biomarker-based clinical trials: study design and regulatory requirements Introduction Due to the recent developments in the field of molecular diagnosis, it has become evident that there is no such entity as cancer per se, as there are considerable biological differences even within a particular anatomical subtype.
Ethical considerations in clinical trials, and responsibilities of a principal investigator
Ethical considerations in clinical trials, and responsibilities of a principal investigator Introduction Ethics can best be thought of as the moral principles that underpin good behavior. However, how this is defined is open to wide interpretation, and depends on factors such as societal norms and religion.
序文 – Medical Education Clinical Trials Part I
序文 – Medical Education Clinical Trials Part I Nik Zeps PhD, St. John of God Health Care Subiaco Hospital, Subiaco, Australia 親愛なる皆さん、 バイオマーカーおよび腫瘍試験に関連したこの特別号では、国際的な専門家が自らの成功結果のデザイン、運営および実施を臨床診療に関連付ける最も重要な要素についての考え方を提供しています。
バイオマーカーに基づく臨床試験：試験のデザインおよび規制上の要件
バイオマーカーに基づく臨床試験：試験のデザインおよび規制上の要件 はじめに 分子診断の分野では最近の開発により、かなりの生物学的な違いが特定の解剖学的サブタイプの中でさえ存在していることから、癌自体としての存在はないことが明白になった。
臨床試験の倫理的考慮および治験責任医師の責任
臨床試験の倫理的考慮および治験責任医師の責任 はじめに 倫理は、良好な行為を支持する倫理上の原理として最も良いものとみなされ得る。
Part 2: Contemporary designs of phase I and II trials in oncology including endpoint selection and quality of life as an endpoint
Sensible endpoint selection design is a critical part of oncological clinical trial design, and is explored here. This issue looks at the usage of QOL as an endpoint, and discusses the critical aspects of phase I and II trials in turn that should be considered during the design phase.
Read the report here.
Preface – Part II
Preface – Part II Chia-Chi (Josh) Lin, MD, PhD, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan Dear Colleagues Due to the innovations in the field of oncological treatment that have profoundly changed our perception of modern cancer therapy, the design of clinical trials had to be modified appropriately with the purpose of allowing for the assessment of the distinct effects of new drugs.
Phase I trials
Phase I trials Drug development trials are traditionally divided into 3 phases serving different purposes (Table 1).
Phase II trials
Phase II trials Phase II studies provide initial assessment of efficacy in a more homogeneous patient population.
Clinical trial endpoint selection
Clinical trial endpoint selection Endpoint selection is a crucial aspect in the context of clinical trial design.
Quality of life as an endpoint
Quality of life as an endpoint Quality of life (QoL) assessment adds useful information to the efficacy and safety data obtained in clinical studies. It contributes to the evaluation of different treatments and identifies patients who might benefit from supportive interventions.
Part 3: Global perspective on lung cancer: disease management in Brazil & lung cancer research in Asia
This issue shines a spotlight on the global fight against lung cancer. Taking Brazil as an example, the issue looks at the challenges that the rising incidence of lung cancer poses to less developed nations. Turning to Asia, which has the highest percentage of lung cancer patients in the world, the importance of the region in lung cancer research is discussed.
Read the report here.
Part 4: Phase III trial design in oncology and principles of article submission
Phase 3 lung cancer trials are becoming more complex. This issue takes a look at how the lines between phase 2 and phase 3 oncology trials are becoming blurred, and the possible benefits of umbrella and basket trial designs for molecular targets in cancer compared to traditional designs. This issue also considers how biomarkers can affect the design, conduct and analysis of clinical trials. Turning to the peer review process, two articles deal with journal selection and manuscript preparation, as well as the peer review process itself.
Read the report here.
