Challenges in early phase development oncology 17 nov2013
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The challenges of early cancer drug development have increased in complexity over time. Previously, drugs were nonselective cytotoxics with simple administration, but now drugs are molecularly targeted with more complex schedules and trials. Phase 1 studies of targeted agents require consideration of optimal dose, schedules, patient selection based on biomarkers, and incorporation of pharmacokinetic/pharmacodynamic analyses. Phase 2 studies increasingly involve randomized designs, combination treatments, biomarker analyses, and collection of tumor samples. Managing this complexity requires thorough preclinical data, early companion diagnostic and biomarker assay development, predefined go/no-go criteria, and clinical development plans to guide subsequent studies.
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Screening
Screening is a tool used to identify undiagnosed cases of disease in a population using rapid tests. The objectives of screening are to reduce mortality and morbidity through early detection and treatment, and to maintain or enhance production through better disease management. Screening aims to separate healthy individuals who likely have a disease from those who do not, though a positive screening test requires more diagnostic testing. Effective screening involves both diagnostic testing and treatment components, and aims to identify existing disease in asymptomatic individuals. The only valid measure of a screening program's effectiveness is its impact on disease-specific mortality rates.
Phase I trials - Educational course at the PAMM-2019 winter meeting
Phase I trials - Educational course at the PAMM-2019 winter meetingProf. Eric Raymond Oncologie Medicale
This presentation was made at the PAMM winter meeting in Verona (Italy) February 2019 and intended students to go through the basic methods used for phase I clinical trials.Clinical Trial phases.pptx
Clinical trials are generally conducted in four phases:
1) Phase I trials test safety in healthy volunteers and determine safe dosage.
2) Phase II trials study efficacy in small patient groups to identify effective dosages.
3) Phase III trials test efficacy versus standard treatment in large patient groups.
4) Phase IV trials collect additional safety and efficacy data after approval and commercialization.
Soil_ Erosion.ppt
This document provides an overview of the clinical trial process. It describes the types of clinical trials including treatment, prevention, screening, and diagnostic trials. It outlines the four phases of drug development and the roles of various players like physicians, nurses, and data managers. It discusses how clinical trials are highly regulated to protect human subjects, the importance of informed consent and institutional review boards. Key aspects of clinical trials like developing a research protocol, recruiting patients, collecting subject data, reporting adverse events, and analyzing results are also summarized.
Clinical Trial Process.ppt
This document provides an overview of the clinical trial process. It describes the types of clinical trials including treatment, prevention, screening, and diagnostic trials. It outlines the four phases of drug development and the roles of various players like physicians, nurses, and data managers. It discusses how clinical trials are highly regulated to protect human subjects, the importance of informed consent and institutional review boards. Key aspects of clinical trials like developing a research protocol, recruiting patients, collecting subject data, reporting adverse events, and analyzing results are also summarized.
Clinical trial phases, requirements and regulations
An intensive overview of various phases of clinical trial, their aims & objectives with various characteristics of each phase
Dept. of Food Safety and Zoonoses (FOS)
Kate Z. Guyton PhD DABT - Senior Toxicologist - Responsible Officer, Volume 112 - Monographs Programme
Clinical trails
Clinical trials are conducted in phases to evaluate the safety and efficacy of new drugs. Phase 1 trials involve 10-20 healthy volunteers to determine toxicity and pharmacokinetics. Phase 2 trials involve 100-200 patients to identify effective doses and further evaluate safety. Phase 3 trials involve up to 1000 volunteers to study less common side effects, compare to standard treatments, and evaluate long-term safety and effectiveness. Phase 4 trials monitor drugs after approval in 5000-10,000 patients to identify rare or long-term issues.
Clinical Trial Presentation-6.29.15-cg
This educational webcast discusses clinical trials and their role in advancing research for inflammatory bowel diseases (IBD). It provides an overview of the clinical trial process, including the different phases from pre-clinical research to FDA approval. Common features of IBD clinical trials are reviewed, such as endpoints of symptom improvement and reduction of inflammation. Resources for learning more about participating in clinical trials through organizations like CCFA and ResearchMatch are presented.
Clinical research basic things
This document provides an overview of clinical research and clinical trials. It defines clinical research and clinical trials, discusses the importance of research. It describes the different types and phases of clinical trials, from phase 0 to phase IV. It outlines the key players involved in clinical trials and provides an overview of the clinical trial process from study design to statistical analysis and reporting.
Drug and safety monitoring board
The document discusses data and safety monitoring boards (DSMBs), which regularly review accumulating data from ongoing clinical trials to monitor safety and scientific validity. A DSMB is typically appointed by the trial sponsor. The document outlines factors in determining if a trial needs a DSMB, how DSMBs are composed, their responsibilities like monitoring safety and effectiveness, and how they make recommendations to sponsors. Not all trials require independent external DSMBs, but all should have a data safety monitoring plan to protect participants.
DATA AND SAFETY MONITORING BOARD.pptx
The document discusses the purpose and operations of a Data Safety Monitoring Board (DSMB). A DSMB regularly reviews accumulating data from ongoing clinical trials to monitor safety and efficacy. It advises the sponsor on risks to current and future subjects. Key responsibilities include monitoring trial conduct, safety, effectiveness, and making recommendations to modify or terminate trials early if necessary. DSMBs are typically composed of experts in relevant clinical specialties and biostatistics who do not have conflicts of interest in the trial.
Engaging multidisciplinary teams in translational research and quality improv...
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The Sydney West Translational Cancer Research Centre is a five year program grant funded by the Cancer Institute NSW aimed at improving patient outcomes through translational research. Multidisciplinary teams (MDTs) are key to the delivery of cancer care in Australia. There is a lack of knowledge and research into how these MDT teams can best be engaged in translational research from basic science through to implementation science and quality improvement. Concepts of Screening for disease
This document discusses screening and the "iceberg phenomenon of disease". It defines screening as testing apparently healthy individuals to detect unrecognized disease. Much disease exists below the surface, including subclinical cases, carriers, and undiagnosed cases, constituting a large reservoir of undiagnosed disease in the community. Effective screening aims to sort healthy from diseased individuals to provide early treatment and control disease prevalence. Screening tests should be accurate, cost-effective, and acceptable while balancing risks and benefits.
Research on consequences of cancer and its treatment on quality of life, symp...
Susanne Oksbjerg Dalton, Group Head, consultant, Danish Cancer Society Research Center, Danish Cancer Society, presentation at the Second International Scientific and Practical Conference «Improving the quality of life of cancer patients through the development of cooperation between state, commercial and non-profit organizations». 2018-01-23, Minsk. Belarus.
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An Introduction to Cinical Trials for Metastatic Breast Cancer Patients
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The Investigational New Drug (IND) and New Drug Application (NDA) Process
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SHARE Webinar: Why Should I Join a Clinical Trial with Dr. Hershman
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Phase I trials - Educational course at the PAMM-2019 winter meeting
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Introduction
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https://www.productmanagementtoday.com/frs/26903918/understanding-user-needs-and-satisfying-them
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Best practices for project execution and delivery
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Challenges in early phase development oncology 17 nov2013
- 1. Challenges in Early Cancer Drug Development Q: What are the biggest challenges you see facing early development oncology and how could you become part of the solution?
- 2. Increasing Complexity Then (1991) • Nonselective cytotoxics • Simple administration & schedule (eg, IV Q3W) • Single arm early phase trials Now (2013) • Molecularly targeted • IV or oral, multiple schedules • More complex trials in targeted populations
- 3. Phase 1 Studies Nonselective Cytotoxic Targeted Agent • • Standard 3+3 design – Determine MTD • Toxicity drives RPIID selection – “All comers” advanced, refractory disease – Limited BA assay development – IV administration, simple schedule (eg, IV Q3W) Standard 3+3 design – Determine MTD? • Non- or less toxic agents • PK/PD may drive RPIID selection – Targeted or “enriched” tumor subtypes? – Companion diagnostic, Robust PD assay(s) – IV or oral, QD, BID, Intermittent, etc. • Real time PK and preclinical models may help to suggest the right schedule
- 4. Phase 2 Studies • Cytotoxic • ORR • • • S R Brown, W M Gregory, C J Twelves, et al. British Journal of Cancer (2011) 105, 194–199 More randomized studies – Time to event endpoints – Combination treatments – Dose selection (high vs. low dose) Patient selection based on marker expression Central pathology and radiology reviews Population PK and PD/Biomarker analyses – Collection of tumor/surrogate tissue samples for correlative analyses
- 5. Phase 2 Studies 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% Phase 2 Cancer Trial Publications (PubMed) % Randomized % Randomized Industry Sponsored Phase 2 Interventional Cancer Trials in Adults and Seniors - Clinicaltrials.gov 45% 40% 35% 30% 25% 20% 15% 10% 5% 0%
- 7. Increasing Complexity • Better science. • Better medicines. • Better trials.
- 8. Managing Complexity • More pre-clinical data before Phase 1 can be helpful – Guide dose schedule (not just starting dose) – Identify tumor types more likely to respond or harbor marker of interest • Initiate companion diagnostic and PD assay development early • Establish go/no-go criteria for Phase 2 – Acceptable safety profile, Target blood levels, Indications of drug activity • Prepare Clinical Development Plan early – Next study can be developed during FIM Phase 1 study • Consider how increased clinical trial complexity affects study execution – More PK/PD sampling = more lab kits, more coordination, more data – Phase 1 development may be more extensive if multiple schedules or combinations need to be explored – Randomized Phase 2 trials require more time to plan and resources to conduct – High quality data (Safety, Efficacy, PK, PD) are needed for decision making
- 9. Managing Complexity • Successful drug development has always been an endeavor involving capable individuals working together collaboratively in teams.