This webinar covers the study assessing sponsor and CRO experience, practices and improvement areas associated with investigative site identification, feasibility, selection and study startup.
Presenters: Naor Chazan, Director of Marketing (but no longer with the company, FYI) and Sandra “SAM” Sather, Quality and Regulatory, TrialConsent) CRF Health's State of eConsent 2017 Report surveyed 100 biotech, pharmaceutical, CRO, and IRB organizations who shared their opinions on Electronic Informed Consent (eConsent). During this webinar, industry expert, Sandra "Sam" Sather, Regulatory and Quality Lead for TrialConsentTM at CRF Health, discusses the results.
The number of oncology clinical trials has increased exponentially in recent years, putting ever more pressure on increasing clinical trial efficiency by reducing costs and timelines. Patient recruitment swallows 40% of trial costs, yet only 10–17% of studies enroll on time and approximately 11% of sites in any given study fail to enroll a single patient.
Recent successes in the treatment of cancer have led to more complex trials such as master protocols using basket (or bucket) and umbrella designs. These combination designs, with or without cancer immunotherapy treatments, require careful deliberations to optimize dosages and include multiple tumor types in expansion cohorts. Making informed decisions in study design for your basket/bucket or umbrella trials requires relevant and timely evidence-based data.
Predictive and pharmacodynamic biomarkers are a critical component of today’s progress in immuno-oncology (IO) drug development. While predictive biomarkers can accelerate development by identifying the right group of patients to target and ensuring safety and efficacy of the compound, there are inherent challenges in finding and validating biomarkers that will end as companion diagnostics. Pharmacodynamic markers are very useful in early stages of development to help identify the true mechanism of action in humans. The straightforward approach to find and apply these types of markers is more complex in IO.
Many researchers have complained that use of different local IRBs to review each research site for a multicenter trial is extremely inefficient and leads to additional cost burdens and trial delays. Despite this, many US research sites have been hesitant to use a single, central IRB. Is there a substantive difference, in terms of efficiency and effectiveness, between reviews conducted by decentralized (local) and centralized IRBs? What are the pros and cons of each? Are local IRBs really even necessary, or do they just create bottlenecks in modern clinical trials? The webinar will focus on these issues and look at study startup metrics associated with IRBs.
Clinical supply models need to provide for an adequate supply of patient kits that allow for variations in patient recruitment levels and clinical site activity.
Do you face the challenge of recruiting and retaining rare disease patients for orphan drug clinical trials? Now, discover how you can boost participation, enhance outcomes and speed drug development in this competitive market. Join Dr. Rolando Gutierrez-Esteinou, MD, Vice President, Therapeutic Area Head, Neuroscience Medical and Scientific Services at Covance, for this timely Webinar.
Do you face the challenge of recruiting and retaining rare disease patients for orphan drug clinical trials? Now, discover how you can boost participation, enhance outcomes and speed drug development in this competitive market.
This webinar includes tips to help quality, project management, clinical, and site personnel manage conflicts as well as a review of the applicable regulations and reporting requirements.
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