The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.
|Articles|September 17, 2020
- Applied Clinical Trials-09-01-2020
- Volume 29
- Issue 9
ACT Online
A compilation of ACT's most popular content from the previous month plus a look at upcoming webcasts.
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How Does FSP Models Complement eSource Implementation?
A Competency-Based Approach to Combating the Talent Wars in BioPharma
Key Points to Success in Decentralized Alzheimer’s Diagnostic Clinical Trial
Adapting Monitoring Models During COVID-19
Decentralized Trials: Opening New Opportunities in Clinical Research
eLEARNING:
Prioritizing in the New Normal
Throughout the global COVID-19 pandemic, clinical research activity has morphed and changed through the shut down and eventual reopening of research sites and studies. During this webcast, experts will discuss how to prioritize in this “new normal”, whether that involves reopening sites, catching up on a backlog of work, or fully implementing remote capabilities. In addition, we plan to discuss some of the important aspects of clinical trial management from a sponsor/CRO level and what mindset shifts may need to occur to proactively create study plans. A few areas of focus will include resuming activity for ongoing studies, planning upcoming studies, and adjusting budgets for sites and CRO teams.
Information Systems in Clinical Trials: Pragmatic Validation of EDC Systems
Computer System Validation is a key regulatory requirement and one which challenges the understanding and resources of many research organizations. Achieving the validated state means managing an ever-changing environment of servers, operating systems, EDC software, security patches etc, some or all of which may be outside the direct control of the organization. And all this needs consideration before you have even started developing your study database. GCP expects a risk-proportionate approach, but how can this be approached pragmatically? During this webcast, experts will explore the scope of EDC system validation and offer practical ways of dealing with change overload and surviving a visit from the inspectors.
The Future of Precision Medicine: How Biomarkers Have Influenced Clinical Trial Designs and Outcomes
Precision medicine has proven to be successful in treating cancers as it is tailored to a patient’s specific needs. Because of this custom approach to treatment, however, planning a clinical trial for precision medicine is markedly more challenging than more conventional treatments, as it must consider patients’ variability in genes. As a result, biomarker use in precision medicine has been critical for defining patient segments, selecting trial locations, and measuring trial success.
Articles in this issue
about 6 years ago
News Notesabout 6 years ago
Innovative Clinical Trial Designs Emerge from Pandemicabout 6 years ago
Applying Pre-Pandemic Benchmarks to Assess Future Speed Strategiesabout 6 years ago
Silver Linings of Post-Pandemic Trial Disruptionabout 6 years ago
Debate Accelerates Over Who Gets COVID Vaccine Firstabout 6 years ago
FDA’s ‘Gold Standard’ Critical for Biopharma R&Dabout 6 years ago
Decentralized Trials: Opening New Opportunities in Clinical Researchabout 6 years ago
The Rise of FSP Outsourcing in Drug Developmentabout 6 years ago
Trial Innovation Beyond the COVID-19 PandemicAdvertisement
Related to this article
Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, describes the industry’s trajectory toward a unified intelligence orchestration environment—and explains why the future isn’t one model that knows everything, but a trusted system that brings the right evidence to the right human decision.
In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.
Pacing obesity trial enrollment, anchoring eligibility to stable real-world therapies, and building site and physician relationships improve retention and data quality more than aggressive recruitment or restrictive exclusion criteria do.
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, argues that CROs must act as orchestrators rather than aggregators—and that the real test of any AI ecosystem is whether it reduces sponsor coordination burden or just hands it back to them.
Syneos Health and Optum outline a joint model for trial planning, recruitment and site access, with no financial terms or timelines disclosed.
AstraZeneca and Oracle Outline AI Collaboration for Clinical Trial Recruitment and Safety Monitoring
What sponsors and sites should know about the AstraZeneca-Oracle AI collaboration on trial recruitment, safety monitoring and data governance.
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