Technology - Advarra

Q&A Part 1 – Evaluating Payment to Participate in Research: Ethical and Regulatory Issues

In a recent webinar, Dr. Luke Gelinas, IRB Chair at Advarra, provided a framework for evaluating offers of payment to research participants. In addition to outlining the challenging ethical and regulatory issues and offering key regulatory guidance, he also provided hypothetical “case studies” to highlight challenging ethical and regulatory aspects of paying research participants. More than 1,000 clinical research professionals joined us for the webinar, which was followed by an engaging Q&A session. Below, Dr. Gelinas answers audience questions we weren’t able to address during the webinar. In the weeks ahead, we will publish part two of his responses, addressing additional questions from webinar attendees.

Protocol Feasibility to Promote Trial Efficiency

Scientific abstracts and articles have reported that 20-50% of studies do not accrue subjects at the site level (1-6). This contributes to a significant amount of waste in clinical research, particularly in the forms of staff time and monetary resources. Such waste can be reduced through the careful selection of clinical trials to activate early in the process, before investing a lot of resources. The protocol feasibility review process achieves this by providing a method to review the logistical aspects of a clinical trial prior to starting the activation process.

Study Activation: A Complex Process That Doesn’t Have to Be Painful

Study activation data from the Forte community shows on average, it takes about six months to activate a new, interventional, treatment clinical trial. Long activation periods are not a new trend – in 2008, Dr. David Dilts’ findings showed it took hundreds of steps to activate an NCI-funded trial at a single site. This was just to get the study open to accrual, not to conduct the study. He also found that not all steps added value to the process. To make his point, he charted the study activation process and when he was done, it was 50 feet long by 5 feet tall and in 8-point font! If the clinical development time of a new treatment is to ever decrease, reducing the time in study activation is necessary so actual research can be done.

How Research Informs the COVID-19 Response

Research doesn’t just inform medical treatment; it informs public health and public policy, and it helps explain human behaviors.

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Part 11/Annex 11 Independent Audit and Compliance Assessment

Independent verification of compliance opens new doors for CRIO, Inc. and provides customers confidence that they can incorporate the eSource system into their own computer software validation strategy.

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UW Carbone Cancer Center Gains Visibility into Site Accrual with Insights

Discover how Advarra Insights helped UW Carbone Cancer Center reduce manual reporting and gain actionable visibility into accrual metrics and operations.

Most Popular Blogs of 2019

As we near the end of 2019, let’s take a look back at the blogs that generated the most interest this year from readers like you.

UW Carbone Cancer Center Improves CCSG Data Management Processes with EVAL

Learn how UW Carbone Cancer Center leveraged Advarra EVAL to improve CCSG processes, saving resources while earning an “Outstanding” renewal grade.

Indiana University Melvin and Bren Simon Cancer Center Sees 52% Time Savings with Advarra Participant Payments

Learn how IU’s Simon Cancer Center cut staff time by 52%, reduced inefficiencies, and optimized workflows with Advarra Participant Payments.

Advarra Acquires Forte:
What You Need to Know

On September 5, 2019, Advarra announced its intent to acquire Forte. The combined organization leverages mutual strengths in supporting the research community with client service, regulatory expertise, and technology-enabled efficiencies to accelerate innovation, streamline research operations, support faster study start-up, and help make research altogether better. Click here to read the full press release.

EVAL Case Study with Case Comprehensive Cancer Center

Discover how the Case Comprehensive Cancer Center used Advarra EVAL to streamline CCSG workflows, improve data analysis, and show research ROI.

Quorum/Kinetiq Acquisition & Integration:
What You Need to Know

On March 5, 2019, Advarra announced its acquisition of Quorum Review IRB and Kinetiq, the research and technology consulting division of Quorum. We’ve assembled this FAQ to address some of the most commonly asked questions about the acquisition and integration.