Study Startup Solutions Improve CRO Oversight Through Collaboration

Published: May 2020 by Oracle Health Sciences

This white paper defines CRO oversight, describes the importance of relationship building among stakeholders, and takes a look at innovative solutions for streamlining study startup a notorious bottleneck and a critical step toward managing study statuses in real-time. Learn More

Deploying Remote Site & Patient Support Staff in Response to COVID-19

Published: March 2020 by WIRB-Copernicus Group

Uncertainty over the future impact and implications of COVID-19 continues to exacerbate the preexisting issue of under-resourced sites.

Overwhelmed and lacking proper bandwidth, many sites may not have the appropriate infrastructure to adapt to this everchanging situation. Strategically placed remote site and patient support can ease that burden by carrying out a customized support plan tailored to the unique needs of each study site. Whether offering remote support in any type of trial or ensuring safe proper procedures on-site, WCG's remote site staff can work within any study team to ease the burdens that threaten to keep new therapies from reaching patients. Learn More

Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation

Published: February 2020 by The Avoca Group

So often, inspections are a major source of stress in the clinical trial environment. This is especially true when processes involved in preparing for an inspection are reactive. But, it doesn’t have to be that way. Using industry-leading practices and resources enables a proactive approach to mitigate — or even eliminate — the pain points associated with preparing for inspections. Learn More

Clinical Research Trends & Insights for 2020

Published: November 2019 by WIRB-Copernicus Group

In this report, 16 subject matter experts from WCG and our partners share the important shifts, trends, regulations, and priorities that will inform clinical trial development in 2020 and beyond. The insights and predictions are grouped into six topics: Scientific Advancements, Study Design, Study Conduct, Technology & Data, Public Policy & Regulatory Oversight, and Patient Advocacy.Learn More

Understanding the RTF Letter: Practical guidance on what the FDA is looking for, and how to avoid receiving one

Published: November 2019 by YourEncore

The business impact of the Refusal-To-File letter is always negative and frequently significant. However, there are many activities a company can undertake to reduce the likelihood of receiving an RTF letter. Learn More

Ethical Biosafety Oversight of Gene Transfer Research

Published: October 2019 by WIRB-Copernicus

The number of drug products under development that incorporate recombinant or synthetic DNA or RNA, viral vectors, and/or genetically-modified organisms (“GMOs”) continues to grow rapidly, and several such products have received marketing approval from the FDA. This paper focuses on important points to consider when planning to initiate clinical trials with these products at sites inside or outside the USA, if the research is subject to rules and regulations of the FDA and/or the National Institutes of Health (NIH) of the United States. In particular, we focus on the roles of Institutional Biosafety Committees (IBCs) and Institutional Review Boards (IRBs) in approving and facilitating study startup. Learn More

Advances in Oncology Extend Lives, but Lead to New Safety Considerations for Sponsors and Investigators

Published: October 2019 by WIRB-Copernicus

From cardiovascular adverse events to complex dosing regimens, oncology trials present unique safety-related considerations. Left unaddressed, they could undermine a trial or put patient safety at risk. In this paper, we discuss some of those issues and how sponsors can best address them. Learn More

The Most Important Voice Is Missing: The Case For Including Patient Insights In Protocol Design

Published: May 2019 by WIRB-Copernicus

Patient voice isn’t an accessory; it’s foundational. Patients are key to clinical trials, and relegating them to mere “subjects” diminishes their value. Including the patient voice in study design and development can make an enormous difference in recruitment, enrollment, and retention. Doing so also pleases regulators, who are increasingly putting a premium on patient-focused drug development. It doesn’t have to be difficult, but getting it wrong — or not doing it at all — can undermine a trial. Learn More

Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk

Published: May 2019 by WIRB-Copernicus

Safety reporting may be the most inefficient aspect of clinical trials today. It’s also among the most expensive, costing sponsors more than $700 million per year. Most are not receiving the best value for their investment, and some don’t even know how much they are spending. Automation has helped resolve some of the challenges, but it has created just as many. The system needs a complete overhaul. It can be done, but it requires the willing to invest in change. Learn More

Virtual Clinical Trials Best Practices

Published: January 2019 by WIRB-Copernicus

In recent years, along side the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials. In the virtual trial model, clinical studies are focused on bringing the clinical study directly to the participant and allowing data collection to be completed in a participant’s home or local community. This paper examines the nature of virtual clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance. Learn More

Invert to Convert: Rethinking Patient Recruitment and Enrollment Strategies

Published: January 2019 by WIRB-Copernicus

Despite all the advances in science, medicine and technology, clinical trials are stuck in a rut: Most have trouble meeting enrollment targets. It’s an analog problem in a digital world. The current approach-starting at the top of the recruitment funnel simply doesn’t make sense anymore. Perhaps it never did. Learn More

Compensating Participants in Clinical Research: Current Thinking

Published: October 2017 by WIRB-Copernicus

Sponsors, researchers and Institutional Review Boards (IRBs) are often wary about payments in research participation, citing concerns about coercion and undue influence, whether real or perceived, and have avoided payments that are “too high.” New research on how people make decisions about research participation, and new approaches to this question, bring a new perspective; are payments to participants actually too low? This paper explores this question, and whether we should, in fact, worry much less about restricting compensation for research participants. Learn More