Whitepapers

Dr. Peter Wahl, MLA, MS, ScD, VP and Global Head of Scientific Affairs at CorEvitas, part of the PPD™ clinical research business of Thermo Fisher Scientific, discusses the critical role of protocol-driven registries in generating regulatory grade RWE to serve multiple and evolving evidence needs across the drug development life cycle. He covers key considerations for selecting the right type of registry, explains why registry data is the gold standard in RWD, and how it contextualizes safety and effectiveness to fulfill FDA and EMA post-marketing requirements.

Market Data Analytics Buyer's Guide - Are you considering a medical claims data solution for healthcare business planning and strategy? Here’s how to make sense of the options.

A pharmaceutical company aimed to launch a Phase III clinical trial for a new oncology drug, focusing on efficient and effective patient recruitment across diverse regions. They evaluated patient populations by analyzing demographics, social determinants of health, and geography. Investigator profiling included practice details, affiliations, referral networks, and clinical trial experience. The final step involved selecting and extracting target lists for implementation.

This white paper presents findings from the PurpleLab Migraine Study, which leverages real-world data to analyze migraine prevalence, treatment variations, and provider insights. The study examines data from approximately 10 million Americans diagnosed with migraines, focusing on patient demographics, treatment pathways, and healthcare provider specialties. Key findings include the high prevalence of migraines among females aged 18-54, racial and ethnic disparities in treatment, and the significant role of specialized providers like psychiatrists and neurologists in managing migraine care. It highlights the importance of tailored treatment approaches and the potential benefits of complementary and alternative medicine therapies.

Clinical trials are crucial for drug development but often face delays due to poor site selection, which can lead to protocol violations, poor data quality, and increased costs. Ninety percent of clinical trials fail to meet their timelines, and issues like inadequate staffing and patient recruitment are significant challenges. Traditional site selection methods are inefficient, and the COVID-19 pandemic has further complicated the process. Data-driven insights can optimize site selection by evaluating current data on patient populations, investigators, and site capabilities.

Modern clinical trials can be an overwhelming experience for participants, compromising everything from medication adherence and data quality to overall study outcomes. AiCure’s H.Code is a patient engagement platform that reinvents the clinical trial experience for participants using cutting-edge AI, easy communication, and dedicated support for sites. Read our fact sheet to learn how H.Code extends the reach of your clinical team using an AI-powered analytics platform and a user-friendly smartphone app.

Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient engagement. Incorporating a patient engagement platform into your clinical trial enhances the patient experience and can lead to more successful trials with stronger, more reliable outcomes. We put together this helpful checklist of key features to look out for when choosing a platform for your study.

Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.

AliveCor knows that cardiac safety is critical, with concerns often driving drug withdrawals from trials and the market. Our solutions go beyond compliance to boost regulatory trust, data integrity, and trial success. As the only company offering integrated 6L and 12L ECGs, we provide comprehensive monitoring—onsite and remotely—to meet complex cardiac requirements. Our innovative tools empower sponsors and CROs to control trial data, enabling faster, smarter decisions throughout the research lifecycle.

A top 5 sponsor turned to WCG to recruit expecting mothers for its Phase III RSV vaccine trial. WCG support covered multiple countries and contributed almost one third of overall randomizations in the supported countries, bringing the study in ahead of schedule despite delays due to COVID-19 impacts on RSV seasonality. The sponsor met study timeline past enrollment by continuing to work with WCG’s retention support.

Find out if you’re working with the right IRB.

A sponsor needed to get their Phase II dermatology study enrollment back on track. The study was underway for 11 months across 32 sites globally with only 20 subjects enrolled to date. With WCG support, enrollment was concluded 24 months ahead of schedule.

A top 5 sponsor was falling behind on data entry for their global oncology portfolio, which included 130+ sites and 100+ protocols. WCG supported data entry and query resolution for 130+ sites, resolving data entry backlog in time for interim analyses.

A sponsor’s glaucoma and ocular hypertension studies were behind on enrollment. The sponsor had started an outreach campaign which was not providing the desired results. WCG developed a new recruitment strategy mid-study comprised of a multi-channel outreach campaign.

Get the initial IRB submission right the first time.

Recruitment and retention may appear to be simplistic in their primary functions. However, for these two processes to be successful, they must be applied in a way that resonates with the individuals that are stepping up to participate, whether that be out of a desire to impact the health of others or to provide treatment options for their own health condition. By adding people to the equation, we are adding variables of infinite complexity. Thus, an absence of process or lack of experience in one area can significantly affect others, leading to a cascade of problems that undermine recruitment and retention plans.

As the clinical trial recruitment landscape continues to evolve, patient recruitment remains a critical challenge. More innovative screening strategies can improve recruitment and enhance the quality of clinical research.

Increased interest in cell and gene therapies has led to a greater demand for expertise to help sponsors, CROs, and sites coordinate human gene transfer (HGT) research. Compared to clinical trials with older, more traditional classes of drug products, there are important similarities and differences in requirements for safe and ethical conduct of clinical trials of gene therapy and related modalities.

Are you tired of clinical trial technology that slows down processes? Are your sites looking for more intuitive solutions? At YPrime, we’ve taken a deep dive into site experiences and perspectives, sharing ways to bridge the gap between sponsors, sites, and patients, to foster a more efficient clinical trial process.

The current oncology and hematology drug development pipeline features a wide array of large molecule therapeutics. As a result, clinical trial protocols have grown more complex, requiring sponsors, CROs, and research sites to tackle a variety of challenges that were less common with older, more traditional therapies.