Community engagement is a critical step in improving the diversity of clinical trial participants, but this demands more than simply setting up a site in an area with an underserved population. Sustainable growth in recruitment and retention requires ongoing engagement beyond efforts to recruit for a specific trial. Seneca Harrison: “Street teams” support community outreach  Quality Clinical Research (QCR) has taken a unique approach to community engagement, setting up a “street team” at each of the company’s five U.S. locations. Two more locations will open in the first half of 2024, wit ..read more

Are you hoping to make the most out of attending your first ACRP conference in Anaheim in early May but feeling a little anxious about the “sit down next to someone you don’t know and introduce yourself” ritual of such big gatherings? Take heart—if you drum up some courage and listen to the wisdom of those who have gone before you, you will find yourself looking back on your time at ACRP 2024 with the pride of accomplishment that comes from putting your best foot forward, getting in the game, and making great professional strides in your clinical research career.  Network, Network, Networ ..read more

Clinical research trainers will tell you that not every trainee will flourish under the same kind of instruction—some excel in face-to-face classroom settings, some blossom with online courses, and guided reading or some combination of these with other learning methods will hit the spot in other cases. However, when it comes to learning how to effectively conduct the sensitive and mandatory process of informed consent with clinical trial volunteers, simulated consenting holds many advantages for trainees who are new to the concept—and even for seasoned site staff whose consenting practices cou ..read more

This is a sponsored message. Clinical researchers today need strong grant-writing skills to get their high-impact research projects approved and funded. Yet effective writing techniques typically aren’t taught in medical school, leaving many researchers struggling to create opportunities to further their work. That’s why the Harvard Medical School Postgraduate Medical Education’s Global Clinical Scholars Research Training program fills in the gaps to strengthen participants’ skills in this area and equip them with a valuable competitive edge to move the field forward.  Preparing Clinical ..read more

Many in the clinical trials ecosystem would like to see wider adoption of decentralized clinical trial (DCT) elements. “Yet, despite recent draft guidance from the U.S. Food and Drug Administration,¹ as an industry we haven’t made huge strides in adopting this model for interventional studies,” notes Noelle Gaskill, Head of Clinical Research Collaborations at Mirati Therapeutics, Inc. “Sponsors still lack reassurance that all regulatory requirements will be met, and technology adoption is a true barrier for sites. In addition, there has been a lack of practical, real-life experiences to learn ..read more

This is a sponsored message. Clinical research lacks workers — but through the functional service provider (FSP) model, we’re training the professionals we need. Clinical research is in the midst of a serious talent shortage — a challenge the industry can expect to face for the next several years. Some experts predict the global labor crunch will last at least into 2030, when most baby boomers will have left the market, but younger workers won’t yet be prepared to step into vacated roles. During the shortage, the clinical research community has continued to champion innovation and acceleration ..read more

The process of assessing clinical trial feasibility is in urgent need of improvement. Aimed at predicting whether a trial at a particular site will succeed, feasibility involves determining whether the site has the necessary patients, staff, technology, and other resources. In turn, site staff must decide whether the site should accept the study based on available resources.{1} The challenges of feasibility assessment are underscored by the fact that around 70% of trials have start-up delays, 80% fail to achieve on-time enrollment, and 45% miss completion targets.{2} With surging trial volumes ..read more

Advances in diversity, equity, and inclusion (DEI) demand more than simply offering people from underrepresented populations a seat at the table. “While this is a good starting point, we must also take a close look at what happens at that table,” says Ashley Moultrie, CCRP, Director of DEI and Community Engagement at Javara. “Success depends on what happens next.” Moultrie explains that “people from marginalized populations must be fully welcome and treated equitably, sharing the same experience as earlier participants in all these discussions. This includes having updates on earlier conversat ..read more

This is a sponsored message. Global Disruptions, Health Equity, and Data Sharing International clinical trials are essential to evaluating the safety and efficacy of new treatments, but their success can be hampered by a variety of challenges. A recent McKinsey analysis of drugs and vaccines developed since 2000 shows that it takes nearly 10 years to go from clinical testing to approval. Additionally, how do you ensure that the vaccine distribution is equitable? When time is of the essence, how do you scale trials internationally for success? First, let’s look at some challenges and then oppor ..read more

This is a sponsored message. Clinical research operations are becoming increasingly digital. Attended a conference, tuned in to a webinar, or talked to your peers within the industry lately? It’s apparent that clinical trial sites are increasingly investing in technology to digitize and streamline their workflows. Despite this, many sites continue to rely on traditional paper-based methods or in-house digital documentation systems. These systems often lock sites into inflexible workflows that hinder their ability to integrate, participate, and connect with sponsors and contract research organi ..read more