Applied Clinical Trials
Efforts are escalating to encourage sponsors, research institutions, and clinical investigators to accept oversight for multi-center studies by central institutional review boards (IRBs), as seen in several discussions of this topic at the December conference on "Advancing Ethical Research" sponsored by Public Responsibility in Medicine & Research.
The combined EuroMeeting and Clinical Forum, slated for mid-April, will take place in Paris as planned, in spite of January's terrorist attacks in the French capital, according to the Drug Information Association (DIA).
"We are working closely with the venue and the city of Paris to make sure all security measures are taken and on-site security will be reinforced," says Natacha Scholl, team leader of operations for DIA in Europe, Middle East & Africa. "We will put everything in place to reassure participants, of course."
Scholl does not anticipate that the attacks will have any great impact on delegate numbers. "Registrations haven't stopped over the past days, despite the tragic events," she says.
As of Jan. 15, there were already more than 650 registered participants, and Scholl said the organizers are expecting at least 2,500 to 3,000 attendees in total for the two events. The EuroMeeting and Clinical Forum have never before been held at the same location, but there were around 2,500 participants at the 2013 EuroMeeting in Amsterdam and around 2,200 at the 2014 EuroMeeting in Vienna. The Clinical Forum attracts an average of 400 attendees each year.
Globalization remains a key industry trend and one that will be discussed heavily at both events. The continued significance of global markets was listed as the 10th leading trend in pharmaceuticals, according to DIA's second annual "What Lies Ahead?" report.
"It is important for companies to work in global markets, especially in developing markets like China, pan-Asia, Russia and Eastern Europe, India, and Brazil, Argentina, Venezuela, and other Latin American countries, as this is where the majority of future growth will be," wrote the authors.
Successful companies, they said, conduct early stage analysis and planning to account for varying global factors when selecting countries for expansion, and they also create partnerships to address these needs and to build infrastructure, including training of the workforce.
According to the DIA report, "The topic of global markets is, as one thought leader expressed, 'almost an established fact of life and no longer a trend.'"
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.