Europe Puts Renewed Emphasis on Patient Communication
As pair of initiatives show, the clinical trials community in Europe is working harder to get its message across to its key partner: patients.
The clinical trials community in Europe is working ever harder to get its message across to its key partner: patients. The second workshop of the European Patients' Academy on Therapeutic Innovation (EUPATI), entitled "Reaching a Public Audience on Medicines Development," was held in Warsaw, Poland, earlier this month. In addition, the BBC has released a free video about the risks and ethical aspects of clinical trials.
The EUPATI workshop has been designed to draw on the group's social research work involving patients and citizens across Europe, as well as to hear views from patient advocates and the public and to provide details about successful examples of information sharing. EUPATI is funded by the Innovative Medicines Initiative (IMI), and aims to provide scientifically reliable, objective, and comprehensive information to patients on clinical research. The consortium's goal is to increase the capabilities of well-informed patients and patient organizations to be effective advocates in clinical research.
In a separate initiative, trial organizers have participated in a video that should help reassure patients after continued fallout from the 2006 clinical trial disaster involving six healthy volunteers at Northwick Park Hospital in London. In the incident, volunteers were treated for organ failure after experiencing a serious reaction within hours of taking the anti-inflammatory drug, TGN1412.
Such incidents are unlikely to happen again, according to experts quoted in a BBC article published last year. Things have changed, they said, since the release of the Duff Report, which was written in response to the Northwick Park trial. Among the changes is the U.K.'s Medicines and Health products Regulatory Agency (MHRA) now ensures that ethics committees look at preclinical data to decide whether the first dose given to humans is the right dose.
The BBC video begins with a news report about the Northwick Park disaster, before discussing the clinical trial process. To view the video, visit http://www.bbc.co.uk/learningzone/clips/clinical-trials-regulation-and-ethics/1465.html
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
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.
