Clinical Research Focus. 3rd Edition

Healthcare Leaders to Collaborate on Digital Measurement for Alzheimer’s Disease

Some of the world’s leading pharmaceutical companies, including Biogen, Eisai, Eli Lilly, and Merck, are joining forces to establish digital standards for Alzheimer’s Disease clinical studies.

The collaboration will also involve researchers from Boston University and Oregon Health & Science University, as well as the Alzheimer’s Drug Discovery Foundation. The aim is to develop a core set of digital measurements that can be applied in clinical trials to more effectively track the efficacy of treatments for AD and related dementias. Read more here.

Clinical Trial of Three mRNA HIV Vaccines Launched in US

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, recently launched a Phase 1 clinical trial evaluating three experimental HIV vaccines based on a messenger RNA (mRNA) platform — a technology used in several approved COVID-19 vaccines. The study is among the first to examine mRNA technology for HIV. Read more here.




New Report Documents Success of EMA’s PRIME Scheme in Addressing Patients’ Unmet Needs

A new report on the EMA’s Priority Medicines (PRIME) scheme concludes it has had a positive impact on the authorization of new medicines that address patients’ unmet medical needs.

The scheme, which was started in 2016, aims to support the development of medicines that are expected to benefit patients with no current treatment options for their disease. It provides early and enhanced regulatory support and since 2016 a total of 18 treatments have been approved under the scheme. Ten of these have been treatments for rare diseases. Some of the medicines developed under PRIME include innovative technologies such as CAR T-cells therapies, one-time curative gene therapies, treatments for rare cancers, and a vaccine to protect against the Ebola virus. Read the report here.

FDA Issues Guidance on Use of Master Protocols to Expedite Cancer Clinical Research

The FDA recently issued a number of guidance documents to advance the development of cancer treatments.

They include guidance on increasing the participation of older people in oncology clinical trials and advice on designing and conducting trials with multiple expansion cohorts. The agency also issued guidance on the use of master protocols in oncology clinical studies. Master protocols can help advance clinical drug development as they allow more than one drug or treatment, more than one disease type, or more than one patient population, to be evaluated under a single clinical trial structure. Read more here.





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