Clinical Holds Increasing for Cell and Gene Therapies

A recent analysis from EvaluatePharma found that clinical holds involving gene therapies doubled in 2019, with eight holds this past calendar year, compared to only four in 2018 and one in 2017. 

The holds in 2019 affected companies such as Sarepta, Advaxis, Adverum, Prevail Therapeutics, Aboena Therapeutics, Regenxbio and Novartis, as well as repeat offender Solid Biosciences, which experienced three gene therapy holds, one each in 2017, 2018 and 2019.

The EvaluatePharma report covered clinical holds in the past three years: in 2019 there were 19 clinical holds total across all therapeutic areas, 11 full and eight partial, imposed by the FDA for reasons varying from toxicity to manufacturing to administrative and even undisclosed reasons. 

For clinical holds by year, 2018 saw four less than 2019 overall, but 2017 was not far behind 2019 with 18 holds total.

StudyKIK Launches Mobile Study App to Improve Recruitment and Retain Trial Participants

StudyKIK has announced the development of a new mobile app to help trial participants have instant access to tools that may improve engagement and adherence, including a study progress meter, Uber & Lyft transportation integrations, medication reminders, 24/7 live phone support, patient payment tracker and an e-diary.

The app is compatible with both iOS and Android devices, and all data are encrypted to ensure data security.

NIAID Injects Millions into Antibacterial Resistance Research

The National Institute of Allergy and Infectious Diseases (NIAID) will inject $102.5 million into research funding over seven years for the Antibacterial Resistance Leadership Group (ARLG) to study countermeasures against antibiotic-resistant bacteria.

The funds from NIAID, which is part of the National Institutes of Health, will go to Duke University’s Clinical Research Institute. The effort will fund research with the University of California, San Francisco, in a diverse array of innovative, non-antibiotic approaches from vaccines, bacteriophages, viruses that selectively kill bacteria and other approaches that alter individual microbiomes to fight infections. 

The ARLG, formed in 2013, is a consortium of 50 scientific experts who lead a clinical research network that has completed more than 40 studies involving 20,000 participants. Recently, ARLG formed a partnership with the European COMBACTE consortium, a global network to support large studies with dozens of clinical trial sites.

Vaccine Research Gets $203 Million Boost from NIH

A new clinical trial consortium will lead research on infectious diseases with a $203 million grant from the National Institute of Allergy and Infectious Diseases (NIAID).

NIAID will grant $29 million per year for seven years to establish the Infectious Diseases Clinical Research Consortium, which will support the work of the institute’s Vaccine and Treatment Evaluation Units (VTEU).

The consortium, consisting of scientific experts and VTEU investigators, will prioritize candidate vaccines, diagnostics, therapeutics and other interventions to test in clinical trials. In cases of public health emergencies, the consortium will be able to rapidly initiate trials at the nine VTEU sites.

The VTEUs, located at academic and hospital research centers across the U.S., conduct phase 1 through phase 4 trials.

Approved Draft Law in Egypt Provides Provisions for Country’s Clinical Trials

The Egyptian cabinet approved for the first time a draft law in late December that dictates the standards required to design and conduct clinical trials in Egypt. 

Being the second-largest location in Africa for clinical research, Egypt has experienced a substantial increase in the number of new clinical trials in recent years. Approximately 1,000 trials are now active in the country. Prior to the draft law, trials were governed by ministerial decrees.

Egypt’s legislation requires trials to conform to international standards, including informed consent, as well as relevant national regulations.

Taproot, Cancer Centers Partner on Precision Oncology Trial

Taproot Health has joined forces with five cancer centers and community clinics across the U.S. to conduct a master observational trial to collect and share regulatory-grade, real-world consented patient data to help advance precision oncology. 

The observational trial, titled Master Registry of Oncology Outcomes Associated to Testing and Treatment (ROOT), will aggregate genetic and molecular data associated with different cancer therapies. 

Ultimately, data from the ROOT trial will be incorporated into a national oncology database, to be used for developing new personalized cancer tests and therapies.