July 2022
More than 18,000 cases of monkeypox from 78 countries have been reported to the World Health Organisation, with more than 70% of cases identified in Europe and 25% in the Americas. The virus has also claimed its first lives outside Africa - one in Brazil and two in Spain:
The lack of diversity in clinical trials unfairly skews American medicine and costs billions of dollars a year in early deaths and poor health. The scope of the problem was laid out in a new report Improving Representation in Clinical Trials and Research. Building Research Equity for Women and Underrepresented Groups from the National Academies of Sciences, Engineering, and Medicine (free here):
In 2018 and 2019, multiple Alzheimer's and dementia trials ended earlier than planned. A multidisciplinary workgroup convened by the Alzheimer’s Association® in the USA has released 17 recommendations for clinical trial sponsors, researchers and staff about how to better communicate with study participants when trials stop sooner than expected:
Oxford Cannabinoid Technologies has announced clinical trial dates for its two products. Compound OCT461210, for neuropathic and visceral pain, will enter phase 1 trials in Q1 2023, and OCT 130401, an inhaled treatment for trigeminal neuralgia, will enter the clinic in Q3 this year. CRO Simbec Research will carry out phase 1 testing:
In a Viewpoint paper published in Communications Medicine, people who have been involved in clinical trials in a variety of roles discuss how clinical trial participants can be involved in clinical trials and how their involvement can maximise trial success and improve the patient experience:
Biotech Axcella Therapeutics is in discussions with the UK Medicines and Healthcare products Regulatory Agency (MHRA) to run a registrational trial of AXA1125 in the UK and USA in patients experiencing moderate-to-serious fatigue with long Covid-19. Regulatory conversations with the US Food and Drug Administration (FDA) will begin in the “near term”:
The US Food and Drug Administration (FDA) is inching closer to allowing human clinical trials for inter-species organ transplants, known as xenotransplants, specifically pig-to-human:
Amazon is developing cancer vaccines in collaboration with the Fred Hutchinson Cancer Research Center, and it recently launched an FDA-approved phase 1 clinical trial (of 20 participants over the age of 18) evaluating “personalised vaccines” for melanoma and breast cancer:
A lack of comprehension and monitoring of the ClinicalTrials.gov may be hindering access to trial information, holding up drug study results, and undermining rules designed to promote transparency. But neither the agencies nor staff overseeing the database routinely monitor individual trial records for veracity, and many studies could be in violation of US reporting regulations:
COVID-19 has put the UK in the grip of psychological crisis with the numbers suffering from distress twice as high as they were before the pandemic, according to the latest findings of The Covid-19 Rapid Survey of Adherence to Interventions and Responses (CORSAIR) study, led by University College London and King’s College London:
