The US Food and Drug Administration (FDA) has issued new draft guidance on the implementation of decentralised clinical trials (DCTs), in which some or all trial-related activities occur at locations other than traditional investigation sites. This could include carrying out clinical tests at a local facility rather than a research medical centre, or conducting follow-up visits in the participants’ homes using telemedicine. The 16-page document provides recommendations for sponsors, investigators and other stakeholders on the use of these trials, which the agency expects’ will play an important role in addressing public health needs’. ‘By reducing barriers to participation, we expect that DCTs will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges,’ the FDA said in a statement. The guidance covers recommendations on topics such as DCT design, the use of digital health technologies for remote patient monitoring, ...
Immunotherapy with blinatumomab leads to a strongly improved survival rate—from 66% to 93%—for children with an aggressive form of acute lymphoblastic leukemia (ALL). They also had fewer side effects from the treatment. Based on the results, blinatumomab will now become standard treatment worldwide for babies with this aggressive form of leukemia. Three quarters of babies with acute lymphoblastic leukemia (ALL)—three babies a year in the Netherlands—have a particular fault in the DNA of their leukemia cells. This so-called KMT2A rearrangement leads to an aggressive form of ALL with a poor prognosis. Despite intensifying chemotherapy, the prognosis for these babies has not improved in recent decades. Intensive chemotherapy works very well for half of the babies. But in the other half of the children, the disease returned within two years, or children died from the disease or sometimes from the side effects of the therapy. 90% of recurrences—when the cancer comes ...
The state of clinical trials in the NHS is “much worse than it has been in years” with patients losing access to cutting-edge cancer and dementia treatments, one of the UK’s most senior clinicians has warned. Sir John Bell, the regius professor of medicine at the University of Oxford and a government life sciences adviser, said the UK’s approach needed “a full overhaul, top to bottom” to prevent a collapse in the number of clinical trials being conducted in the NHS. “I don’t think there’s any doubt that companies are choosing not to evaluate their drugs in the UK,” he said. “The risks [to patients] are much bigger than have been alluded to.” The intervention comes after the government launched an independent review led by the former health minister James O’Shaughnessy into why the NHS had seen a 44% drop in participants recruited to commercial clinical trials in the past five years. The UK is rapidly ...
The changes will aim to make it easier to gain approval and to run clinical trials in the UK The Medicines and Healthcare products Regulatory Agency (MHRA) has said it will be introducing a series of measures aimed at streamlining clinical trials approvals in the UK. The changes, which represent the biggest overhaul in UK clinical trials regulation in over 20 years, include a legislative requirement to publicly register clinical trials and share summary results with research participants, as well as guidance to help researchers recruit a diverse cohort of participants. A timeline for completion of an application review within a maximum of 30 days will also be implemented by the MHRA, with a maximum of ten days for a decision to be granted once the regulator has received any final information. Marc Bailey, MHRA chief science and innovation officer, said: “Our world-first COVID-19 approvals showed how ...
San Francisco based Verge Genomics, the Neuroscience based drug discovery company launched in 2015, has raised $32 million in early venture capital financing to bring its AI-generated compounds against Parkinson’s disease and amyotrophic lateral sclerosis (ALS) to clinics within the next three years.
Acceleron Pharma and its partner Celgene have revealed that luspatercept hit its primary and secondary endpoints in phase 3 clinical trial of patients affected with chronic anemia associated with a rare blood disease.
NBTXR3 is composed of crystalline nanoparticles to amplify the efficacy of radiation therapy. The idea is to administer NBTXR3 as intra-tumoral injections before external beam radiation therapy, thereby increasing the antitumor effect, and thus preparing the patient for surgical resection.
A clinical trial solution has been unveiled by DNAnexus that facilitates the integration of genomics data sourced from next-generation sequencing (NGS) into clinical studies. A cloud-based genomic data collection platform is offered by DNAnexus.
NHS England has unveiled new processes designed to fast track clinical trials undertaken across the NHS, and boost access for patients.
Unified cloud-based eClinical platforms, with built-in scalability and modularity, will drive growth opportunities across the globe
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