Clinical trial design

Deepika Khedekar, Associate Centralized Clinical Lead at IQVIA, explains how artificial intelligence could make clinical trials more accurate, accessible and standardised. Over 19 million1 hearts succumb to cardiovascular disease yearly, while around 10 million2 lives are claimed by cancer every year. To put this scale into perspective, these numbers surpass the combined population of the […]

A new free service will offer insights in under ten days to sponsors conducting clinical trials, identifying potential ‘zombie trials’ and providing actionable recommendations for failing trials. The Health Check and Trial Rescue Service is an initiative of data software and services company Phesi. The service will use the company’s AI-driven Trial Accelerator Platform to […]

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%. According to the plans, initial applications for the lowest-risk Phase III and IV trials will be processed by the MHRA within 14 days instead of the statutory 30 […]

A new whitepaper has introduced the concept of ‘cross-over’ options in cancer clinical trials, as a way to make trials more patient-centric in design. ‘Cross-over arms in oncology clinical trials: An important consideration for patients’ was published by the Cholangiocarcinoma Foundation (CCF) with the aim of opening new doors for patients with limited treatment options. […]

Analysis of 13,490 clinical trials finds almost a third have been cancelled during Phase II amidst an overall decline in clinical development productivity. Data analytics company Phesi has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date. The analysis reveals that Covid-19 is no longer one of […]

Cancer Research UK has joined the PRIME-ROSE project, a Europe-wide effort to boost patient access to precision cancer medicine (PCM). The PRIME-ROSE consortium consists of 24 partners, including nine beneficiaries and fifteen associated partners who will come together over the course of five years and work with regulators, policymakers, healthcare providers and patient advocacy groups […]

The US Food and Drug Administration (FDA) has published new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for the potential treatment of medical conditions, including psychiatric or substance use disorders. This is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelic […]

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates.  There has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to […]

News round-up for 5-9 June by DDW Digital Content Editor Diana Spencer. There has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to modernise the design and conduct of studies, and the failure of Bellerophon Therapeutics’ Phase III study in fibrotic Interstitial Lung […]

The US Food and Drug Administration has published draft guidance with updated recommendations for good clinical practices (GCPs) to modernise the design and conduct of clinical trials. The updates are intended to help pave the way for more efficient clinical trials. The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated […]

Clinical trial technology platform Inato, based in Paris, France, has closed a $20 million Series A funding from investors including Cathay Innovation, Obvious Ventures, La Maison and Top Harvest Capital. With the new funding, Inato will advance its diversity product offering to meet the new FDA requirements. The company will also invest in oncology-specific innovation […]

A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. These changes represent the biggest overhaul in UK clinical trials regulation in over 20 years and are designed to make the […]

Craig Stevens, Senior Patient Engagement Specialist, and Amanda Henkel, VP, Strategy from MEDiSTRAVA (an Inizio Company), delve into the challenges and opportunities that surround clinical trial design for rare diseases. The drug development process requires collaboration at all stages, and is particularly important in the rare disease setting, where in addition to pharmaceutical industry stakeholders, […]

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates.  Perhaps most interestingly this week, after previous caution over in vivo gene therapy trials, the FDA has given the go ahead to Intellia Therapeutics […]

LEO Pharma and ICON have formed a strategic partnership that will enable LEO to offer clinical trials within medical dermatology that are patient-centric and cost effective. The partnership will operate under the acronym of PACE, reflecting the requirement to move quickly to address today’s clinical development challenges. It also represents the values of Passion, Agility, Communication and Excellence in delivery. […]

News round-up for 6-10 March by DDW Digital Content Editor Diana Spencer.  Perhaps most interestingly this week, after previous caution over in vivo gene therapy trials, the FDA has given the go ahead to Intellia Therapeutics to study NTLA-2002 in hereditary angioedema (HAE).  There have been several other announcements related to clinical trials in the last few days, […]