Blogs

Despite the rush for an effective COVID-19 therapy, biotech industry leaders insist rigorous research and complete data will be the standard preceding approvals.

Beyond technology, awareness, and access—cultural competence is key.

EMA has launched a "communication perception survey" looking for honest views from among the widest audience on how well it is doing.

Rasmus Hogreffe, former Head of Virtual Trials at LEO Innovation Lab, and current VP of Decentralized Trial Innovation at Medable, and Morten Kirkegaard, Head of Clinical Operations and Co-founder at REDO-neurosystems, discuss their experiences with decentralized trials.

As biopharma companies and research institutes advance the development of promising vaccines against COVID-19, policy makers and health officials have intensified deliberations on strategies for ensuring fair and equitable distribution of anticipated preventives.

The search for a coronavirus vaccine is just one of many questions unanswered on European health policy.

A look at the evolution of clinical trial recruitment, challenges the industry still faces, and how it can use automation to enhance enrollment efforts.

JoAnne Schaberick, Co-CEO of Pro-ficiency, discusses how their simulation training platform is helping provide remote clinical trial site training to sponsors and study sites.

Now officially a worldwide pandemic, the biomedical research community is rushing to develop treatments and preventives to halt the spread and severity of the COVID-19 virus.

Jing Zhao, Chief Business Officer of Refuge Biotechnologies, discusses how dead cas9 can be leveraged to completely control gene expression without making permanent edits as seen with CRISPR technology.

Tzvia Bader, CEO of TrialJectory, discusses how the company’s AI-powered technology platform is democratizing cancer care and expanding access to advanced new treatments.

With the Coronavirus causing significant disruptions in the clinical trials industry, Sponsors should expect data quality issues due to missed visits and a reduction in enrollment rates.

Though on its way out of the European Union, the UK is trying to align its trial approval practice with the EU’s new clinical trial regulation.

Ravi Jandhyala, Consultant Pharmaceutical Physician at Medialis and an expert in rare disease patient registries, discusses how to overcome clinical trial registry challenges.

Allyson Gage, Chief Medical Officer at Cohen Veterans Bioscience talks about her perspectives on platform trial design.

Teenagers with cancer could benefit from a proposed initiative to lower the age barrier for participation in trials for new oncology drugs.

With the coronavirus now spread across northern Italy, the EU is assembling its forces to slow the virus with an aid package worth $250 million.

Sponsors conducting trials in China are facing delays, while efforts to test potential antivirals and vaccines against COVID-19 are having enrollment difficulties.

Teenagers with cancer could benefit from a recommendation to lower the age barrier so they can take part in clinical trials says a proposal from the Fostering Age Inclusive Research Trials Initiative.

While “Big Data” is a great buzzword in management circles, small data (with big problems) never gets much attention.

Analysis of over 330,000 Phesi trial protocols shows predicting future enrollment performance by extrapolating data is flawed.

Greenphire's Chief Commercial Officer predicts 2020 will continue the momentum towards greater technology adoption and patient focus.

The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.

FDA’s new commissioner, Stephen Hahn, announced his priorities at an FDA “all hands” staff meeting last week. Jill Wechsler reports.

Involving patients more meaningfully in the industry's activities means getting more serious about their emotional wellbeing.

Social media uses transparency to highlight alleged gaps in clinical trial transparency and offers a more powerful approach to health campaigners.

With the biopharma industry making strides in gene therapies by focusing on patients with specific genetic traits, Karmen Trzupek, Director of Clinical Trial Services at InformedDNA, discusses how to address the presented challenges of this approach.

The EMA is going to take a rather bolder approach to the use of data than in Germany, judging from major statements just out at the end of January.

John Rigg, senior principal, Predictive Analytics, Real World Solutions at IQVIA, discusses how patient disease modeling and diagnostic prediction is made possible with artificial intelligence and machine learning.

Non-reporting has attained a high profile in Europe, partly because of the EMA's attempts to tackle the problem, and partly because of a highly-visible “name-and-shame” social media campaign.