Coronavirus Leading to Delays in U.S. Trials, Biotechs Set Up Secondary Domestic Supply Chains in Response

Efforts to contain the coronavirus outbreak in China have led to minor disruptions in drug testing timelines for Chinese contract research organizations (CROs), causing worry among many American biotech executives and investors who have backed trials in the virus-stricken country.

Travel restrictions represent one barrier to newly started and ongoing trials in China, especially in Wuhan — the epicenter of the outbreak — and several other cities. Additionally, some trial participants fear becoming infected with the coronavirus, named Covid-19, if they return to a healthcare facility for the trial.

Ongoing studies impacted by the current virus-containing restrictions in China include a Novartis medicine study for a rare blood disorder and a BeiGene cancer drug.

The country conducts about 20 percent of global clinical trials, up from 10 percent just five years ago, and the city of Wuhan is home to 500 trials listed in CT.gov.

FDA Biologics Center to Finalize Complex and Innovative Trial Guidance in 2020

Innovative trial designs and human gene therapies are on the list of 21 trial guidances the FDA’s Center for Biological Evaluation and Research (CBER) plans to release this year.

Sometime this year, CBER will finalize its September 2019 draft guidance advising sponsors to carefully consider the statistical approaches they will use in innovative and complex trial designs and discuss them with the FDA, especially Bayesian analysis (CenterWatch Weekly, Sept. 30, 2019).

According to the center’s agenda released on Friday, two new human gene therapy guidances focusing on neurodegenerative diseases and genome editing will join the suite of related guidances issued in January.

The agenda does not indicate release dates for the guidances.

Read the guidance agenda here: https://bit.ly/31VGlGW.

Nearly 600 Pediatric Drugs Being Tested in Trials, According to PhRMA Report

Nearly 600 pediatric drugs across various therapeutic areas are currently being tested in clinical trials, according to a report from the Pharmaceutical Research and Manufacturers of America (PhRMA).

In its report, PhRMA found that more than 2,100 industry-sponsored clinical trials are currently enrolling more than 1.2 million pediatric patients across a variety of therapeutic areas, including rare or hard-to-treat diseases.

According to the report, current pediatric trials include: 125 treatments for genetic diseases, 86 treatments for cancer, 75 medicines for infectious diseases and 55 medicines for skin disorders.

Read the full PhRMA report here: https://onphr.ma/38vk2KG.

Survey Finds Nearly Half of Doctors Do Not Talk to Patients with Cancer About Clinical Trials

Nearly half of doctors or medical teams do not discuss clinical trials with patients with cancer, with some medical teams actively discouraging trial participation, according to the first-ever Patient Power Cancer Clinical Trials survey.

A total of 666 patients with cancer responded to the survey between December 2019 and January 2020. Half of the respondents said they were “very likely” to participate in a cancer clinical trial, while 44 percent of respondents said they did participate in a trial. Approximately 85 percent of patients who said they were involved in a trial said they believe they gained a clinical benefit, and 65 percent said it was not financially burdensome.

Additionally, 57 percent of respondents who said they “were likely” or “possibly likely” to participate in a clinical trial said their medical team discussed trial participation during their care. The respondents said that their medical teams would discourage trial participation if they had stable disease, were responding to current therapy or had pre-existing medical conditions.

To read the results of the survey, click here: https://bit.ly/39yaHlA.

Oncology Dominates Clinical Trials in 2020, Says GlobalData

Oncology is set to dominate clinical trials in 2020, according to projections from analytics firm GlobalData. Following this lead will be trials for treating central nervous system disorders, infectious diseases, cardiovascular disease and metabolic disorders.

Approximately 62 percent of studies in the 2020 planned clinical trial landscape will be sponsored by industry, with oncology representing the highest rate of planned industry-sponsored trials. Eli Lilly and Novartis have currently reported the most planned trials in 2020.

The proportions of industry-sponsored trials for this year include 20.5 percent for oncology, 9.2 percent for trials of the central nervous system, 5.6 percent for infectious disease, 4.7 percent for metabolic disorders and 3.8 percent for immunology. Industry will also mostly sponsor trials for gastrointestinal, respiratory, dermatology and musculoskeletal disorders in 2020.

The U.S. dominates the number of trials to be launched in 2020, accounting for almost the same number of trials as the rest of the top 10 combined. China holds second place followed by Australia, France, Canada and the UK, according to GlobalData.

To read the full report, click here: https://bit.ly/3bFKzac.

University of Oxford Researchers Call for Reduced Reliance on Real-World Evidence

Researchers from the University of Oxford are arguing against the use of observational real-world evidence (RWE) studies as an alternative solution to randomized controlled trials (RCTs) in a paper published in the New England Journal of Medicine (NEJM).

In their paper, the authors suggest that large observational studies of RWE possess inherent biases that can ultimately lead to misleading associations between treatments and health outcomes. Observational studies may show effects of treatment that are null, when the therapy actually does exert clinically beneficial effects on disease outcomes, they say.

To reduce the reliance on RWE, the paper calls for guidelines that can assist in removing obstacles associated with RCTs to improve their quality and efficiency. Those guidelines include strategies such as increasing real-time monitoring of electronic data from local sites, implementing interactive electronic case-report forms to ensure complete data collection, and using mobile devices and sensors.

To read the NEJM article, click here: https://bit.ly/2HransI.

UK Begins Work on New Clinical Trial Legislation

Debate on a bill to develop new clinical trial regulations following the UK’s January separation from the EU is scheduled to begin March 2 in Parliament.

The bill, introduced late last week, would create regulations on clinical trials similar to the EU’s Medicines for Human Use rules.

Changes to clinical trial regulations could include amending the market authorization application process, making adverse event and safety reporting requirements more proportionate to low-risk trials, amending requirements for starting a trial, and updating and adding to good clinical practice standards.

Read the bill here: https://bit.ly/2SOevZ6.