The Institute for Clinical and Economic Review (ICER) is partnering with Aetion to develop decision-grade real-world evidence (RWE) that it will use to pilot a formal process for using RWE in 24-month reevaluations of drugs approved by the FDA under accelerated approval pathways.
The reevaluation will begin at the 24-month anniversary of any ICER final report on a drug’s approval and will span a period of several months, depending on the nature of the evidence to be generated.
At the end of 2019, there were 647 ongoing trials using regenerative medicines to treat rare diseases, according to a new report from the Alliance for Regenerative Medicine.
Of the total, 252 are phase 1 trials; 353 are phase 2 trials, and 42 are phase 3 trials, the report said. These trials focus primarily on gene-modified therapies, cell-based IO therapies, cell therapy and tissue engineering.
Read the full report here: https://bit.ly/3897hEX.
The FDA unveiled a pilot program last week that will use plain language and podcasts to explain its guidance documents in snapshots posted to its website.
The guidance snapshots will only accompany guidances on clinical trials and drug development. New ones will be posted when the guidances are released by the agency, but for the few first rounds the FDA plans to release snapshots on some previously published guidances.
Each snapshot will include a brief summary of the guidance, including why it is important and the most critical points. In addition, the authors of each guidance will present its highlights in a podcast, which will also be available in a transcript.
The snapshots will also feature a timeline for when to apply the agency’s recommendations. The agency will include Twitter hashtags aimed at encouraging discussion on the guidance and a link to the FDA docket for providing comments for applicable draft guidances.
Access the snapshots here: https://bit.ly/2T7DZC2.
IQVIA has launched Avacare Clinical Research Network, a global site network covering 19 different therapeutic areas in the U.S. and India.
The technology-based network, formerly known as Qcare, uses artificial intelligence (AI) to refer patients to trials. Avacare’s clinical technology solution produces data-driven enrollment patterns and possesses proprietary algorithms using health records.
A survey from BBK Worldwide shows that healthcare consumers and clinical trial participants are aligned on how they use tools to manage their health, negating the myth that these two groups think differently about healthcare-related technology, doctor access and quality of care.
The survey also found that healthcare consumers and clinical trial participants are both as likely to use wearables consistently (19% and 16%, respectively). Additionally, both groups reported a preference for having multiple ways they can communicate with their physicians.
Email communication with physicians was ranked as very important for 51% of clinical trial participants and 44% for healthcare consumers, whereas phone communication was ranked as very important for 66% of trial participants and 57% of healthcare consumers.
To read more about the report, click here: https://bit.ly/2PwQBk2.
Apple and Johnson & Johnson last week launched a virtual clinical trial to examine how the Apple Watch performs in identifying and predicting atrial fibrillation in approximately 150,000 people.
The study will randomize participants aged 65 years and older into two groups: one that will use a Heartline Study smartphone app and another that will use the app plus an Apple Watch. No drugs will be given in the trial. Research data firm Evidation Health is also participating in the trial.
During the trial, users will receive education on heart health and wellness. Each week the app will ask participants to complete surveys to collect self-reported data.
Clinical research company Clinerion will now use Wefight’s Vik app, in combination with Clinerion’s Patient Network Explorer platform, to help it find and match patients to clinical trials.
Wefight’s Vik app helps patients learn more about their disease, but under the new partnership, the app will now have access to Clinerion’s patient data from its network of hospitals.
Gilead last week announced it would begin two phase 3 studies of its investigational antiviral remdesivir, a treatment for COVID-19, in March, largely in Asian and other countries “globally with high numbers of diagnosed cases,” the drugmaker said.
Also last week, NIH announced a U.S. phase 2 trial for the Gilead antiviral being conducted at the University of Nebraska Medical Center in Omaha.
Remdesivir is also being studied in two phase 3 trials in China’s Hubei province — the epicenter of the coronavirus outbreak — with results expected next month, Gilead said. An expert panel in China has also fast-tracked clinical trials of five new drugs for COVID-19.
On the vaccine front, Moderna Therapeutics, which has teamed up with the NIH for help in funding development and manufacturing efforts, said that it had shipped the first batch of a proposed vaccine for a planned phase 1 trial in the U.S.
A vaccine for the coronavirus will likely be ready for a phase 1 clinical trial in two months — a month sooner than initially projected — according to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.