Funding for AI in Clinical Trials Decreasing, New Report Says

Reversing a two-year trend, total investment for using artificial intelligence (AI) in clinical research and drug development dropped 23 percent in 2019, according to a new research report.

Signify Research, a healthcare technology analysis firm, looked at funding of startups focused on creating AI tools for drug development and clinical trials. After a high of $1.7 million in 2018, investments dropped to $1.3 million in 2019. The report says 54 percent of funding went to information synthesis efforts, 32 percent went to drug design activities and 14 percent to clinical trial applications.

The decline in funding new AI solutions for clinical trials reflects investors’ and sponsors’ desire to see more evidence and proof-of-concept of the technology’s value in clinical trials, says the report.

To read the report, click here: https://bit.ly/2T9ebWA.

China Updates Requirements for Medical Device Clinical Trials

China’s National Medical Products Administration (NMPA) updated its clinical trial regulations for medical devices last month, designating eight device categories that require clinical trials. It also added new exemptions from clinical trial requirements, allowed conditional approval with limited clinical data and published guidelines on the use of real-world data (RWD).

The eight Class III device types include a variety of implantables, such as cardiac pacemakers, blood pumps and orthopedic implants. NMPA says it will accept data from trials outside China for these devices.

Exemptions for 40 class III devices, 108 class II devices, and 23 class III IVDs were added to the new clinical trial rules. There are now 1,002 medical devices and 401 IVDs that are exempted from trials in China. The new exemptions were included in the NMPA update to make clinical exemptions of devices more consistent with internationally accepted standards, says Leon Lei of consulting firm ChinaMed Device.

Additionally, the new changes from the NMPA state that conditional approval can be granted to devices indicated for life-threatening diseases, particularly if the benefits of the device outweigh potential or known risks. For conditional approval to be granted, the manufacturer of the device must commit to performing additional clinical trials on their product(s).

NMPA also described 11 situations in which RWD can be used to support clinical trials. They include the use of RWD as an external control for single-group experiments, to evaluate treatments of rare diseases and for postmarket surveillance.

For more information on these developments, register for the FDAnews webinar on the topic on Jan. 21: https://www.fdanews.com/chinanmpa.

UK Calls for Complex Innovative Design Trials to Study Cancer Therapies

Despite the potential of complex innovative design (CID) trials, there are no practical guidelines in Europe that focus on how to perform these trials, according to a UK cancer research organization.

The Experimental Cancer Medicine Centres (ECMC) working group lists 10 recommendations for creating innovative trials, including early regulator involvement in design, training and support for participants, anticipating future protocol modifications, flexible statistical methods and a trial management group to oversee the studies. The consensus statement also recommends timely dissemination of trial results, pathways for accelerated approval, analysis of trials’ impact on public health, staff training in complicated methodologies and using practical patient materials, such as a trial handbook.

The CID model the ECMC is pushing for mirrors that of the adaptive clinical trial design in the U.S., which the FDA recently issued guidance on (CenterWatch Weekly, Dec. 9, 2019).

To read the ECMC statement, click here: https://go.nature.com/2FxhPSg.

Finland Modernizes Clinical Trial Regulations

Clinical trials in Finland must report adverse events right away rather than in a quarterly report, according to revised regulations from the Finnish Medicines Agency — Fimea.

Prior regulations required a quarterly or semiannual report of adverse events. Under the revision, sponsors must report adverse events to Fimea no later than seven days of becoming aware of the events. Serious unexpected adverse reactions that are not life-threatening or fatal must be reported within 15 days.

The regulations, which took effect Jan. 1 now mirror what is required in the U.S.

Another change in the regulations is that trial materials now must be submitted electronically via the Common European Submission Portal and its associated secure mail service. In the past, they were submitted as signed hardcopy documents.

In addition, all trial results must be submitted to the EU register of clinical trials, EudraCT. Other changes to Fimea’s clinical trial regulations include an update on the definition of an interventional clinical trial and requirements concerning the labeling of investigational medicinal products.

To read the regulations, click here: https://bit.ly/2T8sF9q.

Amylgen and Neuron-Experts Partner to Evaluate Potential Alzheimer’s Drugs

Two CROs in France are joining forces to create a comprehensive offering of in-vivo and in-vitro efficacy evaluation for neurodegenerative disease compounds.

Amylgen will combine its portfolio of in vivo tests with Neuron-Experts’ in vitro assessments to give investigators a single source of tools to identify the most promising drug candidates.

The partnership initially will focus on treatments for Alzheimer’s disease but plans to expand its assessments to other neurodegenerative diseases.

Veristat Expands Reach in Europe by Acquiring The Clinical Trial Company

To improve its presence in the European market, Veristat has acquired The Clinical Trial Company (TCTC Group), a CRO headquartered in Knutsford, UK.

TCTC Group focuses on gene and cell therapy, orphan disease and central nervous system trials. This buy follows another European acquisition by Veristat made just four years ago, when it bought out UK-based Spero Oncology.