uMotif and Cogstate collaboration will include work on psychedelic trial

2023-11-10

临床研究

The collaboration brings research sponsors and contract research organizations (CROs) the combined power of uMotif’s cloud-based, patient-centric eCOA/ePRO platform and cognitive testing services for digital assessments and rater training and monitoring.

The companies say they will be deepening commercial and operational integrations and will be supporting CROs and sponsors in capturing ‘high-quality clinical and cognitive data’ with a particular focus on central nervous system (CNS) indications including within the fast-growing area of psychedelics research.

uMotif CEO Steve Rosenberg said: “We’re delighted to be working with Cogstate. They have a well-earned reputation for combining advanced cognitive science and digital innovation to simplify the complex measurement of cognition in research and patient care. Together, we’ll significantly improve patient engagement and data quality in all therapeutic areas, and especially CNS research.”

Neurological or psychedlic disorders

In their research, the companies found that an estimated 2 billion people worldwide suffer from a neurological or psychiatric disorder, with substantial unmet medical needs. In the area of psychedelic therapies alone, federal governments and private ventures are investing millions to learn how these treatments might help address debilitating mental illnesses, a market sector projected to reach $5.7 billion by the end of 2027.

As part of uMotif’s integrated eCOA solutions, the cloud-based system also supports a wide range of clinician-reported outcomes (ClinROs), including those requiring audio recording of assessments for central review and scoring.

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"We have been impressed with the patient-centered approach at uMotif to impact the speed, quality, and accuracy of data,” said Cogstate CEO Brad O’Connor. “We are excited to jointly deliver modern technologies and solutions that improve cognitive data insights in the trials we support.”

FDA guidance on psychedlic drugs

On June 26, this year (2023), the US Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance).

The guidance gives sponsors who are developing psychedelic drugs for the treatment of medical conditions including psychiatric and substance use disorders, several points to consider.

Clinical trials that will be conducted under an investigational new drug application (IND) specifically.

The psychedelics allowed to be used are limited to psilocybin, lysergic acid diethylamide (LSD), and methylenedioxymethamphetamine (MDMA).

The guidance shows the FDA recognizes that psychedelic drugs have therapeutic potential. The FDA also shows willingness to work with researchers on the development of the drugs. It also recognizes that there are several challenges associated with drug development and clinical studies working with such substances.

Unable to provide specific recommendations about study design because of the unique and emerging area of drug development, the guidance presents foundational constructs, organized by discipline, that all sponsors studying the therapeutic potential of psychedelic drugs should consider.

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