4/27/2023 0 Comments Novamind serial number![]() ![]() Novamind has experience with psychedelic-assisted therapies through its ketamine treatments, but Robison says their expertise extends further. Taking these factors into consideration is important for any CRO handling a psychedelic study and the approach it takes could give it a competitive edge against other companies in the field. Shifting Strategy, MAPS Turns to Equity Investment “It’s a nuance that’s important in the psychedelic space because of the trip the patient goes on,” says Sabrin. How does a clinical trial account for the experience the group receiving the treatment undergoes compared to the group receiving the placebo? How does the location, ambiance and conversation impact the treatment? Including the Psychedelic Experience in Clinical DataĪnother important question in designing and executing clinical trials with psychedelic therapies is how the psychedelic experience is incorporated into the trial, says Sabrin. Sabrin agrees that a CRO with expertise in developing ways to deliver psychedelic therapies could position itself to alleviate that bottleneck. There are more patients interested in psychedelic therapies than there are trained clinicians to deliver therapies and that has resulted in a natural bottleneck, says Sam Sabrin, senior advisor to Tabula Rasa and JLS, which invests in companies developing psychedelic-assisted therapies. The IRB independently evaluates and monitors the research to make sure it’s ethically acceptable and that the study participants are protected. We collect and enter all data for these subjects in order for Merck to evaluate the data in real time to determine outcome of trial and medication.”Įvery clinical research study at Cedar Clinical Research goes through an institutional review board (IRB) approval process, says Robison. “As a selected site, we are responsible for recruiting, screening, and enrolling subjects per the protocol guidelines that were outlined and defined by Merck. “We did not have any part in designing that phase of the study, though this is one of our capabilities,” says Robison. According to Robison, Novamind is currently recruiting and enrolling patients for the Merck study. “It really turns out to be a win-win,” says Robison.Ĭurrently, Novamind is partnering with pharmaceutical company Merck on a phase II study of the drug MK-1942 for treatment-resistant depression. Patients in the Novamind network may have access to upcoming trials and studies that might be relevant to their treatment. This could also help ease some of the challenges of locating patients for studies supported by companies contracting with Novamind CRO services, says Robison. As clinic patients are already interested in psychedelic therapies, they provide a pool of possible study subjects that can be recruited for studies of psychedelic medicines. The Cedar Clinical Research study sites are co-located with the Cedar Psychiatry clinics, and their relationship is symbiotic, says Conforti. Novamind also expects to expand to another state by the end of the year, says Conforti. The new service, dubbed the Murray Clinic, also doubles as Novamind’s third clinical research site. In September of 2021, Novamind announced it had opened a sixth integrative psychiatry clinic in Murray, Utah. Novamind is now planning to scale Cedar’s existing network of clinical and research sites, says Conforti. “We’re really participating in this mental health revolution that’s long overdue.” Scaling Clinical and Research Sites “Because of our research background of working with this medicine, we adopted it as soon as it came to market,” says Robison, who is cofounder and medical director of Cedar Psychiatry. To date, Cedar Psychiatry has delivered more than 7,000 ketamine treatments and more than 4,800 Spravato treatments, says Conforti. Cedar Psychiatry began offering clients Spravato as soon as it was available and is now one of the leading providers of the treatment. Cedar Clinical Research was part of the Janssen Pharmaceuticals study that supported the development of Johnson & Johnson’s Spravato, an esketamine nasal spray for treatment-resistant depression.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |