Rethinking Clinical Trials

OCTOBER 4, 2022

Senior Director Clinical Trial Operations. Clinical Trial Transformation Initiative (CTTI); Decentralized Clinical Trials (DCTs); Digital endpoints; Developing novel endpoints. Decentralized trials require novel technology and digital endpoints. Marianne Chase. Neurological Clinical Research Institute. Jörg Goldhahn, MD.

Trials 130

Trials Clinical Trials Clinical Trials Production 130

XTalks

FEBRUARY 27, 2024

Skyclarys (omobaloxone) was approved in 2023 for the treatment of adults and pediatric patients 16 years of age and older with Friedreich’s ataxia, a rare, neurological disease​​. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial. The FDA introduced its Orphan Drug Act in 1983.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

XTalks

DECEMBER 21, 2022

This included greater adoption and acceptance of decentralized clinical trial models, emphasis on patient-centric approaches in trials, growing digitization of healthcare and dealing with drug manufacturing challenges. Gene Therapy Approvals. Manufacturer: Ferring Pharmaceuticals A/S. Manufacturer: bluebird bio, Inc.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

pharmaphorum

OCTOBER 4, 2022

During the first stage of the initiative, more than 2,000 research papers were published, 49 clinical trials were carried out, and more than 30 patents were filed through the support of the US National Cancer Institute (NCI). Building a bank.

Biobanking 104

Biobanking Clinical Trials Clinical Trials Trials 104

Rethinking Clinical Trials

OCTOBER 31, 2023

PaxLC brings together many innovations including online screening, digital medical record review, e-consent, home-delivery of medications, local clinical blood draws, home-based biospecimen collection, online diaries and surveys, digital medical record outcomes, and participant-centricity, and return of results.

Trials 228

Trials Medicine Research Clinical Trials 228