Several clinical trials are currently actively recruiting to investigate conditions including breast cancer, cervical cancer, atrial fibrillation, job stress, and autoimmune neurological disorders such as neuromyelitis optica spectrum disorder. Sponsored by academic institutions and health organizations including Johns Hopkins University, Northwestern University, and Brigham and Women's Hospital, these studies feature unassigned phase designations or are classified as not applicable. Overall, the research focuses on behavioral interventions, diagnostic evaluations, and biomarker analyses across these specified health conditions.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06026280 | Recruiting | Job Stress|Distress Emotional |
Inspiration at Work|Northwestern University |
2023-08-07 | Not Applicable |
| NCT05364138 | Recruiting | Breast Cancer|Benign Breast Disease|Cervix Cancer |
Brigham and Women''s Hospital|Partners in Health|Rwanda Biomedical Centre|Johns Hopkins University |
2023-07-31 | -- |
| NCT05862038 | Recruiting | Atrial Fibrillation |
Ana Jordan|University Hospital Dubrava |
2023-02-10 | -- |
| NCT05414890 | Recruiting | NMO Spectrum Disorder|NMDA-R Encephalitis|Diagnostic Self Evaluation|Immune System Diseases|Nervous System Diseases|Autoimmune Diseases of the Nervous System|Autoimmune Diseases |
Beijing Tiantan Hospital|Tianjin Medical University General Hospital |
2022-06-30 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).