Where Can Patients Obtain Information on the Preapproval Access Pathway to Investigational Treatment in Japan? A Survey of Patient Advocacy Organizations' Websites.
Clin Pharmacol Drug Dev
; 8(8): 978-983, 2019 11.
Article
in En
| MEDLINE
| ID: mdl-31592580
ABSTRACT
Investigational treatments are those that have been approved for testing in humans but are not yet available as an approved treatment option. For many patients with a terminal illness who have no approved treatment option and are not eligible for a clinical trial, investigational treatments are the last resort. However, not much is known about the dissemination of information by patient advocacy organizations (PAOs). We evaluated the quantity and quality of information on preapproval access to investigational therapies provided by Japanese PAO websites between January 24 and March 29, 2019. A total of 49 PAOs were identified. Of these, 16 (33%) provided no relevant information. The most frequent information provided was the PAO's own clinical trial finder or list of clinical trials (n = 15, 31%); of the 10 cancer-related PAOs, 5 (50%) provided this information. Nine (18%) PAOs had developed patient registries or provided a link to relevant registries. Only 1 PAO (2%) provided a link about the Ministry of Health, Labour, and Welfare trials that described the process and regulations of clinical trials. Our results indicate that PAOs do not disseminate adequate information on preapproval pathways. We suggest that the government involve PAOs in disseminating this information to both patients and physicians.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Patient Advocacy
/
Internet
/
Access to Information
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Therapies, Investigational
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Information Dissemination
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Health Information Systems
Limits:
Humans
Country/Region as subject:
Asia
Language:
En
Journal:
Clin Pharmacol Drug Dev
Year:
2019
Document type:
Article
Affiliation country: