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Multi-center Feasibility Clinical Study of the "Expert Consensus on Temporary Procurement of Novel Antineoplastic Drugs Based on Rapid Drug Evaluation"

Multi-center Feasibility Clinical Study of the "Expert Consensus on Temporary Procurement of Novel Antineoplastic Drugs Based on Rapid Drug Evaluation"

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091608
Enrollment
Unknown
Registered
2024-10-31
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncology

Interventions

Rapid health technology assessment system of antineoplastic drugs (utilize the rapid health technology assessment system of antineoplastic drugs established by the study group in the temporary procure

Sponsors

Shanghai Sixth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to 99 Years

Inclusion criteria

Inclusion criteria: Since the study is designed to be a nationwide multi-center study, the preliminary plan is to include at least 1 each of tertiary general hospitals, oncology specialty hospitals, and combined traditional Chinese and Western medicine hospitals in each province and city, and at least 4 participating evaluators in each hospital, with the following specific criteria: 1. Inclusion criteria of medical institutions: ? able to administer novel anti-neoplastic drugs; ? tertiary hospital; ? general hospital, specialized oncology hospital, or combined Chinese and Western medicine hospital. 2. Inclusion criteria of evaluators: doctors, pharmacists, or medical administrative staff working in medical institutions that meet the above inclusion criteria.

Exclusion criteria

Exclusion criteria: Does not qualify for the inclusion criteria or unable to provide the consent form

Design outcomes

Primary

MeasureTime frame
approval rate of temporary procurement application with rapid HTA score =60 ;change rate of temporary procurement application final decision before and after using the rapid HTA system;accuracy of the rapid HTA system;negative predictive value, NPV;

Secondary

MeasureTime frame
absolute difference of rapid HTA score among different sub-analysis groups;precision(positive predicative value, PPV) of the rapid HTA system;sensitivity of the rapic HTA system;F-measure;

Countries

China

Contacts

Public ContactCheng Guo

Shanghai Sixth People’s Hospital

gboss@126.com+86 189 3017 7555

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026