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caso de aducanumab ¿Más esperanza que ciencia?
Eliana Sánchez-Montoya, Max Andresen, Raúl Corrales, Jorge Gallardo, Viviana Noriega, Caroline R. Weinstein-Oppenheimer. ARS MEDICA Revista de Ciencias Médicas, 2021-08-26
Topic: Drug trials: efficacy and safety
En junio, la Agencia de Alimentos y medicamentos de los Estados Unidos (FDA) otorgó aprobación mediante vía acelerada al medicamento aducanumab, desarrollado por Biogen, Inc. para tratamiento de la enfermedad de Alzheimer (EA). Esta autorización no ha estado exenta de controversia, ya que no se basó en un criterio de beneficio clínico demostrado, sino en un resultado de valoración sustituto, como es la reducción de la placa β-amieloide (Aβ). Primero con mecanismo novedoso aprobado para EA desde 2003 (Jaffe, 2021).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Sánchez-Montoya, E., Andresen, M., Corrales, R., Gallardo, J., Noriega, V., & Weinstein-Oppenheimer, C. R. (2021). caso de aducanumab ¿Más esperanza que ciencia? ARS MEDICA Revista de Ciencias Médicas. https://doi.org/10.11565/arsmed.v46i3.1826
Vancouver
Sánchez-Montoya E, Andresen M, Corrales R, Gallardo J, Noriega V, Weinstein-Oppenheimer CR. caso de aducanumab ¿Más esperanza que ciencia? ARS MEDICA Revista de Ciencias Médicas. 2021. doi:10.11565/arsmed.v46i3.1826.
BibTeX
@article{sanchezmontoya2021-27930c38,
author = {Sánchez-Montoya, Eliana and Andresen, Max and Corrales, Raúl and Gallardo, Jorge and Noriega, Viviana and Weinstein-Oppenheimer, Caroline R.},
title = {{caso de aducanumab ¿Más esperanza que ciencia?}},
journal = {ARS MEDICA Revista de Ciencias Médicas},
year = {2021},
doi = {10.11565/arsmed.v46i3.1826},
url = {https://doi.org/10.11565/arsmed.v46i3.1826}
}
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Key findings
- En junio, la Agencia de Alimentos y medicamentos de los Estados Unidos (FDA) otorgó aprobación mediante vía acelerada al medicamento aducanumab, desarrollado por Biogen, Inc. para tratamiento de la enfermedad de Alzheimer (EA).
- Esta autorización no ha estado exenta de controversia, ya que no se basó en un criterio de beneficio clínico demostrado, sino en un resultado de valoración sustituto, como es la reducción de la placa β-amieloide (Aβ).
- Primero con mecanismo novedoso aprobado para EA desde 2003 (Jaffe, 2021).
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Study details
- Evidence strengthLow
How this study scored 39/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomised / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record, multi-centre collaboration and free to read, so those were left out: it earned 22 of the 56 points we could judge it on, which is 39 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (ARS MEDICA Revista de Ciencias Médicas) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 22 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 22 of the 56 points we could judge it on is 39 out of 100. |
| Total | 39 / 100 | — |
What each of these 20 components measures, and what this score is not →
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