| Title |
Biomarker and Clinical Trial Design Support for Disease-Modifying Therapies: Report of a Survey of the EU/US: Alzheimer’s Disease Task Force
|
|---|---|
| Published in |
The Journal of Prevention of Alzheimer's Disease, March 2018
|
| DOI | 10.14283/jpad.2018.13 |
| Pubmed ID | |
| Authors |
Jeffrey Cummings, N. Fox, B. Vellas, P. Aisen, G. Shan, EU/US Alzheimer’ Disease Task Force |
| Abstract |
Disease-modifying therapies are urgently needed for the treatment of Alzheimer's disease (AD). The European Union/United States (EU/US) Task Force represents a broad range of stakeholders including biopharma industry personnel, academicians, and regulatory authorities. The EU/US Task Force represents a community of knowledgeable individuals who can inform views of evidence supporting disease modification and the development of disease-modifying therapies (DMTs). We queried their attitudes toward clinical trial design and biomarkers in support of DMTs. A survey of members of the EU/US Alzheimer's Disease Task Force was conducted. Ninety-three members (87%) responded. The details were analyzed to understand what clinical trial design and biomarker data support disease modification. Task Force members favored the parallel group design compared to delayed start or staggered withdrawal clinical trial designs to support disease modification. Amyloid biomarkers were regarded as providing mild support for disease modification while tau biomarkers were regarded as providing moderate support. Combinations of biomarkers, particularly combinations of tau and neurodegeneration, were regarded as providing moderate to marked support for disease modification and combinations of all three classes of biomarkers were regarded by a majority as providing marked support for disease modification. Task Force members considered that evidence derived from clinical trials and biomarkers supports clinical meaningfulness of an intervention, and when combined with a single clinical trial outcome, nearly all regarded the clinical trial design or biomarker evidence as supportive of disease modification. A minority considered biomarker evidence by itself as indicative of disease modification in prevention trials. Levels of evidence (A,B,C) were constructed based on these observations. The survey indicates the view of knowledgeable stakeholders regarding evidence derived from clinical trial design and biomarkers in support of disease modification. Results of this survey can assist in designing clinical trials of DMTs. |
Mendeley readers
The data shown below were compiled from readership statistics for 37 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 37 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Ph. D. Student | 5 | 14% |
| Other | 4 | 11% |
| Student > Master | 4 | 11% |
| Researcher | 4 | 11% |
| Professor | 3 | 8% |
| Other | 4 | 11% |
| Unknown | 13 | 35% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 5 | 14% |
| Neuroscience | 4 | 11% |
| Pharmacology, Toxicology and Pharmaceutical Science | 2 | 5% |
| Nursing and Health Professions | 2 | 5% |
| Agricultural and Biological Sciences | 2 | 5% |
| Other | 6 | 16% |
| Unknown | 16 | 43% |
Attention Score in Context
This research output has an Altmetric Attention Score of 7. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 06 April 2018.
All research outputs
#4,838,109
of 25,382,440 outputs
Outputs from The Journal of Prevention of Alzheimer's Disease
#397
of 595 outputs
Outputs of similar age
#90,359
of 351,776 outputs
Outputs of similar age from The Journal of Prevention of Alzheimer's Disease
#6
of 9 outputs
Altmetric has tracked 25,382,440 research outputs across all sources so far. Compared to these this one has done well and is in the 79th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 595 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 21.6. This one is in the 27th percentile – i.e., 27% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 351,776 tracked outputs that were published within six weeks on either side of this one in any source. This one has gotten more attention than average, scoring higher than 73% of its contemporaries.
We're also able to compare this research output to 9 others from the same source and published within six weeks on either side of this one. This one has scored higher than 3 of them.