| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Charlton, Bruce G |
| Abstract | The fundamental methodological deficiency of megatrials is deliberate reduction of experimental control in order to maximize recruitment and compliance of subjects. Hence, typical megatrials recruit pathologically and prognostically heterogeneous subjects, and protocols typically fail to exclude significant confounders. Therefore, most megatrials do not test a scientific hypothesis, nor are they informative about individual patients. The proper function of a megatrial is precise measurement of effect size for a therapeutic intervention. Valid megatrials can be designed only when simplification can be achieved without significantly affecting experimental control. Megatrials should be conducted only at the end of a long process of therapeutic development, and must always be designed and interpreted in the context of relevant scientific and clinical information. |
| Related Links | https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/cvm-2-1-002.pdf |
| Ending Page | 6 |
| Page Count | 6 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 17456215 |
| DOI | 10.1186/cvm-2-1-002 |
| Journal | Trials |
| Issue Number | 1 |
| Volume Number | 2 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2001-01-30 |
| Access Restriction | Open |
| Subject Keyword | Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences epidemiology history megatrial methodology randomized trial Medicine/Public Health |
| Content Type | Text |
| Subject | Medicine Pharmacology (medical) |
| Journal Impact Factor | 2/2023 |
| 5-Year Journal Impact Factor | 2.1/2023 |
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