The article discusses the high failure rate of clinical trials in oncology, attributing it to the inadequate reproducibility of preclinical cancer research. C. Glenn Begley and Lee M. Ellis highlight that many landmark findings in preclinical oncology are not reproducible due to issues with cell lines, animal models, and clinical trial design. They propose several recommendations to improve the reliability of preclinical cancer studies, including:
1. **More Opportunities to Present Negative Data**: Negative preclinical data should be presented at conferences and in publications, and all findings should be reported regardless of outcome.
2. **Blinding and Rigorous Validation**: Preclinical investigators should be blinded to control and treatment arms, use rigorously validated reagents, and include appropriate positive and negative controls.
3. **Diverse Cell Lines and Models**: Studies should use a variety of well-characterized cancer cell lines representative of the intended patient population.
4. **Biomarker Identification**: Patient-selection biomarkers should be identified at the outset of drug development.
5. **Accountability**: Investigators, laboratories, and institutions are responsible for the design, analysis, and presentation of data, and must maintain high standards of quality, ethics, and rigor.
The authors emphasize that improving the reproducibility and translational success of preclinical cancer research is crucial for advancing patient care and reducing the high failure rate of clinical trials.The article discusses the high failure rate of clinical trials in oncology, attributing it to the inadequate reproducibility of preclinical cancer research. C. Glenn Begley and Lee M. Ellis highlight that many landmark findings in preclinical oncology are not reproducible due to issues with cell lines, animal models, and clinical trial design. They propose several recommendations to improve the reliability of preclinical cancer studies, including:
1. **More Opportunities to Present Negative Data**: Negative preclinical data should be presented at conferences and in publications, and all findings should be reported regardless of outcome.
2. **Blinding and Rigorous Validation**: Preclinical investigators should be blinded to control and treatment arms, use rigorously validated reagents, and include appropriate positive and negative controls.
3. **Diverse Cell Lines and Models**: Studies should use a variety of well-characterized cancer cell lines representative of the intended patient population.
4. **Biomarker Identification**: Patient-selection biomarkers should be identified at the outset of drug development.
5. **Accountability**: Investigators, laboratories, and institutions are responsible for the design, analysis, and presentation of data, and must maintain high standards of quality, ethics, and rigor.
The authors emphasize that improving the reproducibility and translational success of preclinical cancer research is crucial for advancing patient care and reducing the high failure rate of clinical trials.