CRED Understanding Clinical Development 2024

14/10/2024

REFERENCES

• ICH Topic E 1 Population Exposure: The Extent of Population Exposure to Assess Clinical Safety https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-1-population-exposure-extent-population-exposure-assess-clinical-safety step-5_en.pdf

• ICH E8 General Consideration of Clinical Trials: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-8-general-considerations-clinical-trials-step 5_en.pdf

• ICH E9 Statistical Principles for Clinical Trials: https://www.ema.europa.eu/en/ich-e9-statistical-principles-clinical-trials

• ICH E 10: Choice of Control Groups: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-10-choice-control-group-clinical-trials-step-5_en.pdf

• Guideline on the evaluation of anticancer medicinal products in man (EMA/CHMP/205/95)

• CHMP Guideline on CV Disease Prevention : https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-medicinal-products cardiovascular-disease-prevention_en.pdf

• Guideline on clinical investigation of medicinal products, including depot preparations, in the treatment of schizophrenia (EMA/CHMP/40072/2010 Rev 1.)

• Lièvre A, et al., "KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer". Cancer Res. 66 (8): 3992 – 5

• Scientific Advice leads to stronger applications from Industry, EMA Website: https://www.ema.europa.eu/en/news/scientific-advice-leads-stronger-applications industry

• Cochrane Risk of Bias Tool https://handbook-5-1.cochrane.org/chapter_8/table_8_4_a_a_common_classification_scheme_for_bias.htm

• Mintzes, B. and Vitry, A., 2019. Flawed evidence underpins approval of new cancer drugs. BMJ , p.l5399.

• Schumi, J., Wittes, J.T. Through the looking glass: understanding non-inferiority. Trials 12, 106 (2011). https://doi.org/10.1186/1745-6215-12-106

• Sacca L. The uncontrolled clinical trial: scientific, ethical, and practical reasons for being. Intern Emerg Med. 2010 Jun;5(3):201-4. doi: 10.1007/s11739-010 0355-z. Epub 2010 Feb 19

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REFERENCES

• Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. CHMP/EWP/2459/02

• FDA Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics https://www.fda.gov/media/120721/download

• Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. CHMP/EWP/2459/02

• FDA Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics https://www.fda.gov/media/120721/download

• Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials. https://www.hma.eu/fileadmin/dateien/Human_Medicines/01 About_HMA/Working_Groups/CTFG/2019_02_CTFG_Recommendation_paper_on_Complex_Clinical_Trials.pdf

• Regulatory Decision ‐ Making in the United States Based on a Single Pivotal Clinical Study: Principles and Precedents https://www.tandfonline.com/doi/abs/10.1081/CRP-200041317

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