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Enhancing clinical studies with AI

50% of clinical trials fail due to inadequate designs or implementation errors, learn how AI solves these challenges.

Problem

Clinical trials are the cornerstone of medical research, but their design and execution are often riddled with methodological errors that can compromise the validity of results.

Common issues include errors in randomization, inadequate sample size selection, and flaws in statistical analyses [1].

These errors not only increase the cost and duration of trials but also lead to incorrect conclusions that impact the safety and efficacy of treatments.

Why it matters

  • It is estimated that up to 50% of clinical trials fail due to inadequate designs or implementation errors [2].
  • Furthermore, trials can take 6 to 7 years to complete, with costs exceeding $2.6 billion for each approved drug [3].
  • These factors create a significant opportunity cost by delaying patient access to innovative treatments and wasting valuable resources.

Solution

An AI assistant specifically designed for formulating clinical trial protocols can:

- Automate and optimize the randomization process.
- Calculate optimal sample sizes based on specific study criteria.
- Identify and correct methodological inconsistencies.
- Provide simulations and predictive analyses to evaluate potential scenarios before trial implementation [4].

Discover more and interact with our AI!

Datasources

The TrialMaster prompt was built using insights from papers on clinical trial design, including work from the Institute of Medicine (USA) and contributions from M. Shi et al. [7], who explore the role of AI in refining clinical trial protocols.

Citations

  1. Frutos Pérez-Surio, A., García Luján, R., & Martín Delgado, M. C. (2018). Common Methodological Errors in Clinical Research. Medicina Intensiva, 42(2), 128-136. https://medintensiva.org/es-errores-metodologicos-frecuentes-investigacion-clinica-articulo-S0210569118300123
  2. Brun, S., Bordes, J., & Davies, P. (2020). Challenges in Clinical Trials: Methodological Insights. Journal of Clinical Trials, 12(3), 85-95. https://pmc.ncbi.nlm.nih.gov/articles/PMC6985535/
  3. Macula-Retina. (2023). Starting Clinical Trials: Numerous Challenges Involved. https://www.macula-retina.es/iniciar-ensayos-clinicos-conlleva-numerosos-desafios/
  4. Dedalus. (2023). Artificial Intelligence for Farmabiotec. https://dedalus.com/spain/wp-content/uploads/sites/27/2023/10/articulo-dedalus-farmabiotec-septiembre-2023.pdf
  5. EuroEspes. (2023). Using Artificial Intelligence to Accelerate Clinical Trials. https://euroespes.com/boletin-medico/brevialia/uso-de-la-inteligencia-artificial-para-acelerar-los-ensayos-clinico
  6. EAFIT. (2023). Artificial Intelligence for Scientific Doctoral Research. https://eafit.edu.co/academia/profesores/Documents/Inteligencia-Artificial-para-la-investigacion-cientifica-doctoral.pdf
  7. M. Shi et al., "The role of artificial intelligence in improving clinical trial protocol design: a systematic review," npj Digital Medicine, vol. 3, no. 1, Aug. 2020, Art. no. 96. DOI: 10.1038/s41746-020-00306-4.

Problem

Clinical trials are the cornerstone of medical research, but their design and execution are often riddled with methodological errors that can compromise the validity of results.

Common issues include errors in randomization, inadequate sample size selection, and flaws in statistical analyses [1].

These errors not only increase the cost and duration of trials but also lead to incorrect conclusions that impact the safety and efficacy of treatments.

Problem Size

  • It is estimated that up to 50% of clinical trials fail due to inadequate designs or implementation errors [2].
  • Furthermore, trials can take 6 to 7 years to complete, with costs exceeding $2.6 billion for each approved drug [3].
  • These factors create a significant opportunity cost by delaying patient access to innovative treatments and wasting valuable resources.

Solution

An AI assistant specifically designed for formulating clinical trial protocols can:

- Automate and optimize the randomization process.
- Calculate optimal sample sizes based on specific study criteria.
- Identify and correct methodological inconsistencies.
- Provide simulations and predictive analyses to evaluate potential scenarios before trial implementation [4].

Opportunity Cost

A trial that fails due to methodological errors can result in a loss of $500 million in direct and indirect costs.

A one-year delay in drug approval could lead to an estimated $1 billion loss in revenue, considering lost market time and increased competition [5].

Resources wasted on failed trials could have been redirected to over 10 early-stage research projects or potential innovations [6].


Impact

  •  Reduce costs associated with methodological errors by 30-40%.
  • Accelerate the start and completion time of clinical trials by 20-30%.
  • Enhance the quality of results by ensuring more robust designs and reliable methodologies [6].


Data Sources

The TrialMaster prompt was built using insights from papers on clinical trial design, including work from the Institute of Medicine (USA) and contributions from M. Shi et al. [7], who explore the role of AI in refining clinical trial protocols.


References

  1. Frutos Pérez-Surio, A., García Luján, R., & Martín Delgado, M. C. (2018). Common Methodological Errors in Clinical Research. Medicina Intensiva, 42(2), 128-136. https://medintensiva.org/es-errores-metodologicos-frecuentes-investigacion-clinica-articulo-S0210569118300123
  2. Brun, S., Bordes, J., & Davies, P. (2020). Challenges in Clinical Trials: Methodological Insights. Journal of Clinical Trials, 12(3), 85-95. https://pmc.ncbi.nlm.nih.gov/articles/PMC6985535/
  3. Macula-Retina. (2023). Starting Clinical Trials: Numerous Challenges Involved. https://www.macula-retina.es/iniciar-ensayos-clinicos-conlleva-numerosos-desafios/
  4. Dedalus. (2023). Artificial Intelligence for Farmabiotec. https://dedalus.com/spain/wp-content/uploads/sites/27/2023/10/articulo-dedalus-farmabiotec-septiembre-2023.pdf
  5. EuroEspes. (2023). Using Artificial Intelligence to Accelerate Clinical Trials. https://euroespes.com/boletin-medico/brevialia/uso-de-la-inteligencia-artificial-para-acelerar-los-ensayos-clinico
  6. EAFIT. (2023). Artificial Intelligence for Scientific Doctoral Research. https://eafit.edu.co/academia/profesores/Documents/Inteligencia-Artificial-para-la-investigacion-cientifica-doctoral.pdf
  7. M. Shi et al., "The role of artificial intelligence in improving clinical trial protocol design: a systematic review," npj Digital Medicine, vol. 3, no. 1, Aug. 2020, Art. no. 96. DOI: 10.1038/s41746-020-00306-4.

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