AI-Driven Drug Testing: Enhancing Precision and Human Relevance

AI-Driven Drug Testing: Enhancing Precision and Human Relevance

Sub: Sci

Sec: Health

Why in News

• The U.S. Food and Drug Administration (FDA) has proposed draft guidelines regarding the use of Artificial Intelligence (AI) in evaluating drug safety and effectiveness. This marks a significant step in integrating AI into pharmaceutical research, addressing the limitations of conventional animal-based drug testing methods.

Challenges in Conventional Drug Development:

• Traditional drug development, reliant on animal models, takes approximately 10 years and costs over $1 billion per drug.
• The success rate of drugs developed using animal models is only 14%.
• Animal metabolism differs significantly from humans. For example, rats eliminate some drugs faster than humans, skewing dosage and efficacy predictions.
• Population Diversity: Human drug responses vary based on age, sex, genetic factors, and pre-existing conditions, which homogeneous lab-bred animal models fail to predict accurately.

AI in Drug Development:

• AI scans vast compound databases to shortlist promising drug candidates.
• AI models simulate drug responses, reducing reliance on animal trials.
• AI enhances data analysis, ensuring accurate patient risk assessment.
• AI monitors real-world drug effects, identifying adverse reactions efficiently.
• AI models analyse human physiological data to predict drug absorption, distribution, and elimination patterns.
• AI-driven “safety toolboxes,” as demonstrated in a 2024 U.K. study, predict potential side effects on unintended organs, improving risk assessment.

Challenges in AI-Driven Drug Testing:

• AI models are only as effective as the data they are trained on. Poor-quality or biased data can compromise predictions.
• The “garbage in, garbage out” principle underscores the importance of diverse and representative datasets.
• Many AI models operate as “black boxes,” lacking transparency in decision-making processes.
• Limited access to training data makes independent validation of AI models challenging.
• AI models continuously evolve, making regulatory monitoring complex.
• Ethical concerns arise regarding the inclusion of vulnerable populations, such as children, in AI-driven studies.

Global Regulatory Initiatives:

• The European Medicines Agency (EMA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have issued similar guidelines.
• India’s New Drugs and Clinical Trials (Amendment) Rules, allow AI-generated data to supplement traditional safety assessments, reducing dependence on animal trials.

About International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH):

• Founded in 1990, ICH is a unique project that brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration.
• Formulates guidelines to harmonise technical requirements across member regions, covering areas like quality, safety, efficacy, and multidisciplinary topics.
• Encourages the adoption of these guidelines by regulatory authorities and industry to ensure consistent application.

About New Drugs and Clinical Trials (Amendment) Rules, 2024:

• India’s Ministry of Health and Family Welfare announced significant amendments to the New Drugs and Clinical Trials Rules, 2019, aiming to enhance the clinical trial framework in the country.
• Recent Amendment in 2024:
  • Definition of Clinical Research Organisation (CRO): Introduced a clear definition, encompassing sponsors or entities responsible for conducting clinical trials or bioavailability / bioequivalence studies.
  • CROs must register with the Central Licensing Authority (CLA) before initiating any clinical trials or related studies.
  • Submission of application in Form CT-07B along with a fee of INR 5,00,000 is required.
  • Grant and Validity of Registration: The CLA reviews applications within 45 working days, granting registration via Form CT-07C if criteria are met. Registration is valid for five years, with provisions for renewal.
  • Operational Conditions for CROs:
    • Maintain requisite facilities and qualified staff as per the Ninth Schedule.
    • Obtain protocol approval from an Ethics Committee and permission from the CLA before commencing studies.
    • Register all studies with the Clinical Trial Registry of India prior to enrolling participants.
    • Adhere to approved protocols, Good Clinical Practice guidelines, and relevant regulations.
    • Report any serious adverse events to the CLA within 14 days.
    • Provide appropriate medical management and compensation in cases of injury, disability, or death during a study.
    • Allow inspections by authorized officers and maintain study-related data for specified durations.