Course

UNIT 1. Drug discovery and development process:                                              15 hours.

• Introduction of drug discovery and development 4 hours
  • Need for drug discovery 1
  • Drug discovery (Target identification and validation, Lead finding, Lead optimization, Early safety tests) 1 hr.
  • Pathways of drug development (Discovery, Preclinical and clinical development)  2 hr.

·         Various Approaches to drug discovery    2 hours

1. Pharmacological:
   • Pharmacological profiling (In vitro profiling, in vivo profiling: Testing in animal models of disease) 1 hr.
   • Validity criteria in context to animal testing (Face validity, Construct validity, Predictive validity), Safety pharmacology 1 hr.

B)    Toxicological:                                                                                                 2 hour

• Preclinical toxicity testing: Acute toxicity (Acute tolerance testing) Sub chronic and chronic toxicity 1 hr.
• Tissue specific toxicity 1

C)    Investigational new drug Application (INDA):                                          3 hours

• Importance and types of INDA and Laws 1
• Regulations, Policies, (USFDA CFR) 1
• Procedures of submission of INDA and Different criteria for IND application  1 hr.

D)    Drug characterization and Dosage form:                                                   4 hours

• Drug characterization techniques in drug development process, 1
• Dosage form design in pre-clinical and clinical stages,
• Biopharmaceutical classification of drugs and Critical Pharmacokinetic parameter in drug development. 2 hr.

UNIT 2. Clinical development of drug:                                                                  31 hours

1. Introduction to Clinical trials 6 hours
   • History, Purpose and Importance of clinical trials 1hr

• Ethical guidelines in Clinical Research: Ethical Issues in Biomedical Research –

Principles of ethics in biomedical research                                                     2 hr.

• Historical Perspectives: Thalidomide study, Nazis Trials, Tuskegee Syphilis Study, The Belmont Report, Nuremberg trials 1h

–     The    declaration    of   Helsinki,    Origin    of   International    Conference          on Harmonization – Good Clinical Practice (ICH-GCP) guidelines.          2 hr.

B)    . Good Clinical Practice                                                                                2 hours

• ICH-GCP 1
• Central drug standard control organization (CDSCO) guidelines 1

C)    Challenges in the implementation of guidelines                                         4 hours

• Professional training on GCP, infrastructure, regulatory environment, and IRC/IEC  2 hr.

• ICD administration, safety reporting, investigational product, record keeping/source documents, grants/payments, trial report/publications. 2 hr.

D)    Institutional Review Board (IRB) / Independent Ethics Committee (IEC) 1 hr.

• Composition, responsibilities, procedures of IRB / 1 hr.

E)    . Various phases of clinical trial:                                                                  3 hours

• Interventional trials and Observational trials 2
• Health outcome measures (Clinical & Physiological, Humanistic, and economic) 1 hr.

F)       Methods of post marketing surveillance                                                    2 hours

• Sources of Post Marketing Surveillance 1
• Types of Post Marketing Surveillance

G)     Abbreviated New Drug Application submission.                                      1 hours

• Introduction and Requirement of ANDA 1

H)     Overview of regulatory environment in                                                    1 hours

• Regulatory environment in India, USA and Europe 1

I)      Role and responsibilities of clinical trial personnel as per ICH GCP    3 hours

• Sponsor and Investigators 1
• Contract research coordinators and Clinical research associate 1
• Auditors and Regulatory authority 1

J)     Designing of clinical study documents                                                        2 hours

• Protocol, and CRF 1
• ICF, PIC with assignment 1

K)     Informed consent Process                                                                           1 hour

• Process and Types of ICF 1

L)      Data management and its components:                                                     3 hours

• System Requirement for Data Management: Electronic data capture systems  1 hr.

• Clinical Trial Data Management: Standard Operating Procedures 1
• Quality Control and Quality Assurance in CDM 1

M)  . Safety monitoring in clinical trials.                                                           2 hours

• Data and Safety Monitoring Board (DSMB) 1
• Interim analysis and Final analysis 1

UNIT III: Application of Artificial Intelligence in Clinical Research                 4 hours

1. AI in Clinical Trial Design and Patient Recruitment 1

• Predictive analytics for protocol design
• Patient stratification and inclusion/exclusion optimization
• Real-world data (RWD) integration

B)    AI for Trial Monitoring, Data Management, and Outcome Prediction 1 hr.

• Risk-based monitoring and anomaly detection
• Natural language processing (NLP) for adverse event reporting
• AI in electronic data capture and remote monitoring

1. Ethical and Regulatory Considerations for AI in Clinical Trials 2

• Transparency and explainability of AI algorithms
• Regulatory perspectives (FDA, EMA) on AI use in clinical research
• Data privacy, informed consent, and bias mitigation in AI tools

This course is designed to make the students to understand the principles and gain adequate knowledge regarding the various approaches to drug discovery including clinical phase of development. Also enables the students to understand and implement all regulatory and ethical requirements that are required during the process of drug development. The students will build a deeper understanding of drug characterization, clinical trials, Good Clinical Practice (GCP) guidelines, and ethical considerations in clinical research. This involves grasping the concepts and interpreting them within a real-world context.

Applying their knowledge in clinical trial designs, regulatory processes like Investigational New Drug Applications (INDA), and submission of Abbreviated New Drug Applications (ANDA), which will prepare them for professional practice in the field of drug development. Through assignments on clinical study documents and data management systems, students will be tasked with creating detailed reports, ensuring they can generate new ideas or solutions that improve clinical research practices. Students will also gain practical insights into the roles and responsibilities of clinical trial personnel, preparing them for professional roles in clinical research, data management, and regulatory affairs, ensuring a well-rounded skill set in drug development.

Upon successful completion of the course, the student shall be able to:

KNOWLEDGE

K1: Describe the concept and process of new drug development.

K2: Discuss the various types of clinical trials and their designs.

K3: Illustrate the roles and responsibilities of key players in clinical trials.

K4: Apply the importance and application of regulatory and ethical requirements in clinical trials.

K5: Employ the data management aspects of clinical trials.

K6: Evaluate the detailed aspects and complexities of safety monitoring and reporting in clinical trials.

SKILL

 S1: Compare the knowledge to conceptualize, design, and conduct clinical trial activities.

S2: Develop the significance and implications of different clinical trial designs.

S3: Correlate the clinical trial data.

S4: Analyze AI-based approaches for improving patient recruitment and trial efficiency.

S5: Ensure a clinical trial protocol based on study objectives and regulatory requirements.

S6: Evaluate various tools and techniques for effective data interpretation in clinical trials.

ATTITUDE

A1: Distinguish commitment to ethical standards in clinical research.

A2: Collaborate effectively with diverse teams in the clinical research environment. A3: Explore emerging trends and advancements in clinical research.

A4: Attain a critical and analytical mindset towards clinical research data and processes. A5: Demonstrate the ethical principles in conducting Clinical research.

A6: Illustrate clear and effective communication in clinical research settings.

1. Guru Prasad Textbook on Clinical Research, a guide for aspiring professionals and professionals, 2^nd Edition, Pharma Med Press; 2018.
2. P.R. Chowadry. A textbook of clinical research and Pharmacovigilance, First Edition, PharmaMed Press; 2022.

REFERENCE BOOKS (THEORY)

1. Goodman Gilman A,Rall W, Nies, A.I.S. and Taylor, P. Goodman and Gilman’s The Pharmacological Basis of therapeutics. 13^th Ed, Mc Graw Hill: New York; 2017
2. Lawrence Friedman C.,FurbergD., David L., David M. Christopher B. G. Fundamentals of Clinical Trials 5th Edition, Springer; 2015.

GUIDELINES/ONLINE RESOURCES

1. gov: https://www.clinicaltrials.gov
2. European Union Clinical Trials Register (EU CTR): https://www.clinicaltrialsregister.eu
3. International Council for Harmonisation (ICH): https://www.ich.org/
4. Central Drugs Standard Control Organization: https://cdsco.gov.in/opencms/opencms/en/Home/