Course

Unit 1

UNIT I Clinical Trials: Types and Design 8 hours ICH Harmonized Tripartite Guideline: General considerations for clinical trials (E8) (1 hr) Phases of clinical trials- 0, I, II, III, IV (1 hr)

Sources and control of bias, Blinding/Masking- Single, double, triple; Randomization- Simple randomization, restricted randomization, blocking method and stratification (2 hrs)

Types of clinical research designs based on: (3 hrs)

• Controlling Method (Experimental, Quasi experimental, and Observational methods)
• Time Sequences (Prospective and Retrospective)
• Sampling methods (Cohort study, case-control study and cross sectional study)
• Health outcome measures (Clinical & Physiological, Humanistic and economic)

Open label study, matched pair study, cross over trial, equivalence trials, superiority trials and non-inferiority trials (1 hr)

Unit 2

UNIT II International Regulatory Perspectives of Clinical Trials 8 hours

WMA Declaration of Helsinki- Ethical Principles for Medical Research Involving Human Subjects,

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use- Mission, Guidelines and Standards (1 hr)

ICH Harmonized Tripartite Guideline: Guideline for Good Clinical Practice (E6) (7 hrs)

• Principles of ICH GCP
• IRB/IEC
• Investigator
• Sponsor
• CRO
• Monitor
• Clinical trial protocol
• Investigator’s brochure

Unit 3

UNIT III National Regulatory Perspectives of Clinical Trials: CDSCO & Schedule Y 8 hours

Introduction and functions of Central Drugs Standard Control Organisation (CDSCO) (1 hr) Schedule Y (7 hrs)

• Clinical trial:
  • Approval for clinical trial
  • Responsibilities of sponsor
  • Responsibilities of investigator
  • Informed consent
  • Responsibilities of ethics committee
  • Human Pharmacology
  • Therapeutic exploratory trials
  • Therapeutic confirmatory trials
  • Post marketing trials
• Studies in special populations:
  • Geriatrics
  • Paediatrics
  • Pregnant or nursing women

Unit 4

UNIT IV National Regulatory Perspectives of Clinical Trials: New Drugs and Clinical Trials Rules, 2019 8 hours

New Drugs and Clinical Trials Rules, 2019 (8 hrs)

• Chapter I: Preliminary
• Chapter III: Ethics committee for clinical trial, bio availability and bioequivalence study
• Chapter IV: Ethics committee for biomedical and health research
• Chapter V: Clinical trial, bioavailability and bioequivalence study of new drugs and investigational new drugs
• Chapter VI: Compensation
• First Schedule: General principles and practices for clinical trial
• Second Schedule: Requirements and guidelines for permission to import or manufacture of new drug for sale or to undertake clinical trial

• Third Schedule: Conduct of clinical trial
• Fifth Schedule: Post market assessment
• Seventh schedule: Formulae to determine the quantum of compensation in the cases of clinical trial related injury or death

Unit 5

UNIT V Operations of clinical trials 10 hours

Submission of IND, NDA and ANDA (3 hrs)

Submission of investigational new drug application to regulatory authorities for the conduct of clinical trials, Submission of new drug application to regulatory authorities for market authorization, Submission of abbreviated new drug application to regulatory authorities to manufacture and market a generic drug

Clinical Trials Start-up Activities (3hrs)

Sample size calculation, site feasibility studies, site and investigator selection, pre-study visit, investigators meeting, clinical trial agreement execution, preparation of essential documents for clinical trial, ethics committee documents preparation and submission

Clinical Trial Procedures (4 hrs)

Procurement and storage of investigational products, site initiation visit, preparation and maintenance of master file, investigator site file and pharmacy file, electronic data capture systems, follow-up clinical trial monitoring, close-out, and archival of documents.

Unit 6

UNIT VI Quality Assurance and Quality Control in Clinical Trials 3 hours

Types of audits, audit criteria, audit process, responsibilities of stakeholders in the audit process, audit follow-up and documentation, audit resolution and preparation for FDA inspections, and fraud and misconduct management.

ASSIGNMENTS:

1. Essential documents for the conduct of a clinical trial
2. Highlights of “National ethical guidelines for biomedical and health research involving human participants, Indian Council of Medical Research, 2017”

3. Highlights of “Guidelines on similar biologics: Regulatory Requirements for Marketing Authorization in India, 2016”

Preparation of the following clinical trial documents with respect to proposed/ongoing/completed clinical trials:

4. Protocol
5. Informed consent form
6. Case report form
7. Clinical study report

Roles and responsibilities of:

8. Contract Research Organization
9. Sponsor

10. Investigator
11. Study Coordinator
12. Monitor
13. Career prospects in clinical research
14. International Pharmaceutical Regulatory Agencies
15. Scope and Challenges in Drug Development

Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those participating in the studies. This course imparts a working knowledge of clinical research. It will provide an overview of the types of clinical studies performed during the product lifecycle, and describe study design elements that support the identification of quality factors critical to ensuring the protection of study participants, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives. It will be helpful to identify the nationally and internationally accepted regulatory and ethical principles and practices in the design and conduct of clinical studies that will ensure the protection of study participants and facilitate generation of quality data and results for acceptance by regulatory authorities.

Its objective is to present the essential elements and practical methods to support the conceptualization, design, conduct, management, and reporting of clinical research. It is designed to impart the required knowledge, skills, and attitude for working effectively as a critical clinical research team player. This course is meant for candidates keen on taking clinical research as their career choice.

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

KNOWLEDGE

K1: Discuss the types and design of clinical trial.

K2: Describe the international and national regulations, guidelines and documentation related to clinical research.

K3: Outline the ethical principles and requirements in clinical research.

K4: Identify the roles and responsibilities of key players involved in clinical trial.

K5: Explain the operations of clinical trials.

K6: Illustrate the quality assurance and quality control in clinical trials

SKILL

S1: Illustrate the activities associated with clinical trials.

S2: Prepare the relevant documents related to clinical trial.

S3: Demonstrate the ethical principles in the conduct of clinical trial.

S4: Recommend the appropriate clinical study type and design.

S5: Propose the requirements for effective management of clinical trials.

S6: Manage the clinical trial coordination process.

ATTITUDE

A1: Appreciate the important principles of ethical conduct of clinical studies and the protection of participants.

A2: Appreciate the international and national regulations and guidelines related to clinical research.

A3: Participate effectively in activities related to clinical research.

A4: Provide clinical knowledge in the documentation related to clinical research.

A5: Assist in the review and approval of related documents.

A6: Support Healthcare professionals in the data collection, reporting and management of clinical trials.

REFERENCE BOOKS

1. Parthasarathi G, Karin N H, Milap C A textbook of Clinical Pharmacy Practice- essential concepts and skills, 2^nd edn. Orient Longman Private Limited, 2012.
2. Barton, C, Biron, Practical Drug Safety from A to Z. 1^st edn. Jones & Bartlett Publishers, 2017.
3. Machin D, Day S, Green S, Textbook of Clinical Trials, 2^nd edn, Wiley, 2019.
4. Kuruvilla A, Paul Clinical Trials A Beginner’s Guide. 1^st edn. Paras Medical Publisher, 2013.

ONLINE SOURCES

1. Schedule Y: Requirements and guidelines for permission to import and / or manufacture of new drugs for sale or to undertake clinical trials, Drugs & Cosmetics Rules 1945
2. New Drugs and Clinical Trials Rules, 2019
3. National ethical guidelines for biomedical and health research involving human participants, Indian Council of Medical Research, 2017
4. Guidelines on similar biologics: Regulatory Requirements for Marketing Authorization in India, 2016
5. International Conference on Harmonization of Technical requirements for registration of Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. General considerations for clinical trials. E8
6. International Conference on Harmonization of Technical requirements for registration of Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice.E6
7. International Conference on Harmonization of Technical requirements for registration of Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Structure and content of clinical study reports. E3

JOURNALS

1. Contemporary Clinical Trials, Elsevier
2. PharmacoEconomics, Springer Nature