INTRODUCTION TO CLINICAL RESEARCH REGULATIONS: UNDERSTANDING THE REGULATORY LANDSCAPE

INTRODUCTION

➢ Clinical research is a branch of healthcare science that determines the safety and effectiveness [efficacy] of medications, devices, diagnostic products and treatment regimens intended for human use 

➢ These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease

➢ Clinical research is different from clinical practice.

➢ In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.

➢ Clinical trials involving new drugs are commonly classified into four phases.

➢ Each phase of the drug approval process is treated as a separate clinical trial.  

➢ If the drug successfully passes through Phases I, II, and III, it will be approved by the national regulatory authority for use in the general population. Phase IV is post-approval studies.  

 

         WHY ARE THEY IMPORTANT?

➢ Clinical trials are a critical part of evidence-based medicine, as they help test out how new medical treatments, test or vaccines will work. They often involve large numbers of people to make sure the new intervention is safe and effective.

      REGULATORY FRAMEWORK

      GOOD CLINICAL PRACTICE [GCP]

➢ GCP is an international quality standard, which the government can then transpose into regulations for clinical trials involving human subjects. 

➢ GCP guidelines include protection of human rights for the subjects and volunteers in clinical trials.

➢ GCP follows the International Council for harmonization of Technical Requirements for Pharmaceuticals for Human Use [ICH] and enforces tight guidelines on ethical aspects of clinical research. 

➢ High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computer and software.

  INTERNATIONAL COUNCIL FOR HARMONISATION [ICH]

➢ ICH is an initiative that brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of Pharmaceutical product development and registration.

➢ The mission of the ICH is to promote public health by achieving greater harmonization.

➢ Harmonization leads to a more rational use of human, animal, and other resources.

➢ The elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health.

REGULATORY BODIES

       FOOD AND DRUG ADMINISTRATION

➢ FDA is a federal agency of the Departmental of Health and Human Services

➢ The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act [FD and C].

➢  The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, etc.

➢ The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate.

      EUROPEAN MEDICINES AGENCY[EMA]:

 

➢ The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products.

➢ Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).

➢ Formed on 1 January 1995; 28 years ago

➢ The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention is to harmonize (but not replace) the work of existing national medicine regulatory bodies.

 REGULATORY LANDSCAPES

➢ Regulators desire good proof-of-concept studies, leading to representative clinical trials that can then, in turn, result in appropriate clinical practice guidelines and performance measures.

➢ Regulators are also increasingly focused on sustainability, which may be achievable by simplifying trials and enrolling representative populations through the use of real-world data or drug-product monitoring registries.

➢ Another way to help sustainability is early health technology assessment (HTA) evaluation. 

➢ Integrating clinical research networks is one way to ensure more efficient trials.

➢ The patient's voice in particular has become increasingly important to regulators in defining the value of a medicine, yet incorporating patients' viewpoints into clinical trials may further increase the complexity of those trials.

➢ Regulators have been pushing for increased data sharing to promote efficiency and ensure continued progress.

➢ There is a need for new regulatory approaches for combining passive and experimental data that would meet the needs of the 21st century.

➢ Drug-product monitoring registries enable tracking of longitudinal outcomes and adverse effects.

➢ Randomization with a registry enables real-world testing of hypotheses.

 

 REFERENCES

 

•  Introduction to Clinical Research Informatics", Rachel Richesson, James Andrews

•  https://health.ec.europa.eu/medicinal-products/clinicaltrials/clinical-trials-directive-200120ec_en 

• Gottlieb, Scott (June 19, 2018). "Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply" (Press release). Food and Drug Administration. Archived from the original on July 24, 2018. Retrieved June 20, 2018 

• Morgan, Sam (23 March 2017). "Romania looks to poach EU medicines agency from UK". Euractiv. Retrieved 8 May 2017.

 

 

 Student Name: Y. Nuthana

Student ID: 177/082023

Qualification: B. Pharmacy