Adverse Events in Clinical Research

Adverse Events in Clinical Research

Safety Reporting Requirements for INDs and BA/BE Studies

This guidance is intended to help sponsors and investigators comply with the requirements for investigational new drug (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies under 21 CFR 312.32, 312.64(b), and 320.31(d)(3).  This document provides guidance to sponsors and investigators on expedited safety reporting requirements for human drug and biological products that are being investigated under an IND and for drugs that are the subjects of BA and BE studies that are exempt from the IND requirements.  This guidance defines terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides advice on other safety reporting issues that have arisen from sponsors and investigators. 

DRUG DISCOVERY AND DEVELOPMENT

Dosage Form Design: Pharmaceutical and Formulation Considerations

After reading this chapter, the student will be able to:
1. List reasons for the incorporation of drugs into various dosage forms
2. Compare and contrast the advantages/disadvantages of various drug dosage forms
3. Describe the information needed in preformulation studies to characterize a drug substance for possible inclusion into a dosage form
4. Describe the mechanisms of drug degradation and provide examples of each
5. Describe the fi ve types of drug instability of concern to the practicing pharmacist
6. Summarize approaches employed to stabilize drugs in pharmaceutical dosage forms
7. Calculate rate reactions for various liquid dosage forms
8. Categorize various pharmaceutical ingredients and excipients

Clinical Research Lectures

ETHICS IN CLINICAL RESEARCH

The health care team involved in research is ethically bound to respect human life and peoples’
autonomy. Good research practice demands that researchers must respect the rights of their subjects, listen to and share information with them, and treat them courteously and caringly.
Ethics refers to moral principles governing human character and conduct. The principles of medical ethics, introduced by Beauchamp and Childress in 1979, are as much relevant to the medical research as they are to healthcare.

Declaration of Helsinki

World Medical Association Declaration of Helsinki

The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.

The SAFETY of MEDICINES IN PUBLIC HEALTH PROGRAMMES:

Pharmacovigilance an essential tool

Public health is defined as the organized efforts of society to protect, promote and restore people’s health. It is the combination of science, skills and beliefs that is directed to the maintenance and improvement of the health of all the people through collective or social actions. The programmes, services and institutions involved focus on the prevention of disease and the health needs of the population as a whole. Public health activities change in response to variations in technology and social values, but the goals remain the same:to promote health and to reduce the amount of disease, premature death and disease related discomfort and disability in the population.

Health promotion strategies contribute to the improvement of health and the prevention of diseases in developing and developed countries alike. Public health strategy is determined in each country according to the epidemiology of prevalent diseases and the local circumstances.

The IMPORTANCE of PHARMACOVIGILANCE

Safety Monitoring of medicinal products

The purpose of this document is:

• to present the case for the importance of pharmacovigilance,

• to record its growth and potential as a significant discipline within medical 

science, and

• to describe its impact on patient welfare and public health.

It highlights the need for critical examination of the strengths and weaknesses of present

pharmacovigilance systems in order to increase their impact. It anticipates developments

necessary to meet the challenges of the next ten years. It argues that the distinctive

approaches adopted by different countries in response to their individual needs should be

supported and fostered. The document also highlights the importance of collaboration and

communication at local, regional and international levels, to ensure pharmacovigilance

delivers its full benefits. 

Pharmacovigilance and all drug safety issues are relevant for everyone whose life is

touched in any way by medical interventions. The document is intended for the following,

wide-ranging readership: 

• Policy makers at all levels of healthcare, particularly those concerned with drug policy 

• Staff and consultants in national drug regulatory authorities

• Healthcare practitioners including doctors, nurses and pharmacists

• Pharmaceutical industry executives and scientists

• Professional staff in national pharmacovigilance centres

• Editors of medical and scientific journals

• Health epidemiologists

• Health economists

• Professional staff of poison and drug information centres

• Health administrators

• Consumer groups and patient support groups

• Legal advisors in health care

• Schools of health sciences, and • The concerned layperson.

Statistical methods for clinical trials

• Overview of clinical trials
• Sample size calculation
• Cross-over trials
• Non-inferiority and equivalence trials
• Multiple testing • Group-sequential trials
• Evaluation of medical tests

15 pitfalls and how to avoid them in clinical reseach

Getting a new drug approved is becoming more difficult. Although the FDA has gotten better at

approving drugs and approving them faster, the regulatory agency is approving fewer new drug

applications. Complicating the process are many snags that could be avoided. There are 15 big

mistakes that companies commonly make in filing a new drug application. Pharmcompanies can avoid these mistakes by paying more attention.

Common Pitfalls in Multinational Clinical Trials

Multinational clinical trials are challenging. The international industry is rapidly maturing, but horror stories are still common: 

• “Our study drug is melting in a hot locker in customs, and I can’t get hold of anyone.” 
• “Sure, that country enrolled like gangbusters, but the data was garbage.” 
• “I have a hard time even understanding the local project manager on our weekly calls.” 
• “The regulatory agency responded with a single question and no details.” 
• “My highest enrolling investigator is demanding the latest iPad to keep enrolling.” 

Despite the challenges, the pressure to conduct clinical research internationally is stronger than ever. However, every country is different, with its own evolving advantages and challenges. In addition to enrollment, cost, time and sometimes even data quality advantages, countries like Poland, China, India and Brazil are rapidly expanding markets that require local trials for marketing approval. 

SECTOR PROFILE Clinical Research

The US$ 64 billion global clinical research industry is witnessing a transition since lifescience companies are turning toward emerging markets in Asia, Latin America and Eastern Europe, to pursue clinical research. Increasing costs, declining productivity and rising drug development timelines, combined with the strategic advantages offered by these emerging markets, is directing research-driven pharmaceutical and biotechnology companies to conduct clinical research beyond established markets. 

Clinical Research and its Condition in India

 This article depicts the deteriorating condition of clinical trial in India and its effect on people. In spite of having tight regulations, guidelines and various regulatory bodies to protect the volunteers and inspect the loopholes of clinical trials, the number of deaths is increasing due to SAEs. 

India_Clinical Trials New Horizon

The journey towards becoming an attractive new destination for clinical research

Regulatory Documents in Clinical Research

Clinical Trials

A clinical trial is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (vaccines, drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).  

Interviewing Tips for Clinical Research Professionals

For some of us, interviewing comes easy; for others, the mere thought of interviewing causes sweaty palms and a dry mouth.It is not that we lack the ability to do the job; it is about being prepared,selling our knowledge, experience, and skills, and finding the right match.

Clinical Trials Terminology

The following glossary of clinical trial terms is the second produced by the Glossary Group of CDISC.

• adverse drug experience
• adverse drug reaction (ADR)
• adverse event (AE)
• audit (of a clinical trial)
• case report form (CRF) etc