Clinical research in India: great expectations?
1Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, India. urmilathatte@rediffmail.com
Journal of Postgraduate Medicine
|October 28, 2008
Summary
India offers advantages for global clinical trials, including a large treatment-naïve population and cost savings. However, challenges like inadequate training and ethics oversight require capacity building and community engagement for participant safety.
Area of Science:
- Clinical Research
- Bioethics
- Public Health
Background:
- India is a preferred global clinical trial site due to its large treatment-naïve population, skilled professionals, and cost-effectiveness.
- Despite advantages, clinical research in India faces significant challenges impacting trial quality and participant safety.
- Societal concerns regarding research relevance and post-trial access persist, affecting trust in clinical research conducted in India.
Purpose of the Study:
- To analyze the key advantages and persistent challenges of conducting global clinical trials in India.
- To identify factors hindering effective clinical research and participant protection in the Indian context.
- To propose strategies for enhancing the quality and ethical conduct of clinical trials in India.
Main Methods:
- A review of existing literature and expert opinion on clinical trial conduct in India.
- Analysis of systemic issues including investigator training, ethics committee oversight, and community engagement.
- Identification of barriers to ethical research practices and participant safety.
Main Results:
- Key advantages include a large patient pool, skilled workforce, and cost benefits.
- Major challenges involve inadequate bioethics and methodology training, heavy clinical workloads, and insufficient administrative support for investigators.
- Weaknesses in ethics committee oversight and quality assurance mechanisms raise concerns about participant safety and societal trust.
Conclusions:
- Addressing challenges requires comprehensive capacity building, enhanced training for investigators and ethics committee members, and improved oversight.
- Strengthening ethics committee functioning and fostering greater community participation are crucial for ethical clinical research.
- Implementing these measures will improve the quality of clinical trials and rebuild public trust in research conducted in India.
Related Concept Videos
01:56Ethics in Research
Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
01:28Preclinical Development: Overview
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...