An Introduction to Clinical Trials and Health Policies in Biotechnology

 Biotechnology clinical trials and healthcare policies - Introduction

Clinical Research

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.




Difference between Clinical and Non-Clinical research

Clinical Research

1. Focus: Clinical research primarily deals with the study of human subjects or patients. It aims to investigate the safety, efficacy, and effectiveness of medical treatments, interventions, drugs, or devices in a real-world clinical setting.
2. Participants: Human subjects or patients are the primary participants in clinical research. These studies often involve volunteers or individuals with specific medical conditions who consent to participate.
3. Phases: Clinical research is often organized into phases (Phase I, Phase II, Phase III, and Phase IV) to systematically assess the safety and effectiveness of a medical intervention, with increasing numbers of participants and complexity as the phases progress.
4. Regulatory Oversight: Clinical research involving human subjects is subject to strict ethical and regulatory oversight to ensure the safety and well-being of participants. Regulatory agencies like the FDA closely monitor clinical trials.
5. Outcomes: Clinical research aims to generate data that can inform clinical practice, treatment guidelines, and drug approvals. The outcomes are often used to make healthcare decisions.

Non-Clinical Research

1. Focus: Non-clinical research, also known as preclinical research, involves investigations conducted in laboratory or animal settings. It is focused on understanding fundamental biological, chemical, or physical processes, often with the aim of laying the groundwork for potential clinical applications in the future.
2. Participants: Non-clinical research typically uses laboratory animals, cell cultures, or other biological systems as study subjects. Human involvement is limited or nonexistent.
3. Phases: Non-clinical research does not follow the same phase structure as clinical research. Instead, it typically involves experiments, observations, and studies designed to answer specific research questions.
4. Regulatory Oversight: While non-clinical research is subject to ethical considerations and animal welfare regulations, it does not have the same level of regulatory oversight as clinical research involving human subjects.
5. Outcomes: Non-clinical research outcomes are often foundational in nature and contribute to our understanding of basic biological mechanisms, disease processes, or the safety and toxicity of new substances. The findings may eventually lead to the development of clinical research studies.


Phases in clinical trials

Clinical studies typically go through the following four phases, as described by the FDA: 
Phase I: Researchers try to minimize adverse effects and find the ideal dosage for a novel medication or therapy. 
Phase II: After optimizing dosage, researchers examine other safety issues. 
Phase III: To make if the new approach improves patient outcomes, researchers compare the new treatment to outdated or old methods. 
Phase IV: Before a new medicine is authorized to go on sale, the Food and Drug Administration (FDA) must first approve it for testing on hundreds or even thousands of patients.


Importance of ethics in clinical research

There are several reasons why clinical research ethics are important. Ethical approaches safeguard not only the validity of the study findings but also the well-being of the patients who willingly take part in the trials. Additionally, ethical guidelines shield subjects against unfair treatment or exploitation by the study team. According to government rules, an institutional review board must approve all planned clinical trials in order to guarantee the trials' ethical conduct and the protection of participants' rights. Whether trial participants are properly told about the dangers involved and the possibility that they may not directly benefit from the study is a key ethical question when it comes to clinical trials.


How are patients selected for clinical trials?

Enrolling patients typically takes up the most time in clinical trials. Researchers are constantly looking for better methods to recruit volunteers, while maintaining the same level of clinical quality. Nevertheless, a complete sector has emerged to assist researchers in enlisting patients for their studies. For instance, Antidote is among 15 firms specializing in clinical trial recruitment, which focus on linking medical researchers with eligible patients for particular trials.

Role of healthy volunteers in clinical trial studies

The earliest human investigations of an intervention are called phase I trials. Phase I clinical studies are characterised by modest sample numbers (less than twenty), potential enrollment of healthy human subjects, and an emphasis on pharmacokinetics, pharmacodynamics, and toxicity. Because their health data can be compared, healthy volunteers give researchers vital information. In certain investigations, scientists must contrast participants in good health with those who suffer from a particular illness or condition.

Type I & Type II error in clinical trials

Type I Error is the chance of incorrectly rejecting the null hypothesis, resulting in a false positive. In superiority trials, this refers to the likelihood of mistakenly detecting a treatment effect if there is no actual treatment effect present. 

Type II Error occurs when the null hypothesis should be rejected, but it is not (i.e., a false negative). Type II error is the opposite of "power". In trials, this refers to the likelihood of not being able to detect a treatment benefit even if one truly exists.

Various types of clinical research

The FDA explains different kinds of clinical research, which consist of the following:

  • Treatment research usually focuses on exploring novel drugs, various forms of psychotherapy, medical tools, surgical procedures, and innovative interventions.
  • Prevention Research is centered on ways to halt the onset or recurrence of illnesses through medication, supplements, immunizations, and modifications in lifestyle.
  • Diagnostic research seeks efficient methods to recognize disorders and give doctors and clinicians guidelines for detecting diseases in patients.
  • Genetic research investigates how genes are connected to diseases to enhance disease forecasting and determine an individual's likelihood of developing a particular disease.
  • Epidemiological research aims to identify patterns, causes, and methods of managing diseases in specific populations by recognizing risk factors and protective factors associated with those diseases.
  • Observational studies, as defined by the NIH's National Institute on Aging, are also commonly known as clinical studies. Clinical trials involve monitoring individuals in everyday environments to categorize them based on traits and monitor developments as time progresses. The outcomes of these research often result in possible new clinical trials.

Codes of Ethics

A variety of official papers and ethical guidelines offer moral direction for clinical researchers. Some of the most notable instances are as follows:

  • The Belmont Report outlines fundamental ethical principles that support biomedical research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research created this document.
  • The Declaration of Helsinki, proposed by the World Medical Association, has been revised multiple times to tackle emerging ethical issues.
  • The Nuremberg Code was established after World War II in reaction to the unethical clinical experiments carried out by Nazi researchers. It sets a global benchmark for ethical standards in clinical research.
  • The U.S. Common Rule officially approves important safeguards for patients involved in clinical trials.

Core Principles

In addition to ethical codes, clinical researchers are guided by core principles. Some notable examples are the following:

  • Making sure that testing is thorough and completely adheres to the specified clinical protocols.
  • Checking the scientific accuracy of the findings
  • Selecting individuals for clinical trials in an unbiased and equitable manner.
  • Making sure all volunteers are completely informed about the trial procedures and possible risks before they consent.


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