Related Experiment Video

Updated: Aug 18, 2026

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
07:40

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

Published on: March 20, 2021

[Regulatory aspects of clinical trials with emphasis on biologicals]

P Volkers1, S Poley-Ochmann, M Nübling

  • 1Paul-Ehrlich-Institut, Langen. volpe@pei.de

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
|April 15, 2005
PubMed

Insights

Clinical trials are crucial for drug approval, requiring adherence to Good Clinical Practice and scientific rigor. Recent German legislation increases regulatory involvement in clinical study planning and execution.

Area of Science:

  • Pharmacology and Drug Development
  • Regulatory Science
  • Clinical Research Methodology

Context:

  • Clinical trials are essential for drug marketing authorization and demonstrating efficacy and safety.
  • Fulfilling requirements like Good Clinical Practice (GCP), scientific validity, patient safety, and transparency is critical.
  • Biologicals necessitate special considerations regarding their mechanism of action and environmental impact.

Purpose:

  • To outline the essential requirements for conducting valid clinical trials.
  • To highlight the importance of Good Clinical Practice (GCP) and scientific rigor.
  • To address specific considerations for biologicals and the evolving regulatory landscape in Germany.

Summary:

  • Successful drug development hinges on meticulously planned and executed clinical trials that meet stringent quality and ethical standards.
  • Key requirements include adherence to Good Clinical Practice (GCP), robust scientific methodology, patient safety assurance, and transparent reporting.
  • The 12th amendment to the German Drug Law (Arzneimittelgesetz) signifies increased involvement of German authorities in clinical trial oversight.

Impact:

  • Ensures the reliability and validity of clinical trial data for regulatory decision-making.
  • Promotes patient safety and ethical conduct throughout the drug development process.
  • Adapts clinical trial oversight to new legislative changes, particularly in Germany, enhancing regulatory compliance.

Related Concept Videos

Clinical Trials: Overview01:11

Clinical 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...
Clinical Trials01:16

Clinical 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...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types 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...
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
Preclinical Development: Overview01:28

Preclinical 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...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...