Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Clinical Trials01:16

Clinical Trials

11.1K
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...
11.1K
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.4K
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...
5.4K
Trial and Error and Algorithm01:12

Trial and Error and Algorithm

480
A problem-solving strategy is a plan of action used to find a solution. Different strategies have distinct action plans. Trial and error involves trying different solutions until one works. For instance, to fix a broken printer, you might check ink levels, ensure the paper tray isn't jammed, and verify the printer's connection to your laptop. This method can be time-consuming but is commonly used. Thomas Edison, for example, used trial and error to find a suitable filament for the light...
480
Drug Regulation01:25

Drug Regulation

3.3K
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...
3.3K
Blinding01:11

Blinding

4.1K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
4.1K
Torts III01:26

Torts III

1.5K
Types of Quasi-intentional Torts in Healthcare
Quasi-intentional torts in healthcare involve acts where intent is not directed to harm an individual but results in harm due to careless or reckless speech.
1.5K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Analgesic efficacy in women and men with cancer pain, treated with strong opioids: are there differences?

BMJ oncology·2026
Same author

New demands for digital and AI skills in health occupations: a few perspectives for the future of the Istituto Superiore di Sanità (ISS). Commentary.

Annali dell'Istituto superiore di sanita·2026
Same author

CardioPulmonary resuscitation with <i>Ar</i>gon (CP<i>Ar)</i>: A protocol for a randomised controlled multicentre clinical trial.

Resuscitation plus·2025
Same author

[New European Pharmaceutical Legislation: a challenge to reconcile public health protection and market competitiveness].

Epidemiologia e prevenzione·2025
Same author

Do Not Let the Guard Down on Preventable Behavioral Risk Factors.

Journal of epidemiology·2025
Same author

Ten years after Regulation 536/2014: ethical reflection on the role of Ethics Committees in Italy.

Annali dell'Istituto superiore di sanita·2025

Related Experiment Video

Updated: Mar 26, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

11.5K

Trials, Regulation and tribulations.

Carlo Petrini1, Silvio Garattini2

  • 1Istituto Superiore di Sanità (Italian National Institute of Health), Viale Regina Elena 299, 00161, Rome, Italy. carlo.petrini@iss.it.

European Journal of Clinical Pharmacology
|January 23, 2016
PubMed
Summary

New EU clinical trial regulations aim to streamline approvals by integrating scientific and ethical reviews, avoiding conflicts of interest, and establishing efficient, coordinated ethics committees for better drug development oversight.

Keywords:
Ethics committeeEuropeRegulationTrial

More Related Videos

Traditional Trail Making Test Modified into Brand-new Assessment Tools: Digital and Walking Trail Making Test
08:07

Traditional Trail Making Test Modified into Brand-new Assessment Tools: Digital and Walking Trail Making Test

Published on: November 23, 2019

12.0K
Author Spotlight: Developing Low-Tech Balance Assessment Methods for Broad-Spectrum Healthcare Applications
06:28

Author Spotlight: Developing Low-Tech Balance Assessment Methods for Broad-Spectrum Healthcare Applications

Published on: September 1, 2023

6.6K

Related Experiment Videos

Last Updated: Mar 26, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

11.5K
Traditional Trail Making Test Modified into Brand-new Assessment Tools: Digital and Walking Trail Making Test
08:07

Traditional Trail Making Test Modified into Brand-new Assessment Tools: Digital and Walking Trail Making Test

Published on: November 23, 2019

12.0K
Author Spotlight: Developing Low-Tech Balance Assessment Methods for Broad-Spectrum Healthcare Applications
06:28

Author Spotlight: Developing Low-Tech Balance Assessment Methods for Broad-Spectrum Healthcare Applications

Published on: September 1, 2023

6.6K

Area of Science:

  • Clinical trial regulation
  • Bioethics
  • Drug development

Background:

  • EU Regulation 536/2014 separates technical-scientific and ethical assessments for trial applications.
  • The regulation mandates a single decision per Member State for trial authorization.

Purpose of the Study:

  • To propose an implementation strategy for EU Regulation 536/2014.
  • To ensure integrated scientific and ethical review processes.
  • To prevent conflicts of interest and enhance ethics committee efficiency.

Main Methods:

  • Advocating for integrated assessment of trial application Parts I and II, emphasizing scientific soundness as crucial for ethical soundness.
  • Recommending avoidance of conflicts of interest, particularly concerning national drug regulatory authorities.
  • Proposing a single, coordinating ethics committee per state, with specialized therapeutic sections.
  • Suggesting interaction between local and coordinating committees for consultation and training in biomedical ethics.

Main Results:

  • Implementation should prevent the separation of scientific and ethical assessments.
  • Conflicts of interest, especially with national drug regulators, must be avoided.
  • A single, coordinated ethics committee structure will improve efficiency.
  • Collaboration between local and central ethics committees will enhance clinical ethics consultation and training.

Conclusions:

  • The proposed implementation ensures a holistic approach to clinical trial assessment.
  • Integrated reviews and conflict-of-interest avoidance strengthen trial integrity.
  • A coordinated ethics committee system promotes efficient and ethical drug development within the EU.