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

Hazard Ratio01:12

Hazard Ratio

251
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
251
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

176
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,...
176
Regression Toward the Mean01:52

Regression Toward the Mean

6.5K
Regression toward the mean (“RTM”) is a phenomenon in which extremely high or low values—for example, and individual’s blood pressure at a particular moment—appear closer to a group’s average upon remeasuring. Although this statistical peculiarity is the result of random error and chance, it has been problematic across various medical, scientific, financial and psychological applications. In particular, RTM, if not taken into account, can interfere when...
6.5K
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

250
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
250
Analysis of Population Pharmacokinetic Data01:12

Analysis of Population Pharmacokinetic Data

387
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
387
Pharmacovigilance01:19

Pharmacovigilance

996
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
996

You might also read

Related Articles

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

Sort by
Same author

Epidemiology of WHO grade 2 and grade 3 gliomas from 2009 to 2021 in Germany.

Journal of neuro-oncology·2025
Same author

Shaping a suitable EU HTA dossier template: why the German template is not fit for purpose.

The European journal of health economics : HEPAC : health economics in prevention and care·2023
Same author

VEGF-D Downregulation in CA1 Pyramidal Neurons Exerts Asymmetric Changes of Dendritic Morphology without Correlated Electrophysiological Alterations.

Neuroscience·2020
Same author

Increased preparation time reduces, but does not abolish, action history bias of saccadic eye movements.

Journal of neurophysiology·2019
Same author

A Randomized Controlled Trial on the Effects of Aerobic and Coordinative Training on Neural Correlates of Inhibitory Control in Children.

Journal of clinical medicine·2019
Same author

Pushing attention to one side: Force field adaptation alters neural correlates of orienting and disengagement of spatial attention.

The European journal of neuroscience·2018

Related Experiment Video

Updated: Sep 14, 2025

Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation
16:02

Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation

Published on: February 10, 2023

2.8K

The PICO Puzzle: Can Public Data Predict EU HTA Expectations for All EU Countries?

Karolin Eberle1, Lisa-Maria Hagemann1, Maria Katharina Schweitzer1

  • 1AMS Advanced Medical Services GmbH, 80639 Munich, Germany; karolin.eberle@ams-europe.com (K.E.); lisa-maria.hagemann@ams-europe.com (L.-M.H.); maria.schweitzer@ams-europe.com (M.K.S.); martin.justl@ams-europe.com (M.J.); jana.maurer@ams-europe.com (J.M.); alexandra.carls@ams-europe.com (A.C.).

Journal of Market Access & Health Policy
|July 25, 2025
PubMed
Summary

Health Technology Developers can reliably predict Joint Clinical Assessment (JCA) PICO elements using public data. Anticipating comparators is key for oncology and advanced therapy medicinal product dossiers under EU HTA regulation.

Keywords:
ATMPEU HTA initiativeEU HTA regulationEuropean Access AcademyEuropean Access EnvironmentHTA bodiesJoint Clinical Assessment (JCA)PICOguidelinesinnovative health technologiesmarket accessoncology

More Related Videos

Hydra, a Computer-Based Platform for Aiding Clinicians in Cardiovascular Analysis and Diagnosis
07:51

Hydra, a Computer-Based Platform for Aiding Clinicians in Cardiovascular Analysis and Diagnosis

Published on: September 26, 2018

7.7K
TBase - an Integrated Electronic Health Record and Research Database for Kidney Transplant Recipients
09:00

TBase - an Integrated Electronic Health Record and Research Database for Kidney Transplant Recipients

Published on: April 13, 2021

4.7K

Related Experiment Videos

Last Updated: Sep 14, 2025

Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation
16:02

Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation

Published on: February 10, 2023

2.8K
Hydra, a Computer-Based Platform for Aiding Clinicians in Cardiovascular Analysis and Diagnosis
07:51

Hydra, a Computer-Based Platform for Aiding Clinicians in Cardiovascular Analysis and Diagnosis

Published on: September 26, 2018

7.7K
TBase - an Integrated Electronic Health Record and Research Database for Kidney Transplant Recipients
09:00

TBase - an Integrated Electronic Health Record and Research Database for Kidney Transplant Recipients

Published on: April 13, 2021

4.7K

Area of Science:

  • Health Economics and Outcomes Research (HEOR)
  • Regulatory Science
  • Pharmaceutical Policy

Background:

  • The European Union (EU) Health Technology Assessment (HTA) regulation mandates Joint Clinical Assessments (JCA) for specific medicinal products.
  • The PICO framework (Population, Intervention, Comparator, Outcome) defines the scope of JCAs, crucial for dossier preparation under tight timelines.
  • Health Technology Developers (HTDs) need to anticipate PICO elements early for effective dossier development.

Purpose of the Study:

  • To investigate the predictability of PICO elements for JCAs across EU member states using publicly available information.
  • To assess the availability of public data relevant for anticipating PICO requirements for HTA submissions.

Main Methods:

  • Systematic literature review to identify relevant peer-reviewed articles.
  • Extensive search of publicly available HTA documents (reports, guidelines, templates, market access information) across 29 European countries.
  • Extraction of relevant information pertaining to PICO elements for anticipation.

Main Results:

  • Significant public accessibility of HTA-related information: 66% HTA reports, 79% methodological guidelines, 69% dossier templates, and 100% market access lists.
  • Population and outcome requirements show alignment across countries, highlighting the comparator as the central element for PICO anticipation.
  • PICO elements can be reliably anticipated based on publicly accessible information.

Conclusions:

  • Publicly available data provides a reliable basis for anticipating PICO elements in Joint Clinical Assessments.
  • Health Technology Developers should leverage this information for strategic dossier preparation while remaining adaptable to evolving national procedures.
  • Proactive anticipation of PICO, particularly comparators, is essential for navigating the EU HTA landscape effectively.