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

Guidelines for Writing Outcome01:11

Guidelines for Writing Outcome

When developing expected outcomes for a patient care plan, the nurse should adhere to the following recommendations:
Patient outcomes reflect the patient's response to the goal rather than what the nurse aims to achieve. Terminology should be observable and measurable to avoid the reader's interpretation. The desired outcome should be realistic and achievable in the designated care timeframe. Expected outcomes should align with adjunctive therapies. The outcome should enhance care evaluation by...
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...
The Placebo Effect01:54

The Placebo Effect

The placebo effect occurs when people's expectations or beliefs influence or determine their experience in a given situation. In other words, simply expecting something to happen can actually make it happen.
Pharmacovigilance01:19

Pharmacovigilance

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...
Nursing Evaluation01:15

Nursing Evaluation

The evaluation stage signals the end of the nursing process. The nurse gathers evaluative data to assess whether or not the patient has attained the expected results. Whereas the nurse collects data in the nursing assessment to identify the patient's health concerns, the evaluation stage data determines if the indicated health issues are resolved. Evaluative data collection includes two sections: the data acquired to evaluate patient outcomes and the time criteria for data collection.
Section...
Blind Procedures02:07

Blind Procedures

Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which child was...

You might also read

Related Articles

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

Sort by
Same author

Critical Comments by the European Medicines Agency on Patient-Reported Outcomes in Regulatory Submissions (2020-2023).

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research·2026
Same author

Sensor-based digital health technologies to capture endpoints in recent clinical trials: a scoping review.

NPJ digital medicine·2026
Same author

NASH-CHECK patient-reported outcome instrument: evaluation of content and face validity for patients with metabolic dysfunction-associated steatohepatitis and compensated cirrhosis.

Journal of patient-reported outcomes·2025
Same author

From clinical trials to informing clinical decision-making: a review of patient-reported outcomes in nononcology medicines approved by the European Medicines Agency (2018-2022).

Frontiers in pharmacology·2025
Same author

Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials - insights from an expert virtual roundtable.

EClinicalMedicine·2024
Same author

The Limitations of EQ-5D as a Clinical Outcome Assessment Tool.

The patient·2024

Related Experiment Videos

Patient reported outcomes: looking beyond the label claim.

Lynda C Doward1, Ari Gnanasakthy, Mary G Baker

  • 1Galen Research Ltd, Enterprise house, Manchester Science Park, Lloyd Street North, Manchester, M15 6SE, UK. LDoward@Galen-Research.Com

Health and Quality of Life Outcomes
|August 24, 2010
PubMed
Summary

Patient reported outcome scales are increasingly used in clinical trials for chronic conditions. This data offers value beyond labeling, influencing pricing and availability decisions by regulators, payers, clinicians, and patients.

Related Experiment Videos

Area of Science:

  • Pharmacoeconomics
  • Clinical Trial Design
  • Patient-Reported Outcomes

Background:

  • Patient-reported outcome (PRO) scales are increasingly utilized in pharmaceutical industry clinical trials, especially for chronic conditions.
  • PRO data serves as a crucial complement to traditional clinical evidence, enhancing a product's market competitiveness.
  • The value of PROs extends beyond symptom improvement, impacting regulatory decisions and market access.

Purpose of the Study:

  • To highlight the added value of patient-reported outcome data collected by the pharmaceutical industry.
  • To demonstrate the significance of PRO data for various stakeholders, including regulatory authorities, payers, clinicians, and patients.
  • To underscore the importance of PRO data in influencing the availability and pricing of medicinal products.

Main Methods:

  • Review of current practices in the pharmaceutical industry regarding the use of PRO scales in clinical trials.
  • Analysis of the role and impact of PRO data on regulatory claims (e.g., US FDA labeling, European Summary of Product Characteristics).
  • Exploration of how PRO data influences decision-making by European regulatory authorities, US and European payers, clinicians, and patients.

Main Results:

  • PRO data is essential for establishing competitive advantage and securing market access for pharmaceutical products.
  • While US FDA guidance may limit claims to symptom improvements, PRO data holds broader value for market access and pricing.
  • European regulatory authorities, payers, clinicians, and patients all recognize the importance of comprehensive PRO data beyond mere symptom reporting.

Conclusions:

  • Patient-reported outcome data collected by the pharmaceutical industry possesses significant added value for multiple stakeholders.
  • Leveraging PRO data effectively can influence product availability, pricing, and overall market success.
  • The strategic use of PRO data is critical for navigating regulatory landscapes and meeting the needs of diverse stakeholders in the pharmaceutical market.