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

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

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

373
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,...
373
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

121
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
121
Clinical Trials01:16

Clinical Trials

10.1K
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...
10.1K
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.5K
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...
4.5K
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

836
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
836
Pharmacovigilance01:19

Pharmacovigilance

1.6K
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...
1.6K

You might also read

Related Articles

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

Sort by
Same author

Validation of the Infant and Young Child Development (IYCD) Indicators in Three Countries: Brazil, Malawi and Pakistan.

International journal of environmental research and public health·2021
Same author

Creation of the WHO Indicators of Infant and Young Child Development (IYCD): metadata synthesis across 10 countries.

BMJ global health·2018
Same author

Optimizing primary care management of atrial fibrillation: The rationale and methods of the Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF) study.

American heart journal·2018
Same author

Statistician credit for collaboration requires extending the number of cited authors in research publications.

Journal of clinical epidemiology·2018
Same author

Survey of professional views on sharing interim results by the Data Safety Monitoring Board (DSMB): what to share, with whom and why.

Trials·2018
Same author

A clinical carepath for obese pregnant women: a pragmatic pilot cluster randomized controlled trial.

The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians·2018
Same journal

Immersive physical and occupational therapy in the neonatal intensive care unit: a non-randomized comparative cohort trial protocol.

Pilot and feasibility studies·2026
Same journal

Nonpharmacological multicomponent intervention for mild cognitive impairment with a family-patient approach: protocol for the pilot clinical trial-INTERCOG study.

Pilot and feasibility studies·2026
Same journal

A pilot study investigating the feasibility of a positive body image yoga intervention for men and women across adulthood.

Pilot and feasibility studies·2026
Same journal

A single-session consultation to enhance mental health treatment engagement in patients with comorbid physical and mental problems: study protocol for a pilot randomized controlled trial.

Pilot and feasibility studies·2026
Same journal

Weight management in obese cancer patients during curative active treatment: protocol for the CANOBESE feasibility study.

Pilot and feasibility studies·2026
Same journal

Remote versus face-to-face delivery of the Group Triple P parenting programme: a feasibility non-randomised trial.

Pilot and feasibility studies·2026
See all related articles

Related Experiment Video

Updated: Jan 5, 2026

Collecting Sleep, Circadian, Fatigue, and Performance Data in Complex Operational Environments
08:36

Collecting Sleep, Circadian, Fatigue, and Performance Data in Complex Operational Environments

Published on: August 8, 2019

12.6K

Guidelines for reporting non-randomised pilot and feasibility studies.

Gillian A Lancaster1, Lehana Thabane1

  • 1School of Primary, Social and Community Care, Keele University, Newcastle-under-Lyme, UK.

Pilot and Feasibility Studies
|October 15, 2019
PubMed
Summary
This summary is machine-generated.

Reporting guidelines for non-randomised pilot and feasibility studies are essential for consistent research. This editorial recommends adapting the CONSORT extension for pilot and feasibility trials to improve reporting quality.

More Related Videos

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

11.1K
A Methodological Protocol and Considerations for Transcranial Ultrasonic Stimulation in Exploratory Clinical Human Studies
09:34

A Methodological Protocol and Considerations for Transcranial Ultrasonic Stimulation in Exploratory Clinical Human Studies

Published on: December 12, 2025

107

Related Experiment Videos

Last Updated: Jan 5, 2026

Collecting Sleep, Circadian, Fatigue, and Performance Data in Complex Operational Environments
08:36

Collecting Sleep, Circadian, Fatigue, and Performance Data in Complex Operational Environments

Published on: August 8, 2019

12.6K
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

11.1K
A Methodological Protocol and Considerations for Transcranial Ultrasonic Stimulation in Exploratory Clinical Human Studies
09:34

A Methodological Protocol and Considerations for Transcranial Ultrasonic Stimulation in Exploratory Clinical Human Studies

Published on: December 12, 2025

107

Area of Science:

  • Medical Research Methodology
  • Clinical Trial Reporting
  • Health Sciences

Background:

  • Increasing submissions to Pilot and Feasibility Studies necessitate improved reporting standards.
  • Existing CONSORT extension (2016) addresses randomized pilot/feasibility trials, but gaps remain for non-randomized designs.
  • This editorial provides guidance for reporting common non-randomized pilot and feasibility studies.

Discussion:

  • Recommends the CONSORT extension for pilot and feasibility trials as the primary reference document.
  • Suggests adapting or omitting inapplicable items from the CONSORT extension for non-randomized studies.
  • Highlights the value of supplementary guidance from EQUATOR Network checklists.

Key Insights:

  • Adaptation of the CONSORT extension is a viable strategy for reporting non-randomized pilot and feasibility studies.
  • Clear reporting guidelines enhance the consistency and utility of pilot and feasibility study reports.
  • Utilizing resources like the EQUATOR Network can further refine reporting practices.

Outlook:

  • Aims to standardize the reporting of diverse pilot and feasibility study designs.
  • Encourages researchers to adopt recommended reporting practices for better scientific communication.
  • Facilitates more consistent and helpful dissemination of preliminary research findings.