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

Methods of Documentation VI: Case Management Model01:15

Methods of Documentation VI: Case Management Model

1.0K
The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
1.0K
Nursing Implementation01:15

Nursing Implementation

6.5K
Implementation is the execution of the nursing care plan developed during the planning phase.
The five steps to implementing effective nursing care include reassessing the patient, reviewing and revising the existing nursing care plan, organizing the resources and care delivery, anticipating and preventing complications, and implementing nursing interventions.
6.5K
Preclinical Development: Overview01:28

Preclinical Development: Overview

6.4K
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...
6.4K
Community Based Intervention01:30

Community Based Intervention

575
Community-based interventions in mental health represent a paradigm shift from institution-centered care to treatments embedded within the fabric of local communities. By prioritizing inclusion and leveraging existing societal structures, this approach fosters a supportive environment conducive to addressing mental health challenges while promoting individual dignity and agency.
Foundations of Community Mental Health Programs
Central to the success of community-based interventions is the...
575
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
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

You might also read

Related Articles

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

Sort by
Same author

Evaluation of perinatal outcome for growth restricted fetuses.

Bioinformation·2025
Same author

Effect of Integrated Survivorship Model on Physical Health for Breast Cancer Survivors in Rural Area.

Asian Pacific journal of cancer prevention : APJCP·2024
Same author

Effect of Neural Tissue Mobilization on Sensory-Motor Impairments in Breast Cancer Survivors with Lymphedema: An Experimental Study.

Asian Pacific journal of cancer prevention : APJCP·2023
Same author

Estimation of Temporomandibular Joint Dysfunction in Oral Cancer Survivors.

Asian Pacific journal of cancer prevention : APJCP·2022
Same author

Estimation of Neural Tissue Mobility in Breast Cancer Survivors with Lymphedema.

Asian Pacific journal of cancer prevention : APJCP·2022
Same author

Analysis of Spinal Dysfunction in Breast Cancer Survivors with Lymphedema.

Asian Pacific journal of cancer prevention : APJCP·2021

Related Experiment Video

Updated: Mar 24, 2026

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits
08:27

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits

Published on: September 27, 2019

7.3K

Early access programs: Benefits, challenges, and key considerations for successful implementation.

Sanjaykumar Patil1

  • 1Subject Matter Expert, Risk Based Monitoring, TATA Consultancy Services. Vikhroli (West), Mumbai, Maharashtra, India.

Perspectives in Clinical Research
|March 9, 2016
PubMed
Summary

Early access programs (EAPs) provide ethical drug access for patients with no options. Data from EAPs informs commercial strategies and builds stakeholder relationships.

Keywords:
Early access programsnamed patient programspatients with life-threatening diseases

More Related Videos

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
06:05

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

1.8K
E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
06:28

E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

Published on: August 1, 2019

9.3K

Related Experiment Videos

Last Updated: Mar 24, 2026

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits
08:27

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits

Published on: September 27, 2019

7.3K
The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
06:05

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

1.8K
E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
06:28

E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

Published on: August 1, 2019

9.3K

Area of Science:

  • Pharmaceutical industry
  • Drug development
  • Regulatory affairs

Background:

  • Early Access Programs (EAPs) are increasingly adopted by pharmaceutical companies.
  • EAPs provide ethical, compliant access to investigational drugs before commercial launch.
  • These programs serve patients with life-threatening diseases lacking treatment options.

Purpose of the Study:

  • To outline considerations for implementing EAPs (named patient programs).
  • To review the regulatory landscape for EAPs.
  • To detail the benefits, challenges, and key success factors for EAP implementation.

Main Methods:

  • This white paper reviews existing literature and industry practices.
  • It synthesizes information on EAP implementation strategies.
  • It analyzes regulatory frameworks and stakeholder engagement.

Main Results:

  • EAPs facilitate early patient access and generate valuable data.
  • Successful EAPs require careful planning regarding regulatory compliance and stakeholder management.
  • Data from EAPs can significantly inform global commercialization strategies.

Conclusions:

  • EAPs offer significant benefits for patients, companies, and regulators.
  • Strategic implementation is crucial for maximizing EAP benefits and mitigating challenges.
  • Effective EAP management supports drug commercialization and patient access.