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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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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...
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Cancer Survival Analysis01:21

Cancer Survival Analysis

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Cancer survival analysis focuses on quantifying and interpreting the time from a key starting point, such as diagnosis or the initiation of treatment, to a specific endpoint, such as remission or death. This analysis provides critical insights into treatment effectiveness and factors that influence patient outcomes, helping to shape clinical decisions and guide prognostic evaluations. A cornerstone of oncology research, survival analysis tackles the challenges of skewed, non-normally...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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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,...
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Treatment Resistant Cancers02:56

Treatment Resistant Cancers

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Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
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Pharmacovigilance01:19

Pharmacovigilance

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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...
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Related Experiment Video

Updated: Jul 24, 2025

Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
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Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials.

Bellinda L King-Kallimanis1, Melanie Calvert2, David Cella3

  • 1LUNGevity Foundation, Bethesda, MD, USA.

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|July 8, 2023
PubMed
Summary

Collecting patient-reported outcome (PRO) data after cancer treatment discontinuation requires clear objectives. Unjustified PRO data collection is unethical and wastes patient time and resources.

Keywords:
clinical trialsmultistakeholder perspectiveoncologypatient-reported outcomes

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Area of Science:

  • Oncology
  • Clinical Trials
  • Health Outcomes Research

Background:

  • Patient-reported outcome (PRO) data are vital for assessing cancer treatments from the patient's viewpoint.
  • The value and methods for collecting PRO data after treatment discontinuation (due to disease progression or toxicity) are not well-defined.

Purpose of the Study:

  • To describe a virtual roundtable discussion focused on PRO data collection after treatment discontinuation.
  • The event was cosponsored by the Food and Drug Administration's Oncology Center of Excellence and the Critical Path Institute in 2020.

Main Methods:

  • A 2-hour virtual roundtable convened 16 diverse stakeholders.
  • Participants included experts from academia, clinical practice, patient advocacy, regulatory agencies, health technology assessment/payers, industry, and PRO instrument development.

Main Results:

  • A key consensus was that any PRO data collection post-treatment discontinuation must have explicit, defined objectives.
  • These objectives are crucial for ensuring the collected data can be meaningfully analyzed and reported.

Conclusions:

  • Collecting PRO data after treatment discontinuation necessitates a clear justification for its utility.
  • Without a valid reason, such data collection is considered unethical, burdens patients unnecessarily, and represents a waste of resources.