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Related Concept Videos

Clinical Trials: Overview01:11

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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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Clinical Trials01:16

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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.
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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.
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FDA Approved Drugs: Changes to Approved Drugs01:26

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Preclinical Development: Overview01:28

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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...
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Drug Regulation01:25

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Postmarketing trials and pediatric device approvals.

Thomas J Hwang1, Aaron S Kesselheim2, Florence T Bourgeois3

  • 1Faculty of Arts and Sciences, Harvard University, Cambridge, Massachusetts; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts;

Pediatrics
|April 16, 2014
PubMed
Summary

Most high-risk pediatric devices are approved using data from adults, not children. Few post-market studies require additional pediatric patient testing before these medical devices are available.

Keywords:
childrenclinical trialdevice safetymedical devicepediatricpostmarketing

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Area of Science:

  • Pediatric medical device research
  • Regulatory science
  • Clinical trial design

Background:

  • Few medical devices are specifically approved for pediatric use.
  • The 2007 Pediatric Medical Device Safety and Improvement Act aimed to boost pediatric device development.
  • Evidence supporting pediatric device approval is not well-documented.

Purpose of the Study:

  • To describe the trial evidence used for high-risk pediatric device approvals.
  • To analyze the characteristics of clinical trials for pediatric devices.
  • To examine postmarketing study requirements for pediatric devices.

Main Methods:

  • Identified high-risk (class III) therapeutic devices approved for children (2008-2011).
  • Collected data on trial design (randomization, blinding, controls, endpoints) and participant age.
  • Reviewed US Food and Drug Administration (FDA)-mandated postmarketing trials.

Main Results:

  • 25 devices approved via premarket approval or humanitarian device exemption.
  • Most devices (88%) approved for ages ≥18, considered pediatric by FDA.
  • Trials predominantly used non-randomized, open-label designs with surrogate endpoints.
  • 84% of devices lacked studies in patients under 18.
  • Postmarketing studies were mandated for 76% of devices, but only 18% required pediatric patients.

Conclusions:

  • High-risk pediatric devices are often approved based on adult trial data.
  • Limited exposure of pediatric patients to devices before market availability.
  • Few postmarketing studies necessitate further pediatric investigation.