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Related Concept Videos

Data Collection by Experiments01:13

Data Collection by Experiments

Data collection is a systematic method of obtaining, observing, measuring, and analyzing accurate information. An experimental study is a standard method of data collection that involves the manipulation of the samples by applying some form of treatment prior to data collection. It refers to manipulating one variable to determine its changes on another variable. The sample subjected to treatment is known as “experimental units.”
An example of the experimental method is a public clinical trial...
Clinical Trials01:16

Clinical Trials

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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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 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.
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Bioavailability Study Design: Healthy Subjects Versus Patients

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,...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...

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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

Clinical trial data sharing: here's the challenge.

Sonali Kochhar1,2, Bartha Knoppers3, Carrol Gamble4

  • 1Global Healthcare Consulting, New Delhi, India.

BMJ Open
|August 24, 2019
PubMed
Summary
This summary is machine-generated.

Patient data sharing platforms like Clinical Study Data Request (CSDR) show low demand and publication rates, questioning the sustainability of current models for clinical research data access. Addressing barriers for researchers and data contributors is crucial for realizing the full potential of shared health data.

Keywords:
Clinical trialsData re-useData sharing

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Area of Science:

  • Clinical research
  • Data science
  • Health informatics

Background:

  • Anonymised patient-level data is valuable for advancing scientific research and improving patient care.
  • Responsible data sharing requires effective systems for all stakeholders.
  • The Clinical Study Data Request (CSDR) platform aims to facilitate access to clinical research data.

Purpose of the Study:

  • To present summary metrics from the CSDR platform.
  • To investigate the observed low demand for shared clinical research data.
  • To challenge the research community regarding the utilization of shared data.

Main Methods:

  • Analysis of data from the CSDR platform between 2014 and January 2019.
  • Review of research proposals (RPs) submitted, approved, and leading to publications.
  • Assessment of platform metrics including application numbers and publication rates.

Main Results:

  • 473 research proposals submitted, 291 approved by the Independent Review Panel (IRP).
  • Only 41 publications reported from 90 completed analyses by January 2018.
  • Less than half of studies listed on CSDR have been requested, indicating low engagement.

Conclusions:

  • The low number of applications and resulting publications challenge the sustainability of the CSDR model.
  • Barriers for data contributors and secondary analysis researchers need identification and resolution.
  • Sustainable data sharing models are essential to unlock the full potential of shared clinical data for knowledge advancement and patient health.