Related Experiment Video
Updated: Jun 18, 2025
00:04
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
10.6K
Improving Access to Patient-Focused, Decentralized Clinical Trials Requires Streamlined Regulatory Requirements: An
Ramya Thota1, Patricia A Hurley2, Therica M Miller3
1Intermountain Health, Murray, UT.
Summary
Decentralizing cancer clinical trials improves patient access but faces regulatory hurdles. Streamlining administrative and regulatory requirements is crucial for broader participation and modernizing trial standards.
Area of Science:
- Oncology research
- Clinical trial management
- Regulatory science
Background:
- Decentralized clinical trial strategies gained traction during the COVID-19 pandemic.
- Implementing decentralized elements offers opportunities and challenges in regulatory, technical, and operational domains.
- Regulatory and administrative burdens are identified as critical barriers to decentralizing oncology trials.
Purpose of the Study:
- To provide consensus-driven recommendations for overcoming barriers in decentralizing clinical trials.
- To engage research stakeholders in modernizing trial standards and administrative processes.
- To address the disproportionate use of regulatory tools like the FDA's Form 1572 in decentralized trials.
Main Methods:
- Convened multistakeholder meetings with leaders in oncology research.
- Analyzed regulatory and administrative requirements impacting decentralized trials.
- Developed consensus-driven recommendations for streamlining processes.
Main Results:
- Regulatory and administrative burdens, including conservative use of Form 1572, create significant downstream activities for research sites.
- Identified four key solutions to modernize standards and facilitate local trial access.
- Highlighted the need for public-private partnerships and updated policies for decentralized trial implementation.
Conclusions:
- Simplifying and streamlining regulatory requirements and practices is essential for broadening access to cancer clinical trials.
- A concerted commitment from the research community is needed to implement decentralized trial elements effectively.
- Modernizing standards and administrative processes will enhance patient participation in oncology research.
Related Concept Videos
01:11Clinical Trials: Overview
2.9K
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...
2.9K
01:16Clinical Trials
6.6K
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...
There are four phases in a clinical trial. A phase one...
6.6K
01:28Preclinical Development: Overview
4.3K
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...
4.3K
01:25Drug Regulation
1.3K
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...
1.3K
01:29Issues And Trends In Healthcare Delivery System
5.6K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
5.6K
01:03Drug Control Governance: Regulatory Bodies and Their Impact
148
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
148