Tag: Clinical Trials

Improving Communication in Clinical Research

Improving Communication in Clinical Research
By: Anatoly Gorkun, MD, PhD, Chartered MCIPD
            Senior Manager, Global Clinical Development, PPD UK

Abstract: Effective communication skills in clinical research are vitally important. Due to many conflicting priorities however, clinical research professionals may not have time to manage soft skills. This increases the danger that something may go wrong. This article highlights real-life clinical research examples where communication problems affected deliverables or compliance. The principles of effective communication styles are discussed.

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Clinical Research Studies During the COVID-19 Pandemic Public Health Emergency

Corona Virus Molecule Rendering Public Health Crisis

Defining a “New Normal” in Clinical Research to Support the World’s 336,747 Research Studies

By: Jennifer Goldfarb – MSN, RN, CCRP

As of April 21, 2020, according to clinicaltrials.gov, there were 336,747 research studies registered by organizations in all 50 states and 210 countries throughout the world. Clinical Research is a delicate ecosystem within healthcare that can be easily advocated for as an essential healthcare service. It is a highly complex, intensely regulated and regimented, environment. It is a critical component of healthcare that drives scientific and medical advances to promote health and treat illness. This environment has suffered unprecedented disruption and chaos during this pandemic. While people hunker down in their homes, waiting for this storm to pass, clinical research conduct is being adapted, paused, and even discontinued, in every therapeutic area.

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FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

FDA Drug Approval Process

U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA).
As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process. Today, drugs that are approved by the FDA to be marketed in the United States are developed both in and out of the United States.

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A Modern CRA Perspective on the Use of Technology in Clinical Trials

By Takoda Roland, CCRA, CCRP

Founder of Philadelphia Pharmaceutical Research

Disclaimer: The examples noted in the following are all firsthand accounts of the author, but for the purpose of this article have been combined into a single site visit. The visit depicted below is an aggregate of many sites and studies and is not necessarily an exact representation. The original version was written entirely on a smartphone while flying from Philadelphia to Puerto Rico.

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The Future of Clinical Trials Using Electronic Data Capture Systems

Adam Donat, MS, Martin Hamilton, MSN-FNP, Irfan Khan, MS, Nichole Chamberlain, MSN-FNP

Organization:   Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring

The findings and conclusions in this article should not be construed to represent any Agency determination or policy.

Technology continues to permeate every facet of the modernized world. As the medical field relies more and more on computerized technology, unique issues have emerged especially in the area of clinical trials and the use of Electronic Data Capture (EDC). Novel approaches to safeguard data integrity and human subjects need to be considered at every juncture of the research process.

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