Blog: Regulation & Ethics

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What Are the eClinical Implications of the New EU Data Regulation?

A recent article in Clinical Leader outlined concerns about Pharma’s ability to comply with the new EU Data Protection Regulation set to go into effect in May 2018. Indeed, companies doing business in the European Union will have major regulatory changes to contend with, including: Increased territorial scope, which includes where data is processed and stored Increased penalties, which can…

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Monthly News Roundup: August 2017

Welcome to the Medrio Monthly News Roundup, in which we brief you on a sample of events and developments taking place around the industry. This recurring update functions on popular demand – the stories in this post come from the articles in our social media feeds that garnered the most attention from our readers and followers. Your likes, clicks, and…

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3 Considerations as Clinical Trials Go Global

Ask an economist to name the most defining business trend of the 21st Century, and there’s a strong chance the answer will be globalization. Nations and regions are becoming increasingly intertwined through trade and outsourcing. Clinical research is no exception to this trend. Multi-country clinical trials have risen in recent years, and new regions have emerged as today’s most promising…

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Monthly News Roundup: December 2016

Welcome to the Medrio Monthly News Roundup, in which we brief you on a sample of events and developments taking place around the industry. This recurring update functions on popular demand – the stories in this post come from the articles in our social media feeds that garnered the most attention from our readers and followers. Your likes, clicks, and…

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Another Side of Patient Engagement

The patient engagement craze in clinical research today is largely driven by recent technological innovations. An app allows patients to track their symptoms on their own time, providing clinical data in a passive and convenient fashion. Social media is explored as a new avenue through which to recruit patients for an upcoming trial. These developments have shown great promise in…

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New Potential Leads to New Challenges in Pharma Today

Almost a quarter million clinical trials worldwide are registered on the database ClinicalTrials.gov. Today’s top treatments and diseases are seeing billions of dollars in investments from venture capitalists, governments, and others. Recent outbreaks of infectious diseases like Zika virus and Ebola have stoked demand for more, and faster, drug development. All of this points to boom times in clinical research.…

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Letting Clinical Trial Patients Do the Talking

In this era of booming technology, principal investigators of clinical trials have tried all sorts of things to overcome persistent patient recruitment hurdles. Their approaches include study websites, outreach through social media, apps helping willing clinical trial patients find appropriate clinical trials, and more. Enrollment rates, however, remain less than ideal, and recruitment continues to occupy a hefty chunk of…

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A New Frontier in Cardiac Safety Analysis

Amidst the groundbreaking technological advancements that clinical research has seen in recent years, there are still some areas in which the industry is looking for improvements. One of these is FDA approval rates. Only about ten percent of drugs that enter clinical trials ultimately make it to market, rendering lost the years and, often, billions of dollars spent developing many…

Clinical Trial Regulations

Clinical Trial Regulations: EU vs. US

Like in many other industries, business relationships in clinical research frequently span international borders. It’s common practice for a sponsor based in one country to conduct a study in another, due either to cost advantage, market opportunity, or other factors. When this happens, though, researchers must be vigilant in becoming familiar with, and adhering to, the regulations governing clinical trials…

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A Look at Voluntary Reporting Practices

It’s standard practice for governments around the world to impose reporting requirements on clinical trials conducted in their countries. And while the regulatory apparatus of one country may differ from that of another, there is a common thread throughout the West: the occasional failure of clinical trials to report their results is well-publicized. While media coverage of the issue often…

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Registration and Publicity in Phase I

About a month ago, we published a post examining the friction, in clinical trials, between the demand for transparency and the protection of confidentiality. Regulators recently published guidelines for reporting the results of European clinical trials; in the U.S., there have been calls for improved compliance with reporting requirements1. This is a discussion that often focuses on the back end…

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Coverage Policy: Boosting or Busting Clinical Recruitment?

There are numerous obstacles that stand in the way of patient recruitment for clinical trials. This is neither a secret in the clinical research industry, nor is it difficult to understand. After all, at face value, being the subject of an experiment studying the unknown effects of a controlled substance may not, frankly, sound so appealing. Efforts to address this…

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Transparency vs. Confidentiality

With several exceptions, the FDA requires that studies of drugs and devices be registered, and their results reported, by their sponsors or principal investigators1. But there is often a tug-of-war, in the clinical research field, between researchers who value confidentiality in trial results and governments and advocacy groups who demand transparency2. The issue is complex, with various interests coming into…

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The Open Data Revolution in Clinical Research

Where Is All the Clinical Trial Data? Only about half of clinical trials make their way into medical journals, and even when studies are published the raw, patient-level data is rarely made available. Where is the missing data? Most of it is tucked away deep in the data vaults of pharma and medical device companies, never to see the light…