Blog: Phase I

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eSource PRO: A Phase I Patient Engagement Tool

A major driver of patient recruitment hurdles in Phase I clinical trials could be described as the perceived distance between researchers and subjects. Researchers can appear only interested in mining patients for data, unconcerned with any health risks posed by a compound whose safety profile has yet to be determined. This perception is not-so-affectionately referred to as the “guinea pig…

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What Does Immunotherapy Mean for Trial Design?

It has now been a year since we first posted about immunotherapy on this blog, and several years since the first FDA approval of an immunotherapy treatment for cancer. For anyone paying attention, it’s difficult to avoid the conclusion that immunotherapy is one of today’s hottest topics not only in oncology, but in healthcare at large. Still, the treatment has…

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3 Early Obstacles in Phase I, and How to Address Them

Anyone with an involvement or interest in clinical research is likely to be aware of the challenges sponsors face in getting their compounds approved by the FDA. The low rates at which drugs make it all the way through the research process is a favorite topic of blogs and journalistic outlets covering clinical research. Many of the drugs that fall…

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Taking On a New Competitive Landscape in Phase I

Medical discoveries, major investments from the private and public sectors, and growing markets for certain treatments have taken the engines of drug development from a purr to a roar. But like any healthy industry, a byproduct of boom times is intense competition. Some CROs have, to an extent, insulated themselves from this competition by focusing on niche markets based on…

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Phase I in the Age of Precision Medicine and Patient Diversity

As clinical research evolves and becomes more refined, the industry is coming to acknowledge a simple truth: that everyone is different. A drug that works wonders for one individual may have little to no effect on, or even be detrimental to, another. Alternatively, the discovery that a treatment is ineffective or dangerous in a small group of clinical trial patients…

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How Dictionary Coding Can Enhance Phase I

Many of the challenges in clinical research stem from the experience gap between researchers and their patients. The research teams who conduct clinical trials do so with years of specialized education and training under their belt, while most participants journey through the patient experience as laypeople. This disparity creates a mandate for the development of strategies and tools that can…

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Bridging Preclinical and First-in-Human

It’s no surprise that mice are the standard subjects for preclinical research. They are real living things that have real reactions, both positive and negative, to drugs. They’re also not typically associated with the kind of emotional connection that occurs between humans and large pets like cats and dogs. In other ways, however, they are less than ideal. While their…

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Challenges and Necessities in Respiratory Drug Development

As medical science progresses, our ability to control disease typically improves. Cancer mortality rates have steadily declined over the past 25 years. Not many people in the developed world die from the common flu anymore. Numerous diseases have been eradicated altogether, thanks to vaccines and improved treatment. In this regard, respiratory disease is something of an anomaly. In just a…

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What’s in Store for Zika Virus?

Last weekend, the 2016 summer Olympics wrapped up in Rio de Janeiro. Hundreds of thousands of people from around the world had descended on the city hoping to see the top athletes from their countries snag a gold medal or two to bring home. But as Simone Biles navigated the balance beam and Usain Bolt dashed toward the finish line,…

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3 Innovative Approaches to Combat Elusive Cancers

Despite the continued advancement of immunotherapy in the fight against cancer, chemotherapy remains the gold standard of cancer treatment. For decades, oncologists have used chemotherapy to trigger apoptosis, a kind of programmed cell death that occurs naturally in the cells of healthy tissue, in cancer cells. But some of the deadliest cancers, including pancreatic and lung cancer, have been stubbornly…

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Looking for Time Savings in Phase I

Time sensitivity has long been a defining characteristic of clinical research, and is especially so today. Many of the innovations that have bolstered recent clinical trials – eSource, mobile health apps – are aimed at responding to sponsors’ concerns over study timelines, a concern sparked by rising study costs and growing markets for certain classes of drugs and other treatments.…

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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…

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Integrated Resources Uses Medrio to Reduce Study Build Time to One Day

Integrated Resources, an innovative and fast-growing CRO based in Cambridge, Massachusetts, was recently tasked with building a single-ascending-dose Phase I study of a drug to treat a rare disease, Mucopolysaccharidosis type I (MPS I). The CRO is conducting the study with Medrio’s mCore, an all-inclusive product suitable for use in all clinical phases. The study is complex, with two cohorts…

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Precision Medicine Through Technology

A number of trends may explain the enthusiasm toward precision medicine in healthcare today. Approaches to clinical trials and doctor-patient relationships are becoming increasingly user-centric. Advances in medical science have shown how to divide populations into treatment subgroups based on certain characteristics. These characteristics are often genetic in nature; precision medicine usually means identifying patient groups based on predispositions to…

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How eSource Cuts Costs

The frenzy of technological development currently taking the research industry by storm has worked wonders in the way of modernizing clinical trials. Much of this, as we discussed last week, entails the utilization of technology developed outside the industry, such as social media, to enhance patient engagement and other aspects of clinical research. But the clinical research industry’s technological savvy…

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Exploring 3 Recent Healthcare Investment Trends

Recent years have seen monumental developments across the healthcare landscape. New technology is rapidly changing the way we treat and study disease. Changes in dietary trends and other lifestyle factors can cause spikes in some diseases and conditions while sending others the way of the dodo. With changing trends in health and sickness come changing investment trends in medical research.…

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The Growing Trend Toward Patient Engagement

The global economy, catalyzed by technology, is becoming increasingly consumer-centric. Social media and mobile applications are putting the ball in the customer’s court across industries ranging from transportation to legal counsel to hospitality. The clinical research industry has its analogy to this trend in the rise of patient engagement. A recent eyeforpharma report notes that the vast majority of pharmaceutical…

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Medrio Quick Facts

As eClinical data management continues its march toward becoming the norm in clinical research, the landscape becomes increasingly populated with companies offering EDC. It can be difficult for EDC providers to stand out among broadening competition. Here at Medrio, we’ve grown with the times and created a model that has kept us unique as the industry develops. Here’s a quick…

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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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A Potential Breakthrough in Neurological Research (Infographic)

In recent years, neurodegenerative diseases have gained prominence not just in the scientific community, but in pop culture. Films like Concussion and Still Alice investigated the subject from the perspectives of researchers and patients; actor Seth Rogen has become a high-profile advocate for Alzheimer’s research, even taking the cause before Congress in 20141. This attention is not unwarranted. Neurodegenerative diseases…

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The Rise of eClinical: What Opportunities Are Presented?

In December of 2014, Sandra Freeman, writing for Applied Clinical Trials, predicted that 2015 would prove to be the year of eClinical, with a reduction in paper usage and a rise in eSignatures resulting in faster study start-up time1. According to Globe Newswire, by 2020, eClinical will be a nearly $6 billion-industry2. All this points to what is, for many,…

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Can Technology Allay Safety Concerns In Phase I?

The FDA reports that 70% of drugs in Phase I trials ultimately make it to later phases of clinical research1. This number may look impressive until one remembers the primary purpose of a Phase I study: to determine if a treatment is safe and well-tolerated in humans. If 70% of drugs tested in Phase I move on to Phase II,…

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Rare but Meaningful Efficacy Findings in Phase I Oncology Trials

A Phase I trial for a cancer treatment is, almost by definition, emotionally loaded territory. Unlike other Phase I trials, which test a new treatment on healthy volunteers, cancer trials involve patients who are presently battling the type of cancer the treatment is designed to target1. What’s more, a typical participant in these trials has already exhausted all standard treatments…

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The Immunotherapy Revolution

Immunotherapy characterizes the most promising cancer treatment approach since chemotherapy was developed in the late 1940s. While the potential that immunotherapy holds has been understood for more than a century, it is only recently that multiple agents for the treatment of cancer have been approved.1 The last few decades have shown an advancement in immunotherapy, but newer types of immune…

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Harnessing the Power of eSource for your Clinical Trials

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Understanding Phase I

Infographic: Understanding Phase I Clinical Trials

Developing an FDA approved drug or device is a long and expensive process. Researchers and pharmaceutical companies spend years bringing a drug to your medicine cabinet. Most drugs that undergo preclinical research never make it past this phase. The ones that do make it have to go through three phases of human testing before they are presented to the FDA…

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Proven: Medrio is the Right Choice for Phase I

Bringing a drug from the clinical trial stages to market is a long and expensive process, which is why sponsors often streamline the process by outsourcing their clinical trial management to contract research organizations (CROs). ClinDART, a small CRO based in San Diego, provides its pharmaceutical, biotech, and medical device company clients with the necessary flexibility, extensive knowledge, and expertise…

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Addressing Safety in Phase I Clinical Trials

The purpose of conducting a Phase I trial is to test a new drug or treatment on human subjects for the first time in order to determine its safety, evaluate side effects, and ascertain the correct dosage level.  It is important to be sure that each drug or device that is being tested is safe before moving forward with the…

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How the Internet of Things Will Transform Phase I Clinical Trials

Over the last few years, smart, connected products have become part of our everyday lives. We can hardly remember a time when our phones, watches, and TVs were not connected to the internet and providing us with real-time data. The phrase “Internet of Things” (IoT) has developed as a way to categorize the growing number of smart products that have…

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The Frightening Cost of Paper (Infographic)

Electronic data capture (EDC) has been an available solution for data management in clinical trials for the past decade. During this time, EDC has proven to be more efficient, straightforward, and less expensive than the alternative: paper. Efficient use of resources is especially important to Early Stage and Phase I studies, where budgets are small and timelines are tight. With…

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Phase I Collaboration: PharPoint Research & Medrio CloudEDC™

In our last article with PharPoint Research, we discussed how being first to market is essential, as first-movers usually acquire significantly greater market share. Having a contract research organization (CRO) that guarantees fast timelines, while simultaneously mitigating the risk of errors, means deadlines will be met and provides a clear competitive advantage (something that can be difficult in this industry).…

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Using Social Media to Recruit Subjects in Phase I Clinical Trials

Phase I Recruitment Issues Subject recruitment in all phases of clinical research can be costly and time consuming, but it can be especially problematic in Phase I studies.  Phase I trials primarily test for safety, so they tend to pose greater risk than later phase studies. Furthermore, participants in Phase I trials do not experience any therapeutic benefit from treatment,…

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The Top 5 Cost-Drivers in Phase I Clinical Trials

Greater Phase I Complexity, Greater Phase I Costs Clinical trial costs have skyrocketed over the past decade with early phase trials showing the greatest per-patient cost increase of any category, on both a raw dollar and percentage basis. In fact, from 2008 to 2013, the average cost per patient increased by $23,600, or by 157%. In Phase I trials compared…

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Innovative Study Design in Phase I: Adaptive Clinical Trials

Smarter Science, Smarter Study Design We all know that some drugs work better for certain age groups, genders, and other demographic categories. But what if a drug works well for just a tiny subset of patients within an already targeted group?  How do we identify these patients in a big sea of participants? Nowhere is this question more important than…

Accelerating Clinical Trials: A Rich Reward

The commonly accepted figure for sales of a new drug is $1M per day. Thus, every day saved in bringing a new drug to market yields significant returns. As days turn into weeks, months, and years, the additional earnings add up and become massive. A few months can make the all-important difference between first and second to market. The industry move from…

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