Clinical Guest Contributors

71. Can Virtual Clinical Trials Democratize Medicine? 5/3/2019

    There are over a quarter million active clinical trials registered with the FDA right now, up from just 1 percent of that figure at the turn of the century. It's a $65 billion industry – clinical trials alone, that is, and it's only going to get bigger.

72. Teaching Old Dogs New Tricks: Can Competency With Clinical Research Technologies Be Enhanced? 4/30/2019

    Many workplaces are composed of five generations, from traditionalists to Generation Zs. While this can lead to a host of communication, productivity, and other issues, the challenges are perhaps never more apparent than with the introduction and use of new technologies. In fact, this has led some to claim age isn’t the deciding factor when it comes to describing how proficient people are with digital technologies and culture.

73. Building And Applying A Configurable Clinical Study Model 4/25/2019

    Last month we introduced an approach for the rapid assessment and prototyping of digital and other clinical trial technologies. Advances in technologies and digital innovations targeting the clinical research environment are evolving at dizzying rates, and the need to efficiently assess and implement opportunities is greater than ever.

74. Getting A Handle On Clinical Trial Costs 4/25/2019

    Recently, clinical trials have become very complex affairs, especially for small and medium biotech companies. There are many factors behind this, including, but not limited to, increased costs and regulatory requirements. According to Tomasz Sablinski, CEO at Transparency Life Sciences, the cost of clinical trials increased by around 100 percent from 2008 to 2019. A study published in JAMA Internal Medicine in 2018 found that out of 138 pivotal trials assessing 59 new therapies that received FDA approval between 2015 and 2016, there was a more than 100-fold difference in the costs of clinical trials.

75. 3 Powerful Writing Tips that Will Significantly Improve Your Clinical SOPs 4/18/2019

    In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success. I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.”

76. A Patient-Centric Approach To Increase Recruitment And Retention In Clinical Trials 4/16/2019

    Good recruitment and retention is critical to the success of clinical trials. Get it right, and a trial will likely achieve its primary objective; get it wrong, and the time, effort, expense, and any patient participation is likely wasted. This article discusses how a new national approach to involving patients and the public in the U.K. is helping life sciences companies get it right the first time.

77. Biopharma Precompetitive Collaboration: Optimizing Clinical Trial Quality, Efficiency, & Excellence 4/11/2019

    Developing new, innovative pharmaceutical agents to address global health needs is becoming more complex, challenging, and costly. As the industry attempts to adapt and gain value for patients, healthcare providers, and other stakeholders, technologies, digitization, real-world data, immediate access to clinical trial data, and the adoption of wearable devices provide both opportunities and challenges. Disparate attempts to incorporate these capabilities across pharma, biotech, contract research organizations (CROs), regulators, and investigative sites create confusion and frustration while frequently adding unintended costs and quality issues.

78. How To Spec, Purchase, And Implement The Right IRT System For Your Clinical Trial 4/11/2019

    During a study startup phase, interactive response technology (IRT) system development can be difficult for clinical teams to navigate successfully, especially when team members have limited experience building or using the technology. Take a deeper dive into key considerations when selecting a vendor, strategies to implement during the IRT design phase, and best practices for utilizing the system throughout the life of your trial.

79. An Insider’s Guide To Interactive Response Technology (IRT) For Clinical Trials 4/4/2019

    During a study startup phase, interactive response technology (IRT) system development can be difficult for clinical teams to navigate successfully, especially when team members have limited experience building or using the technology. An experienced project manager shares some lessons he has learned to empower clinical team members to make better decisions when it comes to this crucial technology and in the end develop better and safer systems.

80. Considering The Needs Of The Caregiver In Drug Development 4/2/2019

    There has been an increasing and requisite focus on the needs of individuals affected by chronic or life-limiting disease, which has in turn resulted in a focus on the development of possible interventions and how they are administered. The success of participation and retention of these patients in clinical research, advancement of the drug development process, and adherence post-commercialization require the involvement of another critical expert — the caregiver.