ARTICLES BY BETH HARPER

• A Rose By Any Other Name … What Is A CRA Anyway?

  1/5/2021

  Ask any project team, or CRA for that matter, what the expectations are for this role and you’ll get vastly different answers. For many, the CRA is an all-knowing, all-purpose expert with a broad range of responsibilities. For others, the role is more focused on the monitoring and compliance aspects of study conduct.

• Capacity & Competency Of The Clinical Research Workforce — Today & Tomorrow

  9/29/2020

  It’s not simply an issue of supply and demand. It’s closer to life and death. Put bluntly, we may not be able to keep up with future clinical trial demand because our workforce isn’t growing fast enough. In fact, by some metrics, we’re already falling behind.

   

• Rethinking Recruitment Plans During The Pandemic

  4/7/2020

  Once the care and management of current clinical trial participants have stabilized, we can find some silver linings in the pause. Sponsors and CROs can use this opportunity to rethink their recruitment plans, support site sustainability, and intelligently prepare for the ultimate ramp up of trial enrollment.

• Free-From-Harm Training: Protecting Patients & Creating Competencies In Clinical Trials

  2/20/2020

  The basics of medical practice are to do no harm, and the core tenets of GCPs are to protect the rights, safety, and well-being of the trial subjects. When training doesn’t allow for practicing clinical research competencies in a safe environment, then we are in danger of violating the principles we are trying to teach.

• The Myth Of Disruptive Innovation In Clinical Trials: Time For A More Disciplined Approach

  11/21/2019

  At the outset, let me state for the record that I’m a big advocate for change. My threshold for accepting “that’s the way we’ve always done things” is actually quite low. But I confess that I’m getting a bit dizzy, dismayed, and, to be frank, disappointed with all the so-called “disruptive innovation” taking place in the industry. First and foremost, I don't really think that anything taking place really qualifies as disruptive.

• 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.

• Talent Wars: How To Develop A Competent Clinical Research Workforce In A Competitive Environment

  12/18/2018

  A booming economy brings opportunities, and the biotech industry is booming. But with that comes challenges, particularly with regard to finding qualified candidates to fill the growing number of jobs.

• From Cowardly Lions To Courageous Decision Makers: What ClinOps Needs Now

  10/25/2018

  Fall is in the air, and Halloween is just around the corner. I always associate Halloween with “The Wizard of Oz.” When I grew up, Halloween meant reruns of the movie and was a highly anticipated annual family viewing event. Dorothy, the Wicked Witch of the West, those creepy flying monkeys, and, of course, the Wizard. We all had our favorite characters, and my poor parents had to contend with my post-movie nightmares for days. But it’s the Cowardly Lion who's been on my mind recently. 

• Precise Patient Recruitment Planning – It’s All About The Patient Pathway

  8/28/2018

  At this stage in my career, I confess that I’ve lost track of the number of publications and presentations I’ve developed and delivered on the topic of patient recruitment. Many of these have focused on lessons learned from troubleshooting hundreds of trials in “rescue mode.” As I reflect on why so many recruitment campaigns or efforts fail to deliver the expected results, a common root cause issue points to the lack of understanding of the importance of, and how to create, a meaningful patient pathway. This terminology may mean different things to different individuals and organizations and may be used interchangeably with patient journeys.

• A Simulation-Based Approach To CRO Selection

  6/21/2018

  Protocol or clinical trial simulations have been on the radar screen of the industry for quite some time as a technique for optimizing trial design and decision making.

• Training As A Site Engagement Strategy

  4/26/2018

  Raise your hand if you are a sponsor/CRO that wants to be the organization of choice for investigative sites. Now, raise your hand if you put your sites through endless hours of Web or e-learning training as part of the study start-up process. This is just one of several surefire ways to kill a site’s enthusiasm and commitment to working with you or on your studies. Another, for the record, is sending ill-prepared clinical research associates (CRAs) who are not training specialists to do the PowerPoint death march at site initiation visits (SIVs)!

• Competencies And Credentialing And Certification … Oh, My!

  2/6/2018

  In his recent column, Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP), challenged the industry to address the need to raise the standards of professionalism of the clinical research workforce.

• What Improv Comedy Can Teach Us About Communication In Clinical Trials

  1/11/2018

  Over the holiday season, I took the time to reflect on the whirlwind and craziness of the past year. I don’t know about you, but I was ready for some comic relief, so I indulged in one of my favorite pastimes -- attending an improv comedy show. It’s been 10 years since the original Whose Line Is It Anyway ended its successful run as a TV show (much to my chagrin), but Saturday Night Live is alive and well after 40 years.

• Why Staff-Centricity Needs To Be Front And Center On Your Radar In 2018

  11/9/2017

  As 2017 comes to an end, I have been reflecting on the topics I’ve covered this year, focused mainly on patient- and site-centricity.  It occurred to me that as an industry, we’ve been missing the topic of staff-centricity for quite some time.  Patient engagement officers and related roles are becoming more commonplace, and many service providers have a variety of personnel focused on customer engagement.  But it’s rarer to hear about employee engagement officers. 

• A Critical Juncture For Clinical Trial Data Management

  11/2/2017

  Data management functions are managing a much higher volume and diversity of data in response to the increasing scope and demands of global drug development programs. Real-world data and evidence, electronic clinical outcome assessments, data from smartphones and mobile devices, social media community data, and electronic health/medical records are examples of the variety of new data sources now captured during a clinical trial.  The volume and diversity of data presents integration, compatibility, and interoperability challenges that must be optimized to improve drug development performance and efficiency.