Clinical Investigator Sites Not Happy With Pharma Technology & Problem Worsening

Investigative sites, an Oracle survey reports, are faced with disjointed technology that slow down clinical research and hamper industry progress. Despite pervasive technology options and even major pharma consortia initiatives for site single sign-on, the overall downward trend disturbs those that are mindful of site satisfaction. All in all, the clinical trial ecosystem will pay.

Who sponsored the survey?

Oracle Health Sciences and the Society for Clinical Research Sites (SCRS)

What is the survey title?

Impact Assessment of eClinical Technologies and Industry Initiatives on Sites

What is the core problem?

There are too many sponsors and eClinical vendors with too many technologies requiring investigative site usage. The sheer number of solutions and “ballooning login credentials” make working on a trial even more cumbersome.

Core site concerns?

The survey indicated that while innovation in both clinical trial design and technology meant to improve the site and patient experience is available, investigative sites are concerned about the additional burden these technology changes bring in terms of training, complicated login processes, data duplication, etc.

Additionally sites are concerned about how to strengthen collaboration with sponsors and contract research organizations (CROs) while creating competitive edge through improved clinical trial performance.

Problem Worsening

33% of respondents reveal today’s solutions are not solving their site’s operational challenges. This is a 23% increase from a similar survey done in 2016.

Industry & Tech Vendors Don’t Get it

The survey revealed that although there are many technology options and initiative (e.g Transcelerate), 70% of investigator sites that responded to the survey don’t plan on using such technology due to A) high cost and B) complicated implementation processes.

The Nirvana Point: Single Point of Data Entry & SSO

Respondents to Oracle and SCRS reported that key priorities for sponsor technology include single point of data entry (83%) and single sign-on (74%) as the highest priority to streamline and eliminate duplicative work.

Growth of Site Networks to Improve Probability to Compete

As a consequence of growing competition among research sites to participate in industry sponsor studies, sites are trying to raise their profile to increase their chances of being selected by sponsors. 48% of investigative sites have or plan on joining site networks for a competitive edge. Sites also join site networks to access technology and improve cycle time efficiencies.

Reimagining Software for Clinical Research

Oracle’s Steve Rosenberg, senior vice president and general manager suggested that the industry must “reimagine the way that software is consumed by all stakeholders across the clinical trial continuum. Software needs to be flexible and bring to bear the best functionality need for clinical trials, regardless of modality.”

Revolution and not Evolution

Unfortunately although we think Oracle did a great job supporting this demo they and every other software vendor fall into an antiquated model when it comes to clinical trials technology. The entire model is broken and “functionality” and “features” nor modules will fix this mess. Sponsors may not have their fingers on the pulsebeats for how fast the site space is unfolding; CROs have ubiquitous presence and must be factored into any solution; industry consortia approaches to solving some of these challenges hasn’t fared too well; and the industry is transforming with the growth of personalization, precision medicine and patient-centered trial design while clinical research as a care option in the U.S. and abroad becomes more appealing.

New revolutionary approaches to clinical research are in order now (not just new technology but fundamentally new ways of doing things)—think Uber and Lyft and what they have done to the taxi cab world; think Amazon and what is going on with the American mall. Drones will change delivery and self-driving cars will fundamentally transform transport. Viva la revolución!