The Evolution of the ‘Site-Less’ CRO and Why We Need It

Whether it is Uber’s upending of transport or Airbnb’s disruption of the lodging industry, upstarts are combining technology and business models in new ways to change our world.  This is also true in the healthcare industry which has recently introduced the concept of the virtual or in-home clinical trial and ‘site-less’ clinical trial research organization.

Why is a site-less CRO necessary in today’s clinical trial world?

Site-less CROs diffuse an often times complex and frustrating experience for patients, investigators and sponsors.  For example: many potential patients refuse to participate in clinical trials due to broken trust and a fear they will be treated like guinea pigs.  In addition, many Contract Research Organizations (CROs) and sites are redundant intermediaries adding costs, extending timelines and diverting resources that could be better spent on patient care.  Lastly, most clinical trial sites are in major urban centers on the East Coast and West Coast as well as Chicago and Houston which results in limited access for patients living in the center of the US.

There’s more:

• 80% of clinical trials never get past the recruitment phase.  Challenges finding suitable patients often mean a trial never makes it to the point of submission to the FDA, even for approval to conduct a follow-on trial.¹
• 40% of patients in Phase III trials will drop out due to issues such as challenges relating to meeting all the requirements of a study, traveling to provider appointments, or complex requirements for data collection.²
• $75,000 is a normal cost for initiating and managing and closing out a site’s participation in a trial, whether the site is able to recruit patients or not. Note: 50% of sites never recruit a single patient.³

We as an industry can do better.

One of the most exciting concepts is the virtual clinical trial model that was pioneered by the Pfizer REMOTE trial initiated in 2011.  The trial was the first randomized clinical trial to recruit patients using the web and to collect study data entirely using remote devices.  It was also the first application of econsent.  The REMOTE study proved the idea of a virtual trial was possible but it also revealed that targeting a population that is comfortable with the use of technology is critical.  REMOTE like most conventional trials failed to recruit their target population of study subjects.   However, Craig Lipset, Pfizer’s Head of Clinical Innovation told me and my partner Chris Gropp that they are currently running over two dozen studies using mobile and wearables and almost every clinical trial Pfizer is undertaking today includes planning for some form of mobile device even if they use a legacy model with a conventional clinical trial model.

To be clear, the technology is here and it is being utilized in different variations in trials today.  The true efficiency impact is often masked because the architecture of most clinical trials fail to integrate the systems seamlessly or do not take into consideration that success is dependent on reaching out to those who are comfortable with modern technology.

What is needed is visionary leadership from the pharma industry.

The virtual or in-home clinical trial or site-less clinical trial concept is remarkable.  By reassigning the management and support of a study from the site to the patient, the benefit is both a cost savings of up to 50% and increased resources for patient recruitment and engagement.  There is also the likely added bonus of reduced recruitment times and trial length, by as much as half.  Here are a few of the benefits that site-less clinical trials can offer:

Improved Recruitment and Patient Convenience: Larger pools of potential subjects are available as resources can be spent matching potential participants to studies using electronic medical records.  Most clinical trial sites are in major urban centers on the East Coast and West Coast as well as Chicago and Houston.  By breaking the geographic mold of trials, patients will not have to spend a day for each site visit.  The site-less clinical trial will democratize participation in the evaluation of the most promising medicines available.

Patient Centricity:  By shifting investment to smart phones, wearables, remote devices and electronic patient diaries, patients use devices they already are comfortable using.  Patients will report the truth of their condition to their smart phone instead of putting on a brave face to a doctor or nurse for fear of judgement.  Perhaps most importantly, more emphasis on the patient will result in the reaction, “I trust these people, they care about me.”

Improved Engagement and Compliance:  It is a hassle, especially when you are sick, to travel or fill out cumbersome consents and paper surveys or even just to the regional clinic site itself.  When participation is simple and can be done from home and smart phone compliance and questionnaires are intuitive, attrition decreases.  It is important to note that the virtual trial model is not appropriate for all therapeutic area such as oncology that require more physician oversight.

Reduced Risk:   When patients submit data electronically, the clinical outcome assessment takes place in real-time, allowing researchers to make protocol adjustments faster to reduce the risk to participants.

Regulatory Support:  Often times our industry puts off innovation and blames it on the FDA.  While the FDA cannot recommend innovation, they are openly encouraging solutions that offer larger data sets and more patient reported outcomes especially that which involves wearable data as FDA Commissioner Dr. Robert Califf pointed out in a March 2016 interview with US World and News Report.

How fast will virtual clinical trials reach widespread adoption by the pharmaceutical industry?

The history of diffusion of ideas to reality in the medical field is often twenty years or longer.  However, we live in the Connected Age. Airbnb and UBER were founded eight years ago and have had massive impact on their respective industries.  It is urgent to change the actual scheme of things in the clinical trial business. More efficient and more successful trials are possible.

Millions of lives and people’s quality of life are at stake. It is critical that the pioneers of the site-less CRO model connect with innovative biotech CEO’s to prove the benefit of trials and to show that are half the cost and time of conventional trials.

Please join us on December 12^th at MassBio in Cambridge, MA where CSM, Center Point and Trialogics will be hosting lunch and a two-hour session on Innovation in Clinical Supplies: The Cornerstone to the Next Generation of Patient Centric Clinical Research Forum, where we will explore in more detail direct-to-patient strategies and virtual clinical trial execution and benefits.

Note: Trialogics has developed an easy to integrate software that enables old and new business models to compress the time and cost of executing clinical trials.  Center Point Clinical Services  is combining Trialogic’s technology with its site-less CRO model to disrupt and improve the efficiency of drug testing.

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