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Transforming Clinical Trials

By Study NeedBy Study Role

August 12, 2020

Technology Can Be a “Guardian Angel” on the Shoulder of Investigative Site Staff

A perspective from drug development expert Dr. Ellen Vigdorth

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      Dr. Ellen Vigdorth

      Infectious Disease Epidemiology at University of Cincinnati College of Medicine


    Guest blogger Dr. Ellen Vigdorth shares her perspective on how technology is a key enabler to avoid a “multiplier effect” of errors for faster, safer and more efficient infectious disease clinical trials.

    In today’s rapidly changing environment, speed is everything in infectious disease trials. For the best probability of success, investigative site staff need immediate answers and real-time updates. But let’s face it, we don’t make it easy for site staff today.

    Depending on the trial, you may have multiple protocol amendments, even country level amendments, so it can be challenging for study coordinators and physicians to stay current on the latest study guidance. You may need to know the status of a cohort so you can control screening to cohort closure.

    Avoiding the "Multiplier Effect"

    In vaccine trials, the consequences of errors are quickly multiplied. The last thing you want is to lose an entire cohort or day of enrollment due to replicated errors. I call this the “multiplier effect.” For example, if we didn’t take specimens appropriately or complete assessments correctly, this would have a knock-on effect and every specimen/assessment could be lost for efficacy evaluation that day.

    Investigators and study coordinators want to be compliant with the protocol and avoid deviations because of potential impacts to patient safety and the study results. The issue is that there’s a real need to make quick decisions, especially when it comes to vaccine trials, because time is of the essence. The way trials are conducted today, it can be hard work for site staff to be both accurate and efficient.

    For this reason, vaccine trials need to be more collaborative and immediately interactive than perhaps any other type of trial. Best practice sharing among different sites, means study coordinators can learn from their peers about what is working and what’s not so that they can adapt at their own facility.

    But today, collaboration and communication are time consuming. For example, I was involved in trials where study coordinators and CRAs had three calls a day – morning, midday and evening. The morning briefing would provide any adjustments or updates to safety information. The midday briefing would be a midpoint check on enrollment. The evening briefing was a summary of the day.

    Let’s say there is a safety hold that happens after the morning briefing. That notification needs to go out immediately – not held for the next briefing call. And it certainly isn’t going to help the staff if they get a fax or an email about it. As we typically enroll large numbers of subjects each day in vaccine trials, we need to be aggressive in management and communication. Real-time decisions and the communication of information are critical for patient safety.

    The Opportunity for Technology

    Anything that makes it easier for the site to be supported in a timely manner and reduces friction that inhibits enrollment and performance would be hugely appreciated. Technology needs to be nimble, flexible and readily adopted to be successful.

    I see the opportunity for technology to act as a “guardian angel” on the shoulder of research staff, to coach them with the right answers. Should dosing be delayed, deferred to later or terminated if the subject/patient has certain symptoms? What are acceptable concomitant medications when considering eligibility? If study subjects come in late in the afternoon, do they get both the morning and afternoon dose, p.m. dose or a.m. dose?

    The point is that the protocol and study advice should be readily available for all investigative site staff in a simple, straightforward manner. Time is wasted if they have to hunt through text messages, faxes, emails and voicemails. If the protocol and essential guidance are simply and immediately available on demand, I believe the right subjects/patients can be enrolled faster, there would be fewer procedural errors, and physicians can quickly identify the best course of action based on symptoms.

    Sponsors and CROs will see other benefits in providing more of a self-service model for investigative staff. Take for example the army of people working 12 hour shifts to keep pace with the volume of site inquiries. Or the go-between time and effort it takes for a CRA to get an answer from a medical expert, instead of just providing a direct and quick line of communication in the first place. It also means that sponsors and CROs can show the regulators that they took the appropriate corrective action during the trial.

    If you think about the “tunnel effect” in Infectious Disease trials, staff are frequently clad in personal protective equipment (PPE) in the patient’s environment. It’s hardly the case that they will get out of their gear to refer to the regulatory binder or log on to a desktop computer to find an answer.

    They already have their smartphones with them as a resource, so why couldn’t they use it to access the protocol and other study guidance? They don’t have the time to call their CRA – and for younger medical and nursing staff, it is a natural instinct to take out their phones to find an answer. This would completely change the game for fast moving clinical trials.

    Photo of Ellen Vigdorth

    Dr. Ellen Vigdorth

    Infectious Disease Epidemiology at University of Cincinnati College of Medicine


    Dr. Ellen Vigdorth has more than 25 years of drug development experience. She has led clinical development programs across a range of therapeutic indications. Ellen spent more than 20 years in various roles at IQVIA (formerly Quintiles). Initially trained as a microbiologist, she holds a PhD in infectious disease epidemiology from the University of Cincinnati College of Medicine.