Two Questions and Five Suggestions Before You Begin Implementing Decentralized Trials

Joy Jurnack, RN, CCRC, FACRP, Patient/Subject Research Consultant

Contributed by Joy Jurnack, RN, CCRC, FACRP

Our industry is hyper-focused on patient centricity, but how is the philosophy implied by this term implemented in a practical way? This question has been front and center in my mind since switching my perspective from site operations to engagement and solutions for patient-centric research. Simply put, arriving at the answer means we cannot leave sites out of the discussion. I have some thoughts on the matter which I hope will lead to additional in-depth discussion with research site leaders and the coordinators who will implement the necessary processes:

Where does it start?

We’ve been coming in in the middle—protocols too often are already written before those of us who wish to make them more patient centric interrupt with our suggestions for switching from running the trials in brick-and-mortar settings to running them in a decentralized environment. Living through protocol deviations and notes to file due to poorly conceived protocols wastes everyone’s time—the protocols need to be developed with flexibility in mind to accommodate participants’ desire to have some leeway with study visits.

Sponsors must take the extra steps to provide a thoughtful protocol amendment with decentralization considered as an ideal situation to move toward whenever possible, providing options for study visits which satisfy our participants along the way.

It also starts with discussions between sponsors and sites. Developing hybrid approaches without tapping into the expertise of the site only provides awkward protocols which are difficult to implement at the site level. Tapping into the expertise of the site will enhance the sponsor-approved protocol and enable collaboration.

To accomplish this, why not try…

  • Taking advantage (in a good way) of clinical research professionals who work as consultants for sponsors and who know the patient population. These can be nurses who are either clinical or research specialized, offering practical advice with implementable solutions with consideration given to the specific needs of the potential subject population.
  • Finalizing a protocol to maximize flexibility within the schedule of assessments. Consider offering both trips to the study site and remote evaluations for each study visit. There could be events which require the principal investigator (PI) to be present, but in the meantime allowing some of the study visits to be done away from the site could provide a solution to keep the participant engaged and enrolled through completion of the study.

How does this happen at the site level?

Our research lexicon needs to be updated to move away from standard of care terminology such as “home health visits.” These are home research visits, and should be viewed as an extension of the activities at the research site. Interaction with the home research team (HRT) and the site team should start early, and developing a process to implement this relationship is essential.

As an extension of the research site, HRTs need to be trained and delegated appropriately by the PI. This does present a challenge, but engaging professional research personnel will go a long way in winning sites over. I am not suggesting this is an easy task, yet it needs to be strived for; for a start, HRTs must have standardized Good Clinical Practice skills from an accredited source and maintain them as per U.S. Food and Drug Administration policy. These companies can keep their own records and should already fully understand all the necessary documentation needed to perform research tasks. These files can be transmitted electronically to keep an electronic trial master file in compliance with the regulations.

HRTs should also be included in the site initiation visit to establish quick trust and be viewed as extensions of the research team. Training a manager to train the individuals going to the site does not allow for the PI to delegate with confidence that the study will be conducted in accordance with the Form FDA 1572 (Statement of the Investigator). Oversight must be developed from the research site to ensure appropriate oversight by the PI; these are regulatory expectations to be taken seriously.

HRTs should have access to the source documentation the site is using to collect study data from the subject. Access to study visit data, the current concomitant medications, and ongoing adverse events in real time enables the investigators and study staff to monitor the safety of the subject. Sharing the actual source provides continuity between the HRT and site visits.

To accomplish this, why not try…

  • Updating our vocabulary to properly define our research partners.
  • Setting up the research site for success when implementing decentralization. Being patient centric also means engaging the site to ensure subject safety and protection.
  • Standardize through workshops and dialogue between vendors who and where all the players are in the decentralized trial environment, and provide proper training and delegation of authority. Engage the PI and site staff with the HRTs through platforms which promote consistent source data collection, training on research activities, and support through process and communication of PI oversight.

If you’re like me, you know these two questions are the tip of the iceberg when it comes to the collaborative discussion needed to truly take a research project from being conducted entirely onsite to one that can thrive in a decentralized world. Identifying the urgent issues to be addressed to increase the likelihood of a successful project starts with thoughtful discussion—along with the exchange of ideas and implementation of processes which protect subjects through the life of a research project—and this will only expand our ability to move forward for the betterment of clinical research.

Joy Jurnack, RN, CCRC, FACRP, is a Patient/Subject Research Consultant who has ideas for how to implement decentralized clinical trials at the site level.