Contributed by Joy Jurnack, RN, CCRC, FACRP
Our industry is heavily patient-centric, but how is the philosophy that this term implies put into practice? This question has been at the center of my thinking since I switched my perspective from on-site operations to commitment and solutions for patient-oriented research. Simply put, it means we cannot leave websites out of the discussion. I have some thoughts on this topic that I hope will lead to further in-depth discussions with the heads of the research sites and the coordinators who will implement the necessary processes:
Where does it start
We’re in the thick of it – too often, protocols are written before those of us who want to make them more patient-centered interrupt our suggestions for moving from conducting studies in a normal setting to conducting a decentralized environment. Going through protocol discrepancies and taking notes due to poorly designed protocols wastes everyone’s time – the protocols need to be developed flexibly to accommodate participants’ desire for some leeway in study visits.
Sponsors must take the additional steps to provide a thoughtful protocol change, with decentralization seen as an ideal situation to achieve where possible and provide study visit options that will satisfy our participants along the way.
It also starts with discussions between sponsors and locations. Developing hybrid approaches without using the know-how of the site only offers cumbersome protocols that are difficult to implement at the site level. Use of the website’s expertise will improve the sponsor-approved protocol and enable collaboration.
To do this, just try …
- Taking advantage of (in a positive way) clinical research professionals who work as advisors to sponsors and who know the patient population. These can be nurses who are either clinical or research oriented, providing practical advice with actionable solutions taking into account the specific needs of the potential patient population.
- Completion of a protocol to maximize flexibility within the assessment plan. Consider offering both trips to the study site and remote evaluations for each study visit. There might be events that require the Principal Investigator (PI) to be present, but in the meantime there could be a possibility that some of the study visits may be off-site to keep the participant busy and enrolled until the study is complete.
How does this happen at the site level?
Our research dictionary needs to be updated to move away from standard care terminology such as “home visits”. This is home research Visits and is to be seen as an extension of the activities at the research location. Interaction with the homeland 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 location, HRTs must be trained and delegated accordingly by the PI. While this is challenging, the involvement of professional research staff will go a long way in attracting websites. I am not suggesting that this is an easy task, yet it must be pursued; First, HRTs must have standardized good clinical practice knowledge from an accredited source and maintain it in accordance with guidelines from the US Food and Drug Administration. These companies can keep their own records and should already fully understand all of the documents required to conduct research. These files can be transmitted electronically in order to properly manage an electronic study master file.
HRTs should also be included in the site initiation visit to build trust quickly and be seen as an extension of the research team. Training a manager to train the people who go to the site does not allow the PI to delegate with the assurance that the study will be conducted in accordance with Form FDA 1572 (Statement of the Investigator). The oversight must be developed from the research site to ensure adequate oversight by the PI; These are regulatory expectations to be taken seriously.
HRTs should have access to the source documentation that the site uses to collect study data from the individual. Real-time access to study visit data, current concomitant medications, and ongoing adverse events enables investigators and study staff to monitor patient safety. The sharing of the actual source ensures continuity between the HRT and the site visits.
To do this, just try …
- Updated our vocabulary to properly define our research partners.
- Establishment of the research location for the success in the implementation of decentralization. Being patient centered also means engaging the site to ensure the safety and protection of the patient.
- Standardize through workshops and dialogue between vendors where and where all actors are in the decentralized test environment, and ensure appropriate training and delegation of authority. Engage PI and site personnel with HRTs through platforms that promote consistent source data collection, training on research activities, and support from PI oversight processes and communication.
If you’re like me, you know these two questions are the tip of the iceberg when it comes to the joint discussion required to truly move a research project from a fully on-site project to one that turns into a decentralized world can thrive. Identifying the most pressing issues that need to be addressed to increase the likelihood of a successful project begins with a thoughtful discussion – along with sharing ideas and implementing processes that will protect subjects throughout the life of a research project – and this will only expand our agility forward for the improvement of clinical research.
Joy Jurnack, RN, CCRC, FACRP, is a patient / subject research consultant who has ideas for implementing decentralized clinical trials at the site level.