I recently had the pleasure of being invited to a panel discussion webinar run by the AVOCA Quality Consortium (to which MRN is a member) as part of its “Leading Change” program for members, discussing DCT, with sites and sponsors also represented on the panel. The topics are proposed by the members, and DCT was high on their list. As you would expect from an AQC audience, the focus of the discussion was heavily about risk. As part of the preparation, I was asked to think about “What does good look like?”. This sounded great – but was really hard to prepare for, as I was not sure what those in the audience were concerned about. “Good” could cover anything!
As the discussion developed, it became clear that the audience’s major concerns focused on two major areas – the dynamic between what is good for sites and what is good for sponsors, and the feeling of chaos the sites experienced with DCT during the pandemic. It seems that there is a backlash against DCT, which has been poorly implemented by some parties in the crisis forced upon us by the pandemic. In many ways, if trials were kept afloat during the last few years, then we can all cope with a bit of chaos, but the problem we all face now is, what is the right way to do this stuff when it can be controlled and managed effectively?
So, what does “good” look like? Drawing on over 16 years of DCT experience, here are my top 3 recommendations:
- That sponsors and CROs look for the experienced providers.
DCT appears easy to do, but as the sites expressed, many organizations have difficulty delivering.
This isn’t a sales pitch, but MRN is one of a very small number of companies – perhaps 6 –across the world who can co-ordinate global DCT services and have more than 5 years’ experience. Go back 10 years, and there are only 2 of us really. MRN (alone now – the others are all gone, swallowed up in global CROs) have been going for over 16 years, and after 75,000 + visits in the home across hundreds of projects, many of which (perhaps 50) were pivotal studies, MRN can now claim to have the majority (if not all) of the world class experts who have been in this field for 15 years or more (and we love to share our experience, if asked).
This type of expertise is essential, especially as the move into DCT is also a move into the more difficult drug delivery modalities, diseases and/or fragile patient populations.
- That there is continuity of care for patients.
Here is what we see as best practice in utilizing healthcare professionals in the community:
- Follow the core of GCP which states the staff conducting the trial must be deemed competent by means of qualification, experience, and training. As long as you are thoughtful about what assessments can be done in the home, a research trained healthcare professional can do many of these tasks.
- The PI should be allowed to choose or at least influence the choice of healthcare professional.
- The healthcare professional should visit the site prior to starting activities to build relationships with the site team they are joining and be trained in any specific elements the site feels is critical to their activities.
- The site staff and in-home healthcare professional should hand over to each other prior to each visit. An MRN Home Trial Support (HTS) healthcare professional typically gets a write up of the issues regarding the patient they are about to visit, then phones the site after the visit to update them. This is NOT trial data – but information about their general care. Anything related to the trial is recorded on the digital forms completed in the home. A report from our healthcare professional might go something like (and this is totally hypothetical) “Mary was a bit cold today making her veins hard to access. We were fine though, but I asked her to shut the windows before we come to make it easier. She was a bit unhappy her daughter had not been able to visit yesterday as her car broke down, although she is coming tomorrow apparently. She seemed a bit grumpy consequently, but everything went well in the study, and I left her feeling quite happy.”
These are the moments when escalation might take place. My fictitious Mary might have been “off her feet” or “more disorientated than normal”, which might lead our healthcare professional to ask for the patient to be seen by the site to check up on her, or to telephone her or initiate a telemed call, as well as clarification on what should be recorded on the trial documentation.
- Ensure there is support for the technology deployed.
Healthcare professionals in the field, require significant tech to deliver what is usually delivered in the hospital/research site. They are not ‘technologists’, so it is imperative that they have adequate back-up, and that the support is consistent and available no matter where in the world the study is being conducted. This means it is not always appropriate nor feasible to use the tech vendors help desks (too many different forms of tech and too variable levels of support).
MRN operates all countries with central clinical leaders and technical leaders (non-clinical). These people are on call during all visits to help the healthcare professional with any issues, from checking the address, troubleshooting the courier, operating the centrifuge, sorting the samples, and recording the data on the MRN iPads via our eSource system.
The local staff can also provide clinical support – if they have concerns over the patient and the site is not available, we advise on nursing care, help interpret the protocol, clarify definitions of AEs and SAEs etc and can report SAEs direct to the site and sponsor if required on their behalf.
If our country leads themselves have any questions – technological, clinical, logistical etc – they have access to Research Nurse Managers at our HQ sites around the world who can also provide more specific support and back up through normal communication channels, and these HQ staff also then have access to the help lines for the various technology and apps from the manufacturers and suppliers.
After describing this, I was rewarded with “So THAT is what good looks like!” Of course, that was lovely to hear, but most critically, I felt I had finally answered a difficult question.
The conversation however demanded more specifics, particularly around two main challenges perceived by the audience, which were the attitude of the PI to the continuity of patient care with in-home healthcare professionals and the support for the site staff in how to take part in DCT trials, focused mainly on the technology solutions which the sites are asked to use.