By Anthony Poynton, Senior Director, Program Delivery, Rare Disease & Pediatrics, Premier Research & Vicki Gashwiler, Executive Director, Specialty Programs, Premier Research
In the year since COVID-19 brought all normal activity to a halt, clinical trial professionals around the world have been forced to re-examine their strategies. What happens when neither patients nor clinical research associates can visit trial sites? How can data collection and data monitoring occur — and critically, how can researchers deliver clean, concise results that meet regulatory approval standards?
One simple solution: Maximize the usage of mobile health (mHealth) devices and remote monitoring to collect and manage data.
Over the past few years, researchers have begun using wireless technologies — from wearables and smartphone apps to home monitoring devices and patient-reported data — to link patients to clinical study teams. This methodology has been particularly prevalent in rare disease trials, where there is a critical need to reduce the patient burden.
These trials are often spread over broad geographic areas, which has forced participating patients to travel far and frequently. In recent years, researchers have found that eliminating such excessive travel can greatly increase both patient enrollment and compliance. Over the last year, when travel was challenging for everyone and “remote” was the watchword, those same techniques helped studies continue.
It turns out the change is popular: Both patients and clinicians have embraced the convenience of “going remote.” Regulatory guidance has also adapted to provide more flexibility in utilizing the mHealth strategies that keep patient visits as few and as virtual as possible. Consequently, understanding how to run clinical trials remotely and still deliver valid results has now gone from an interim step to the way we do business. We only see this trend increasing in the future.
Drawing from our experience both in rare disease trials and over the past year, we believe these three key strategies can help mitigate and manage risk while operating at a distance.
- Implement new data collection methods that place less burden on the patient, while remaining verifiable.
- Embrace mHealth for completely remote data collection
- Use local health centers, emergency medical technicians, or mobile nursing staff to collect patient data with no travel
- Strategically plan multi-day visits to minimize travel frequency
- Deploy technology to support remote review, minimizing the need for CRAs to be onsite.
- Have specialized central monitors evaluate pooled data across a large population
- Employ medical reviews to drill down to a specific patient and/or data point as necessary
- Use source data verification supplementally to examine specific suspect data, either remotely or onsite
- Clearly communicate changes to regulatory authorities and be careful to avoid compliance challenges.
- Detail shifts in protocol
- Clarify the steps that will be taken to collect data and verify safety and efficacy
- Update monitoring plans and standard operating procedures
Of course, there are other considerations. Sponsors must carefully select the technology that best delivers the data needed for a specific trial — as well as the technology that best collects, analyzes, and manages that data. They will need to adjust study budgets, shifting assets from travel, but in the short-term bolstering funds for both technology and the onsite support necessary to enable remote monitoring. They will also need to be careful that the shift to remote does not unnecessarily burden sites; this is new territory for sites, too, and will require many adjustments.
Flexibility is the watchword in the shift to more remote trials. There is no one-size-fits-all solution for a given trial — much less for all trials. Sponsors and investigative teams will need to adapt study design needs to accommodate this new reality. They will need to become fully engaged in the rapidly expanding rollout of mHealth technologies — and in the evolving regulations around the globe.
Those sponsors able to overcome these hurdles will be well-rewarded, as the promise of mHealth and remote trials is limitless. When properly implemented, these modalities will reduce the time and cost involved in data collection, streamline data verification while leaving a clear audit trail, improve trial efficiency and data accuracy, and greatly enhance patient participation and retention. Without patients, there can be no trials.