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Evaluating the lessons learned about trial sites from COVID-19 to form new strategies and improve patient safety for the future.
The COVID-19 pandemic has been a lengthy, and uncomfortable pressure test for our global healthcare system. In the long term, we hope that 2020 will prove to be an inflection point for positive change, an urgent call to action to address the bottlenecks that have gotten in the way of a more efficient and effective way of improving human health. In the short-term, however, there have been more immediate and acute concerns about the ability of clinical development to continue in the face of widespread infection; how will patients continue participation when leaving home poses a significant risk?; what happens to patients who are relying on speedy development of life-changing, even life-saving, treatments?
As clinical trial sponsors faced unprecedented roadblocks, many quickly realized that speed and agility would be key if they were to steer their way through COVID-19 and ensure that research, discovery, and patient care were not completely obstructed. One critical area of focus was maintaining a strong site relationship strategy, and as countries move beyond the initial disruption of lockdowns, it is clear that the lessons learned in this area will be critical for ongoing efficiency and productivity in the “new normal.”
Without a doubt, the pandemic experience has exposed a number of shortcomings, some directly related to the current situation, but others more systemic. The subsequent assessment has left some sponsors reimagining what strong site relationship strategies in the future may (or rather, should) entail.
An effective and agile site strategy starts with viewing trial sites as valued partners throughout the entire clinical development process, not just a single stop on the way. By maintaining deep, ongoing relationships with sites and their patients, sponsors and their clinical research partners are able to quickly incorporate innovative approaches to adapting to obstacles at hand, like COVID-19, or increase efficiencies within the trial process.
It can be extremely valuable to categorize sites based on several partner factors to determine optimal ways and times to consider involving them in trials of interest. In a sense, this can position sponsors to assess their “go-to” site networks based on needs as they arise.
In these times, we see how strategically important it is for sponsors to maintain several diverse partnerships to maintain trial continuity for patients in need.
As some countries experience resurgences in COVID-19, some sites may need to close or make quick changes over the coming months. It is helpful for sponsors to adjust quickly by knowing what sites they can turn to and keep trials on track. In a long-term strategy, sponsors need to anticipate challenges in their pipeline programs and address them with foresight. Maintaining diverse partnerships can help match up trial needs with individual site capabilities, as part of a proactive strategy.
In traditional clinical development, investigators guide patient recruitment. During the initial months of the pandemic, when almost every aspect of clinical development was on hold, patient recruitment proved to be a tremendous concern for sponsors. With patient interest in trials increasing, it was essential to carve another path to reach them and connect them to trials.
As an example, to optimize patient recruitment, IQVIA uses a layered approach, efficiently utilizing our relationships with partner sites. First, recruitment starts with sites that have strong, comprehensive patient databases. These sites are highly qualified research sites. Because of the access to large numbers of potentially qualified patients onsite, staffing levels may be a limited concern in quickly contacting and qualifying patients within its systems.
To secure additional patients, we also rely on proprietary healthcare data assets and modeling algorithms using artificial intelligence and machine learning to create a direct-to-patient recruitment model. This approach allows sponsors to aid sites with recruitment by providing additional qualified patients for ongoing trials from our trial matching capabilities. By broadening the identification of patients beyond the site’s database, we are able to rapidly recruit participants and execute hyper-targeted multi-channel campaigns (e.g., social media, pharmacies, labs, patient communities, etc.) to also raise awareness of trials in their local markets. Delivering the right message at the right time is a key component of this model, which can be a productive way to engage patient populations quickly during downtimes and with limited resources.
To keep up with the potential volume of patients for ongoing trials, it is important to maintain the appropriate staffing levels when multiple protocols are enrolling at the same time. During the pandemic, maintaining appropriate staffing became a challenge for some sites. In these cases, qualified research staff were assigned to work at the direction of the principal investigator. Augmenting the staffing model played a key role in accelerating recruitment.
As sites reopened and targeted patients opted-in for participation, it was useful for sponsors to consider relying on the expertise of the global site network teams to provide experienced study support to reduce site burden and continue high-quality patient care throughout the trial.
Also, during the pandemic, routine patient visits with their providers decreased due to their own safety concerns and restricted access to critical patients only. The reduced patient volumes and corresponding billing reduction led many sites to furlough staff and/or reduce staff numbers and hours, creating more trial onboarding delays.
Another creative way IQVIA dealt with these delays was to re-engage furloughed site staff using sponsor funding, and temporarily engaging these staff through the global site network infrastructure to return and focus on specific protocol tasks.
This sponsor-funded approach allowed study sites to retain/bring back trained employees who know the appropriate trial protocols and steps to reduce onboarding time. By working with sites to augment staffing, sponsors know that trials remain on track despite roadblocks. If sites were bringing in new staff, these individuals would need to be trained on both research protocol and site-specific policies and practices, which would add time and cost to an already delayed trial process. As soon as the site research and patient care levels returned to normal rates or immediate protocol needs were fulfilled, staff would be able to return to regular activities, where funding would revert back to sites, not from sponsors.
The future is still uncertain, and while we don’t know exactly what a “post-COVID-19” world will look like, we do know that sponsors will need to consider trial site networks as partners to continue bringing important therapies to patients in need, both in the aftermath of this pandemic and in preparation for others in the future. Maintaining a thorough site relationship strategy for ongoing programs is part of a more holistic approach to trial design that is proving to be useful during the pandemic and may help shape the future of clinical development.
Mark Brown, Vice President, Global Patient and Site Solutions, IQVIA