Ben Thomas co-wrote this post with Chris Crabtree

4373_TrialInitiationStrategy_Blog-1Access COVID-19 resources

The COVID-19 outbreak has led to increased interest in the development of new vaccines and anti-viral therapies. Although this spike of attention on R&D should be welcomed, many members of the public remain unaware of the negative impact that COVID-19 is having on the development of therapies for other conditions. With more than three-quarters of trial sites reporting an impact of COVID-19, sponsors across the industry are pausing screening and enrollment in the interests of patient safety and data integrity. The implication is that COVID-19 will inevitably lead to a significant delay in getting new therapies to patients who need them.

It may come as no surprise, therefore, that sponsors of ongoing (and upcoming) clinical trials will need to think about a rapid yet empathetic trial reinitiation process. How can sponsors make sure that clinical trial sites maximize enrollment as quickly as possible while being mindful that many sites are recovering from one of the greatest stress tests in the history of modern healthcare provision?

As early affected markets start to see COVID-19 cases plateau, attention is turning to the gradual relaxation of lockdowns. Trial sponsors should, if they haven’t already, formulate their trial reinitiation strategy, which should be made up of four components:

1. Map out the steps of a site’s “reinitiation journey.” Although government restrictions may be lifted, sites still face several potential barriers: Do we have sufficient access to resources (personnel, equipment, etc.) to operate the trial protocol? Are we willing to restart given the burden of COVID-19 on our site to date? Are we able to effectively communicate and connect with patients given their fears around COVID-19? Sites will therefore sit somewhere on a reinitiation journey, like the example below:

4373_TrialInitiationStrategy_PPTGraphic-2 (1)

The journey from one step to another should be measured with predefined criteria (which may differ from study to study) to ensure that we can engage and enable sites with the right solutions at the right time.

2. Anticipate timing through predictive analytics and site outreach. Having a journey to set the strategy is not useful if sponsors have to play catch up when sites move along that journey. Predicting how long it might take a site to cross the reinitiation journey is fundamental to the planning process.

Predicting the relaxation of national- and regional-level restrictions can be tackled with predictive modelling of case rates, giving us directional insights into when sites may start to hang up the “open for business” signs.

However, this needs to be paired with strong data collection and analysis of site-level insights, particularly as sites head toward the second half of their reinitiation journeys. Site-facing teams, who may feel relatively sidelined currently, will play a key role in this process.

In addition, sponsors should look to leading indicators in their analytics for the patients who are currently enrolled at the site. Is site or patient activity picking up? For example, are patients completing their scheduled visits

3. Prepare an engagement strategy for each step of the way. The nature of the site reinitiation journey means that, inevitably, sites will have had different experiences depending on where in the journey they find themselves.

For each step in the journey, sponsors should be planning out what messages are given to sites, and what support and resources should be made available to them to enable their own reinitiation journeys. The approach taken will depend on the sponsor, but planning at the therapy-area level ensures that sites are not overwhelmed by study-specific communications.

Indeed, the engagement strategy needs to be empathetic to the substantial spike of communications awaiting a site that is starting to reinitiate, from the trials that are already being conducted to new trials with delayed start times. A winning strategy places a greater emphasis on differentiation and quality of messages rather than frequency.

While a site waits to make its first step on the journey, it’s important that sponsors are already maintaining contact. In a crisis, open, timely, clear and empathetic communication is key. Sites are looking to sponsors for guidance and support, and it’s important that sites receive this quickly or else they’ll find their information on a study from elsewhere.

The current limitations on patient enrollment will pass. Sites will, in time, turn their attention back to non-COVID-19 clinical trials. When they do, the demands on their time and the competition between studies will be greater than ever. How effective sponsors are with their trial reinitiation strategies will determine how successful they are in completing enrollment and getting much-needed innovative medicines to patients.

For more ZS insights on the impact of COVID-19, visit zs.com/COVID19.

 


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Topics: clinical trial design, clinical trials, covid-19, clinical trial execution, covid-19 clinical trials, clinical trial initiation