To understand the clinical trial landscape for the remainder of 2020 and beyond, it is essential to take into consideration the factors that incentivize R&D and account for the “new normal.”
Trial volume for COVID-19 therapeutics, vaccines, and diagnostics will continue to increase. Great strides have been made in creating diagnostic tests, but there is still a high margin of error associated with them, so we can expect to see more trials heading in that direction. We will also see a higher volume of mild-to-moderate treatment trials. Below we review tips for breaking into these types of studies.
Breaking into COVID-19 Trials: Treatments and Diagnostics
The types of studies you will find will include:
- inpatient or hospitalized trials, which entails patients with severe symptoms;
- outpatient trials, which entails patients with mild to moderate symptoms; and
- diagnostic or sample collection studies.
The specialties of investigators needed for these studies will include pulmonology, infectious diseases, critical care, or hospitalists for inpatient trials. Operating procedures will include SOPs specially developed for procedures relating to COVID-19, as well as patient and site staff safety.
We can also expect to see an increase in hybrid designs and new trials implementing them, especially for trials with vulnerable populations.
Hybrid Trials and Electronic Systems
A hybrid trial is the integration of a traditional, randomized control trial with more pragmatic design aspects based on collection of real-world data on patients. It’s a mix of traditional, on-site visits and non-traditional visits via home health services or telemedicine, for example. Hybrid-design clinical trials have been gaining momentum for years; COVID-19 has certainly highlighted the urgency with which the industry needs to embrace them. SCRS has provided a free, four-part virtual trial training capable program for which your institution can receive a certificate. It’s a good start to begin setting up for those trials.
Regarding electronic and paperless systems, we have been moving away from paper systems for about a decade. COVID-19 once again demonstrates the need to implement paperless systems. And it is a positive move for sites overall, because having electronic systems in place can help reduce site workload while increasing oversight on some key items, such as source documents, data collection, query management, and regulatory documents.
Contract & Budget Considerations
Understanding how the trial may be impacted by COVID-19 is key and whether this has been reflected in the contract and budget is key to negotiations and renegotiations. Our finance department has been proactively providing updated rationale, justification, and pricing based on a variety of elements. Requesting that holdbacks be removed is also important, as cash is crucial for your site’s day-to-day operations; sponsors have fortunately been granting this.
Additionally, sites should consider these additional pass-throughs:
- Increased prescreening
- Chart review
- Safety supplies for staff and patients
- IP packing and shipping (home health visits)
- Increased study-specific training