The pandemic has left many clinical trial teams searching for ways to sustain their important work. Considering patients are leery of traveling to sites, and keeping staff safe is a top concern, pharmaceutical firms and their research partners seek solutions that enable trials to continue, so the drug development pipeline is not brought to a standstill.
Outsourcing-Pharma (OSP) recently spoke with Firma Clinical CEO Michael Woods (MW) about the widespread impact the COVID-19 pandemic has had on clinical trials, and how home health services and other solutions can fill the gap.
OSP: How has the use of home health services and decentralized trial technology evolved in recent years?
MW: An increasing number of procedures are being conducted in the home, as equipment that supports those procedures improves and becomes more mobile. Also, as telemedicine technology is improving and it becomes more widely used, you will see more dedicated research resources in the home setting, mirroring what we’re seeing in healthcare in general.
With participants at greater risk, such as the elderly, pediatrics, rare disease populations, there is an ease and safety advantage to have the research come to them.
OSP: Similarly, how have industry attitudes toward decentralized, virtual, and hybrid trials changed in recent years?
MW: Trials that adopt decentralized and patient-centric approaches like home health visits may be more successful. Patient-centric changes are happening quickly, as is the more rapid collection of data to support the development of a drug or device, and those who fail to adapt will suffer a competitive disadvantage.
OSP: Please talk about how the COVID-19 pandemic has impacted trials, including interruptions and stoppages, use of different data management technology, etc.
MW: COVID-19 challenges made the industry think differently about how to design trials with greater efficiency and access in order to enhance recruitment, retention and the entire trial experience.
- Data: Drug developers can shorten trial timelines and reach investigational product submission dates more quickly by deploying responsive study designs that capture accurate and meaningful data, accelerating clinical trial database builds and continually assessing data quality and analysis.
- Home health: Home health visits can lower risk and make it easier for a research subject to participate because there is no going into a doctor's office, clinic or hospital, where perceived risk is often far greater. A Firma home health visit occurs with personal protective equipment and everything possible to minimize risk. A nurse or phlebotomist communicates in advance with each research participant to ensure visit expectations are understood and to gain the risk perspective of the participant.
OSP: Has the pandemic brought to the surface any existing flaws in clinical trials?
MW: The pandemic has sped up the need to have data faster, and a highly functional electronic data capture (EDC) system is becoming a necessity. In a recent survey, more than three-quarters of industry professionals noted they have issues loading data into their EDC application, and most (66%) claimed that EDC system or integration issues are the primary reasons they are unable to load study data, especially since researchers collect data from many different sources, such as wearable technology, handheld devices, and social media platforms. Loading data from multiple applications can be challenging to complete in a timely manner, leading to greater delays and costs.
OSP: How has Firma worked to help clinical trial professionals adjust during this difficult situation?
MW: Firma tunes into what the research subject’s needs are and tailor our services to those needs.
OSP: How differently do you think the clinical trial landscape in, say, 2025 will look from how it had been in 2015?
MW: Decentralized trials will become the standard to ease the patient burden, reduce timelines and enhance trial success.
Firma Clinical will participate in DIA’s Virtual Exhibit Hall. The company will be setting up virtual appointments to discuss its home health and data services, designed to speed drug development clinical trials from study design through submission. For more information, visit the DIA 2020 event site.
