Accelerating innovation and its impact on patients and sites
The pharmaceutical industry has gained many valuable lessons from the impact of COVID-19 this year, especially how to continue clinical development both safely and with quality for patients in need. Navigating through difficult pandemic-related circumstances has accelerated the adoption of innovation in clinical research. Through a more holistic view, the industry is realising in real time how incorporating tech-enabled approaches and adaptive, agile strategies can provide a meaningful lifeline to trial continuity both as we deal with a pandemic and potentially for the long haul.
Prior to COVID-19, stakes were already high for the industry. Greater study complexities, cost restraints and changing regulatory requirements hampered how quickly much-needed therapies could be brought to patients. The pandemic placed a spotlight on the need for innovation across the full treatment development process. As we sought to maintain trial continuity by leveraging remote solutions, COVID-19 showed us how much more healthcare- and technology-savvy patients are than in the past. They need to be thought of as valued partners throughout the treatment development process.
When considering all the needs within clinical development that the pandemic brought to the forefront, it is also important to understand the impact on the availability of new treatments in the near term as some therapeutic areas were more capable (and successful) than others in continuing drug development, especially in the initial months of the pandemic.
Ultimately, clinical trial conduct will evolve to accommodate increased engagement by the patient and availability of remote solutions for all therapeutic areas.
Patient-centric clinical trials
Patients are increasingly interested in playing a more proactive role in managing their health. They research their conditions or symptoms online and come equipped to have a more meaningful discussion with their providers. In some cases, individuals voluntarily join clinical trial registries even before they are diagnosed with a disease.
With fewer than five percent of patients participating in trials, patient recruitment and engagement has been an ongoing challenge for the industry. However, recently, patients have been able to participate in trials remotely through decentralised solutions. As a result, patients do not always need to travel to trial sites, which in some cases can mean travelling to another city and taking time away from work and family. Reducing these burdens on the patient has helped to better engage them in the trial process. Patients stay involved in trials from their homes with the use of televisits and by sharing data with study teams via electronic diaries, wearables (eg, continuous glucose monitors, biosensors, smartphones) and other devices and apps. For the site team, collecting data remotely is a shift in how they fulfil their obligations to monitor patient safety and ensure data integrity.
To leverage patient interest further, trial sponsor and CRO (clinical research organisation) study teams can increase trial awareness and subsequently can reach more patients by incorporating direct-to-patient recruiting strategies alongside traditional methods. Looking beyond site databases and executing hyper-targeted multichannel campaigns through social media, patient communities, pharmacies and others can help engage patients quickly, especially in downtimes, as sites experienced early in the pandemic. In this model, patients are referred to an investigator near their location versus being identified by the investigator.
With a greater shift toward direct-to-patient engagement comes the need to consider how the commercial model will be impacted. As sites will need to monitor patient safety from data collected remotely versus on-site, they may require additional resources on-site. Also, as patients are referred to sites versus being identified by the site, the type of enrolment activities change. Investigator fees may need to be realigned to reflect these changes.
Remote trial execution
Digitisation has been accelerating and continues to in the time of COVID-19 as well as the deployment of remote capabilities throughout the trial cycle, from trial start-up to data monitoring and review. As the site is the hub of all trial activities, on-site visits will always be required; however, the remote aspect profoundly affects its processes. Clinical Research Assistants (CRAs) will spend less time at sites, given they can prepare for site visits remotely, including reviewing electronic medical records online. Additionally, site initiation and close out visits for sites experienced in clinical trial conduct can be done remotely. For site teams, this shift requires accommodations for shorter or less frequent on-site visits and more frequent check-ins via phone.
Furthermore, drug administration responsibilities may shift. Some investigational products can be delivered straight to the patient’s home. This will mean an increase in related televisits for providers to oversee treatment administration remotely or, in some cases, at-home support from trained nurses can be provided to assist in the administration. Leveraging home health nurse and phlebotomist services allows for vital sign administration, lab test sample collection, infusions or anything requiring a healthcare professional to safely be done at home. Again, site processes to review this information and monitor patient safety will evolve with these shifts.
Despite the range of potential remote services available to patients, it is possible sites may not be properly staffed or equipped to accommodate these changes, especially as some play catch-up after pandemic-related closures. In some cases, it can be useful for sponsors to consider bringing in global site network teams’ expertise to provide comprehensive and experienced study support to reduce site burden. Beyond COVID-19, as sites continue to face staffing and resource challenges, sponsor-funded support may be a solution to ensure site staff are able to provide high quality patient care.
During the initial months of the global pandemic, 64% of specialists reported a dip in the initiation of cancer treatment by patients and a 44% decline in patients seen per week. If not prioritised and quickly addressed, it could have been detrimental to the health of hundreds of thousands of cancer patients worldwide. Now, consider how clinical development for typically non-life-threatening indications, such as a dermatological condition, will fare. From our experience this year, COVID-19 and future roadblocks can create gaps in care and naturally place priorities on clinical development for potentially life-threatening conditions. Due to therapeutic prioritisation, treatments in the pipeline may be delayed or otherwise adversely impacted, ultimately impacting patients.
As we look ahead to 2021, it’s hard to know how COVID-19 will continue to influence clinical development. We do know that the industry is realising the potential for incorporating adaptive and agile strategies and technology-enabled solutions into trials to heighten patient-centricity, shorten timelines and improve data quality. In making these changes now and in the long term, it will be critical to factor in how patients, sites and other stakeholders are affected as they go about day-to-day study tasks.
Eran Gordon is senior vice president, Business Operations, Research & Development Solutions, at IQVIA