Almost two years into a global pandemic, the industry is recognizing and accepting that there is a “new normal” to both live and work within as we look ahead. We’re growing accustomed to navigating through the changing landscape due to COVID-19 as well as other complexities in clinical development. However, we know that COVID-19 is not going to be the first or last global roadblock to drug development. It is worth a retrospective look back at how the industry aimed to maintain trial continuity—what worked well as is, what needed improvements, and what we know is here to stay in terms of approaches and solutions that will help transform how much-needed treatments are developed and made available to patients globally.
 
Taking an aerial look at clinical development during the pandemic, the industry was able to pinpoint and prioritize what was necessary to power through site closures, regional shutdowns, concerns of patient travel and safety, and more, to come out on the other side and keep trials on track successfully. The valuable learnings we received in real-time can help determine future pathways to efficient, timely, and quality drug development.
 
Elevation of innovation
The foundation of the collective industry achievement to keep trials on track was to embrace and catalyze innovation in an unprecedented manner. Though rumblings of change were in flight, yet sub-scale, in this urgency, regulatory agencies expanded guidance around and voiced support of the use decentralized clinical trial (DCT) tools and technologies. Sponsors, clinical research organizations (CROs), government health agencies, and others in the wider healthcare ecosystem brought down competitive silos and elevated collaborative spirit to speed up decision-making, make quick adjustments, and set-up and execute clinical trials for COVID-19 vaccine research and other therapeutic areas. Most importantly, the pandemic was a tangible example of the impact clinical trials can have to meet our medical needs as a society, and in return, how crucial the patient voice is throughout the trial process.  
 
Patient-centric digitization
During the pandemic, we transitioned in real-time from drug development for patients to drug development with patients. Prior to COVID-19, the landscape was already growing with complexities, where sponsors and CRO partners knew changes to the traditional trial process was necessary. Sponsors and CRO partners with foresight of the need for agile, patient-centered trial approaches to stay efficient and successful made early investments into scalable tech-enabled solutions prior to the pandemic. COVID-19 helped accelerate use and optimization of these digital tools.
 
From growing acceptance and use of telehealth, connected devices, patient eDiaries, 24/7 online support from care teams, and remote monitoring, patients were able to safely start or continue trial participation from the comfort of their home and on their time —reducing logistical burdens that can impact trial engagement. Taking complimentary steps to digital tools, sponsors and CROs also launched or ramped up mobile research services, including at-home lab infusions, and treatment delivery.
 
In evaluating how integration of DCT tools fared during the pandemic, trials remained on track with patient safety and data quality in place, and in some cases, these solutions helped increase efficiencies to reduce projected timelines and cost despite pandemic roadblocks.
 
Looking ahead, sponsors and study teams will need to consider how virtual they can go, as not all studies can be 100% decentralized in design. In these cases, a hybrid approach incorporating DCT elements may be the optimal option. It is important for sponsors and CROs to ensure that DCT tools are purposeful, not creating additional burdens for patients and investigator teams.
 
Unconventional patient engagement
With patient interest in research at an all-time high during COVID-19 and many investigator teams understaffed and under resourced, sponsors anticipated a lost opportunity to engage new patients and significant delays in patient identification and onboarding, specifically as traditionally recruitment starts with site patient databases.
 
Using real-world data assets and modeling algorithms via artificial intelligence and machine learning (AI/ML), sponsors and CROs developed tailored, direct-to-patient (DTP) recruitment models. Widening patient identification beyond a site’s database, teams were able to execute targeted multi-channel campaigns, including pharmacies, laboratories, patient advocacies associations, and other healthcare partners, aiding sites with limited resources and staffing while expanding their patient pools, who may turn to them for ongoing care. Thinking-out-the-box, sponsors and CROs formed strategic partnerships with non-research organizations, digital social media companies, telecommunications, and technology companies—highlighting how collaboration for a greater cause can help ensure engaged patients are better matched to trials and nearby investigators.
 
It is through the strategic approach to broaden the net of outreach activities to quickly reach patients where they are that these DTP models also helped ensure trials were more accessible and inclusive of traditionally underrepresented and underserved populations. Improving diversity has been a long-standing priority (and challenge) for the industry, and the pandemic spotlighted patient barriers to trial participation.
 
Along with the increased use of AI/ML-based DTP recruitment models and DCT tools, the industry also took a hard look at understanding the need for trust in care among underserved communities. At IQVIA, we are working to build that trust among patients by supporting and developing sites with diverse study investigators with whom these patient populations can identify.
 
In ensuring the right patients are matched to the right trials for the long haul, sponsors will want to consider a proactive strategy at the earliest stages of trial planning to ensure they include all the right and scalable components for their efforts to be fruitful and meaningful to the patients they aim to serve. This includes potentially leveraging the breadth of real-world data available from growing patient registries that can, in some cases, can help to address specific research questions and follow disease progression and patient experiences and preferences.
 
Looking ahead
Though the global pandemic added another layer of challenges to the already complicated clinical development landscape, it was through the thoughtful (and rapid) collaborations and commitment across industry stakeholders that purposeful innovative solutions, whether developed, updated, or quickly implemented, helped us overcome the dominating global health challenge of our lifetimes.
 
Of course, in adjusting to post-pandemic clinical development, the hard work for the industry is not over. As we plan for future trial programs, it is vital to dive deeper into notable approaches and solutions utilized during the pandemic to better gauge how they can be adjusted and improved upon to better meet the needs of patients.