The COVID-19 global pandemic is impacting every aspect of life as we know it. My own new reality is working from home with two young sons, shifting hour by hour between corporate executive and primary-school educator.
Even as business and personal lives intertwine, the pharmaceutical industry has not been distracted from its calling to defeat COVID-19. Organizations everywhere are rallying to find potential treatments and vaccines, while rethinking business models and supply chains to ensure all treatments, whether already in the market or still in development, continue to reach patients in need.
Our challenges are many. Some sponsors have put recruitment on hold in an attempt to mitigate the spread of COVID-19. Trials are experiencing delays in patient recruitment, data collection, and analysis due to patients being unable or unwilling to visit investigator sites. Yet a commitment to as much continuity as possible is evident across the industry, as we are all acutely aware of the patients that depend on trials for their daily care and future survival.
Digital clinical technologies: From “nice-to-have” to mission-critical
From countless conversations with sponsors of all sizes and therapeutic areas, we know that many of the digital solutions previously viewed as “nice to have” for clinical trial optimization are now proving to be vital to support sites. Clinical technologies are facilitating the necessary exchange of information and allowing the industry to continue its efforts to bring life-saving drugs to patients in need. Here are five areas where we have seen sponsors deploy digital clinical technologies to boost support to sites and enable innovative drug development to continue ― not only during the COVID-19 crisis but well into the future.
1. Prioritize payments to sites.
The pauses made in patient recruitment and patient visits for ongoing clinical trials due to COVID-19 are temporary, but work needs to continue for those patients already in a study. Unfortunately, some sites may not have the funds to pay staff while waiting for recruitment or studies to resume. According to the latest annual survey by the Society of Clinical Research Sites (SCRS), nearly 60% of sites have three months or less of cash on hand.1
With cashflow at sites so tight, it’s more important than ever to deploy technologies and expertise that enable payments to be made within 30 days. Just as importantly, sites need 24x7 access to information on activities they have been paid for and payments on the way. When working with sponsors that don’t have strong payment systems in place, sites often receive random checks in the mail without knowing which study or activity it is covering, and these checks are often too slow to arrive - from every quarter to every six months. The COVID-19 crisis is highlighting that sponsors must improve the timeliness and transparency of their payments process.
Additionally, we are seeing an influx of sites requesting to change to electronic payments. Sponsors now have the opportunity to eliminate the cumbersome processes and multiple levels of signoff required for paper checks – a positive step for today and the future.
2. Add remote consent capabilities to new and ongoing trials.
When global stay-at-home measures began, we encountered many situations where sponsors needed to quickly reassess their current procedures and adopt new solutions to keep trials moving. For instance, if a company required wet ink signatures on contracts and simultaneously prohibited contracts from being sent to employees’ home addresses, then business could not be conducted until at least one of those two requirements changed. Opting to accept digital signatures solves not only the immediate dilemma but also sets up for more modern, efficient practices when the pandemic ends.
The same applies to informed consent forms (ICFs), which are similar to contracts but are really intended to be much more. Investigators - and ultimately sponsors - need documentation that an actual conversation took place with the patient, and that the patient had sufficient time to consider the information and ask questions before the signature was obtained.
Intuitively, most sponsors understand the intrinsic value of electronic consent to improve areas such as patient recruitment and retention, regulatory compliance, and auditability; but making the change from paper-based to digital patient consent processes was often de-prioritized. Many cited regulatory requirements as a barrier. With protocols now needing to begin urgently or be amended quickly while face-to-face encounters are minimized, we are seeing a rapid turnaround in electronic consent’s prioritization by sponsors, as well as a corresponding shift in approach from regulatory agencies.
A key feature of IQVIA’s eConsent solution is remote consent capabilities. Remote consent enables the investigator to transmit a site-specific URL to a potential clinical trial participant - by text, email, or verbally. The patient can then access the URL on their own device – whether it’s a computer, tablet, or smart phone – as opposed to a paper document or a shared device at the site. The URL links to the ICF, and the investigator and patient can step through the document together, whether each of them is in their own home or together in the hospital. Once completed, the patient can provide a signature on the device or enter a unique code to indicate consent.
Many people associate electronic consent with high-end multimedia production. While adding video and animation enhances the educational experience for the patient, it is not necessary to obtain the benefits of remote consent, especially when starting up trials urgently. Similar to electronic payments and digital signatures, electronic and remote consent is sure to emerge from the pandemic as a standard clinical trial practice.
3. Assess and enhance site communication capabilities.
At IQVIA, we have a COVID-19 portal where all employees can turn for the latest information on the pandemic. The portal is updated continually and contains the very latest on policies and procedures, industry and internal data, travel guidelines, links to governmental sites, IQVIA’s own COVID-19 initiatives, and more. Even if some important updates are sent via corporate email, we know that we’ll be able to find that same information in the portal without digging through our inbox, unsure if we found the most recent message on a particular topic.
Similarly, investigator site portals with site-engagement functionality are purpose-built to provide a trusted communication channel for every trial. Each study portal creates a virtual community where news, announcements, frequently asked questions, study documents, friendly competitions, and leaderboards can be posted and shared in a central location.
Sponsors that have this strong communication channel already established for its trial networks are finding it to be an important advantage during the current crisis. When patient recruitment was put on hold for trials across therapeutic areas, sites needed clear, consistent, timely, and authoritative information on issues such as how to care for the patients that had already been randomized. Accordingly, we have seen an immense amount of activity through our site portals since the pandemic began, with sponsors using it as their official study-specific channel for COVID-19 communications and sharing new information every single day. Portal reporting enables them to measure the effectiveness of each communication based on the number of sites that have read them and can issue follow-up information to improve results as needed.
Perhaps most importantly, the ability to share information through the portal creates a sense of community that reminds sites they are not on their own. One of our clients, the vice president of a top five pharmaceutical sponsor, was inspired to write us to share that sentiment:
“Investigator site portals have been an essential tool for us in support of communications with investigators and site staff during COVID-19. This has enabled us to maintain a positive relationship with investigators as we need to quickly exchange information on this rapidly evolving situation.”
4. Make remote site initiation visits and virtual investigator meetings more productive.
A guiding principle for sponsors, investigators, and CROs since COVID-19 arrived is that patients and staff should not be going to sites unless it is absolutely necessary. Yet all stakeholders are motivated to start-up and participate in new trials, especially those testing COVID-19 treatments and vaccines. The situation has caused our digital-savvy clients to invent new use cases for the clinical technologies they’ve trusted many years to run their studies.
The inability to perform on-site visits and in-person meetings can be especially difficult for site training staff. Some of our clients are now using the learning management modules of the IQVIA Investigator Site Portal to add remote training to the agenda. Virtual SIVs and IMs become more feasible and productive by letting sites complete training either in advance or in real time with their CRA. Protocol and GCP trainings are assigned automatically based on role or task, and training records get updated with a complete real-time audit trail. Sites appreciate this organized, efficient and high-quality approach to training that demonstrates how much their time is valued. It also reduces administrative work for sponsors as it avoids the need to capture data in an Excel spreadsheet to be entered later into the learning management system.
5. Recalibrate studies and optimize the future.
Predicting the future has always been an interesting mix of science and art; and no one is sure how and when the current crisis will end. But our customers are working to adapt to the current situation and look ahead. Many are employing design and planning tools right now so they can be prepared for action as early as possible.
For instance, our investigator grant planning tool provides the ability to forecast costs with limited study information. Multiple COVID-19 indications are available in the system, allowing users to accurately plan and budget for various trial scenarios. Because this tool is vo to quickly cost out multiple possibilities, bring on rescue countries, and evaluate protocol amendments, it has been used to forecast fair market value (FMV) for more than 200 COVID-19 scenarios to date.
Now more than ever, we need to support the investigators that have been on the front lines, fighting COVID-19 in hospitals and seeing firsthand what works, and what doesn’t. As they bring forward proposals for investigator-initiated trials (IIT), IQVIA’s specialized tool to calculate FMV for IITs has already been deployed. Multiple COVID-19 indications are already available, helping sponsors with compliance when budgeting and reviewing IIT proposals.
Study optimization tools are also being leveraged by sponsors, our own IQVIA R&D services delivery team, and other CROs to reforecast enrollment due to the effect that COVID-19 has had on the screening and enrolling subjects in on-going studies. Rescue scenarios are being developed to model and compare possible strategies to help reduce these effects, aided by the ability to track and report on actual performance compared to planned targets at the study, region, country, and site level.
There’s no going back.
Navigating the new landscape forged by the COVID-19 pandemic has required every industry to adjust their business practices to ensure teams can interact and exchange vital day-to-day information. Corporations and institutions that equipped employees or students to work and learn at home and collaborate in teams with secure digital technologies before the pandemic began were at a distinct advantage over those that had to scramble to find and implement solutions after restrictions were enacted.
Is it possible that the same corporations and institutions will turn away from its newfound digital world once the pandemic is over? I for one believe not. While we will have an enhanced appreciation for face-to-face meetings with colleagues and clients when we return to offices, we will never give up the gains we made with the addition of virtual technologies to our work/life balance.
The same applies to digital technologies rapidly adopted and adapted to clinical trials during the pandemic. I recently participated in a roundtable discussion with executives from sponsors and sites, and it was universally agreed that because of COVID-19, all stakeholders involved in clinical development will make a move toward becoming more digitally enabled. Their mindset has been forced to change, and they can no longer be resistant to the technologies they were once skeptical about.
Wisely, the group agreed that the key decision criteria for deploying technology will be around investigator and site staff acceptance, adoption, and endorsement – often overlooked as sponsors focused on their own internal goals for efficiency without considering the burden to sites and patients. To support sites for the long haul, we need to improve the functionality, efficiency, and experience of trials beyond simply adding remote or virtual capabilities to isolated functions. Our aim should be to orchestrate clinical trials around the patient, site, and sponsor experiences, connecting activities and data in persona-driven journeys and enabling our industry to react and respond with immediacy to any future challenge.
I feel more confident than ever that sponsors and sites won’t turn back from the lessons learned and the gains made in our ability to run trials remotely, to give patients more options to participate, to create a community with sites, and to boost our support to investigators in every way we can. The mantra we hear around the world rings true for our industry: we are all in this together.
1 Society for Clinical Research Sites (SCRS) Annual Site Landscape Survey, presented by Casey Orvin, October 12, 2019.