Clinical Trial Execution in a Pandemic Age 

Pia Windelov, Director of Product Strategy and Customer Propositions for Lionbridge Life Sciences, spoke during a recent webinar about how the coronavirus pandemic has impacted clinical trials.

Here are a few highlights from her presentation. To hear the whole webinar, listen here.

How have regulatory agencies responded to the pandemic?

Since the onset of the pandemic, we've seen that the whole ecosystem around clinical trial execution has been impacted heavily. On the regulatory side, for instance, the FDA and the EMA, as well as several national level governments, have responded quickly by issuing emergency recommendations on the conduct and continuation of clinical trials during this crisis.

The agencies have opened up and provided more flexibility, for example, regarding the evaluation of protocol deviations. In addition, both the FDA and EMA have encouraged trial sponsors to consider alternative solutions to on-site visits such as phone interviews and video visits.

Where have clinical trials been most impacted?

All trial execution stages have been impacted more or less by COVID-19. For example, trial startup has been delayed or site activation put on hold for planned or ongoing clinical trials, while clinical trial authorizations for vaccines or therapies addressing COVID-19 have been expedited significantly, from months to days, to obtain regulatory green light for clinical trial conduct.

Looking at the reasons for disruptions, it is quite clear that patient enrollment is heavily impacted by COVID-19: 67 percent of trial enrollments having been suspended, while delays and slowing down of recruitment accounted for 18 and 15 percent, respectively.

During the recruitment and treatment phases, we've seen the highest impact since this is the period where sites are active and protocol procedures are carried out. Many trials have been redesigned or changed during these phases to replace or partly replace on-site visits with virtual trials.

What are the biggest opportunities and barriers for the current implementation of patient technologies were?

TransCelerate — an industry association for trial sponsors – conducted a series of surveys with approximately 600 subject matter experts consisting of pharma sponsors, sites and patients. The surveys focused on patient technologies and revealed a strong consensus around the value of these technologies, albeit with some barriers to be overcome.

For future opportunities, respondents identified improved data collection for patient reported outcomes, improved screening, consents, recruitment, and retention of patients, as well as reduced site burden.

As for the barriers in adopting these patient technologies, the survey identified costs, regulatory barriers, risk-averse company cultures, lack of process, infrastructure, technology, and expertise. And the burden on sites and patients did come up as barriers, although they were not considered major.

What's interesting about this survey, I think, is that the perceived benefit of patient technologies and virtual trials are focused very much on the patients and data collection, while the barriers are primarily of organizational, regulatory, and technical character. With patient recruitment and retention being the most cited challenges of trial execution, there should be a solid case for implementing more virtual elements into future trials.

What are remote or virtual trials? When are they best to use?

A virtual trial is defined by where and how the trial data are captured. Are they captured at a trial site, are they captured remotely, or as a hybrid of both? Are the data entered into a database by an intermediary, such as a study team member or a data entry clerk? Is it a capture directly from patients with some level of human interaction?

Because clinical trials vary a lot in complexity, it is hard to define the ideal remote model and there is really no one size fits all solution. I believe that the goal of virtual trials should be to aim for the low risk trials where there is a high return on virtual trial execution. There seems to be a sweet spot in phase 2 to 4 where trial virtual elements can be beneficial, but the most likely model we will see on the backside of the pandemic is probably more of a hybrid setup.

What should sponsors consider when deciding if a trial should on– or off-site? 

There are four aspects that trial sponsors should take into consideration when deciding the best mix of virtual and on-site trial activities on the technology side.

1. Consideration should be given to the platform used for the virtual communication. How are data collected? What does accessibility look like for patients and sites having to use the tools? What are the training needs? Are there any concerns around privacy?

2. On the content side, sponsors should ensure that content is fit for the patient technology, and for the purpose, of course. That means content is in the right form, frequency and volume.

3. Usability is an important element as well. This can be about navigation, convenience, user interfaces, and acceptance of technologies, which can vary across demographics.

4. And finally, language is a core component of any content directed a patients or users. When communicating to trial participants or laypeople, trial sponsors need to recognize that the audience is much more heterogeneous than in the medical community. Aspects such as health literacy and numeracy will become part of the success in remote patient communication and retention and this applies for all languages. So, the argument here is that successful virtual trial execution is per definition, patient-centric.

In addition to Windelov’s analysis of COVID-19’s impact on the clinical trial space, two other Lionbridge experts, Mark Aiello and Nataliya Volohov, and Medidata’s Paul O’Donohoe discussed patient reported outcomes,electronic clinical outcome assessments and the role of technology solutions in an increasingly virtual world.

Watch the full webinar here.