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6 things we learned from clinical trials in 2020

2020 has been a whirlwind year for clinical trials, with the challenges brought about by Covid-19 surfacing many long-standing pain points. Compromised trial data, either due to reduced site visits caused by travel restrictions, or as a result of reduced patient recruitment, extended timescales in drug development, questions around the reliability of the data collected, are just some of the issues faced.

However, the year has also brought about positive change, showing how the pharmaceutical sector is ready not only to adapt, but also to lead the way when it comes to innovation. New ways of working have been adapted, new processes have been implemented, new technologies have been embraced.

Here’s what we have learned from clinical trials in 2020.

1. It’s time to move from a site-centric to a patient-centric model

Patient safety remains an important — and powerful — factor in trial execution. Yet, until the pandemic outbreak, a prerequisite for most trials was that the patient would be able to be on-site. Clinical trials are often only available at academic medical centers and frequently require face-to-face visits, often requiring a sacrifice on the participant’s behalf, who would have to take time away from their families or work to be present.

However, following lockdowns and other restrictions imposed on movement to keep Covid-19 at bay, this was no longer possible; the site-centric model meant that most trials were ground to a halt. In fact, in a recent Medidata report, only 12% of respondents claimed that Covid-19 had no impact on continuing clinical trials or conducting new ones.

There has never been a better time for trials to move to a patient-centric model: one in which the patient feels more secure and comfortable to participate.

The use of technology can enhance enrollment, safety, and participation. Decentralized trials (DCTs) can be run despite limited face-to-face conduct, and patients are happy to be treated and monitored from their homes: the Center for Information and Study on Clinical Research Participation’s (CISCRP’s) 2019 Patient Experience Report found that 75% of patients say that collecting all study data from their own home is appealing and 73% like the idea of a hybrid trial.

100% on-site monitoring may no longer be necessary if patients can be monitored from their homes.

2. Trials need more diversity and inclusion

Diversity in clinical trials is crucial, as it can provide findings that can be applied to a broader population demographic, and also identify groups that might not respond to treatment as expected. In fact, in 2015, the FDA published “Drug Trial Snapshots” [1] which aimed at empowering consumers and healthcare providers with a transparent view of the demographic data from recently approved drugs. A recent example, that has brought this issue to the forefront, has been the race towards developing a vaccine for Covid-19, with the knowledge that the virus can have a disproportionate effect on people of color [2].

Research has identified the 5 main barriers to clinical trial participation, many of which spring from the site-centric model mentioned above [3]:

  1. Mistrust: lack of understanding the value, fear, stigma of participating, and communication style of investigator/staff
  2. Lack of comfort with the clinical trial process: mistrust of process, fear, family members’ opinions, and information
  3. Lack of information about clinical trials: fear and stigma of participating
  4. Time and resource constraints associated with clinical trial participation: financial burden, time commitment, transportation, and compensation and logistics
  5. Lack of clinical trial awareness: understanding the value and information (lack of awareness about the existence and importance of clinical trials, perhaps as a result of the location someone might live in)

Beyond the above, one must also consider the impact that travel and geographical location can have on patients with fatigue-inducing conditions, like a stage IV cancer patient. Groups that traditionally are less able to join trials, either because of financial or logistical burdens, can participate more easily in DCTs.

And if DCTs utilize wearable technology which the participants do not have to pay for themselves, then clinical trial solutions like Empatica’s can enable researchers to focus on the data, and participants to make virtually zero changes to their day-to-day.

This is further supported by recently published research (Rinah T. Yamamoto1, Nadeeka R. Dias1, Ammer Ishaque1, Kenneth G. Faulkner1 (ERT, Boston MA, USA)) on smartphone usage by trial participants. While only 31% of respondents owned a smartwatch, the overwhelming majority would be willing to use a wearable sensor in a clinical trial if it was provided.

3. Efficiencies in trial conduct and design are more crucial than ever

Small delays are manageable, but the long-term ‘jump-starting’ of trials can be catastrophic, yielding a lack of heterogeneity in the data collected, and subsequently leading to delays in drug and treatment development that could cause major financial and temporal setbacks, and ripple effects on those suffering from a range of health conditions:

In a recent Nature report on cancer clinical trials — which account for over one-third of the drug development pipeline [4] — nearly 60% of investigators reported that the COVID-19 pandemic had ‘moderate’ or ‘high’ impact on patient visits. In some cases, like at Yale University, these have been cut to “almost zero”[5]. Shutting down sites could have a critical impact on long-running and large clinical trials, as missed drug doses and inconsistent data collection can complicate the analysis of results. [6]

For trials that were almost completed, the main question was: to stop or not to stop early? For trials that were about to start, many are still on-hold, as recruitment remains a challenge.

Trial recruitment, communication with site staff, and data collection, are all inefficiencies that have once again come to the foreground [7], and according to experts, it is unlikely that trials will return back to full speed any time soon [8].

How trials should be restarted has to be approached with care, particularly to ensure the ongoing safety of patients. But the means are there, and the impressive pace with which the large Covid-19 vaccine trials have progressed can be a north star for how timelines can be reduced.

The rapid advancement of technology utilization could help drive efficiencies in the process. And so can collecting continuous data, which can unlock an understanding of patients’ physiology faster than snapshots of clinic metrics, especially as these clinics continue to be out of bounds.

4. COVID-19 has been a catalyst for change, and the industry is ready to embrace it

Researchers around the world were fast to respond, particularly regarding the acquisition of a better understanding of the virus itself, resulting in a monumental amount of studies published on Covid-19. And for trials relating to other conditions, telemedicine was the silver bullet. Nearly two-thirds of research sites monitored by WCG clinical, which collects information on 93% of industry-sponsored trials, have adopted telemedicine to conduct trials during Covid-19. Only roughly a quarter of sites did so before the pandemic. [9]

But researchers weren’t alone. Aligned to the urgency to put out quality, and potentially life-saving products, regulatory approvals by the FDA are speeding up, proving that there is a capacity for faster innovation adoption, and for a faster go-to-market for key products.

And the FDA, alongside other large bodies like the European Medicines Agency (EMA), also responded quickly and effectively to the threat that the pandemic posed to trials, by issuing new guidance on trial management during the pandemic. [10]

The biggest indicator of the oncoming change has been the below section in the recent publication of the US Senate Appropriations Package for the 2021 Fiscal Year, which clearly states that virtual trials via the use of connected sensors can increase patient convenience and operational efficiencies, and advises the FDA to advance the use of DCTs. [11]

Decentralized Trials.

The Committee is encouraged by the development of novel health digital technologies to facilitate the use of virtual decentralized clinical trials [DCTs], sometimes referred to as virtual trials, that would make it easier for patients to participate in trials, regardless of where they live. Through telemedicine and digital health technologies, (e.g. connected sensors and direct data capture tools), DCTs are conducted geographically near the patient. Direct contact with the patient is still maintained remotely, but, when appropriate, reducing or eliminating on-site visits has the potential to increase patient convenience and operational efficiencies in trial conduct. The Committee recommends that the FDA develop the necessary policy to advance the use of DCTs while still maintaining quality data necessary for FDA approval.

5. If data is king, devices are key

As of August 2020, clinicaltrials.gov shows that approximately 950 trials had used wearables in 2020, and according to Kaiser Associates and Intel, 70 percent of clinical trials will incorporate sensors by 2025. [12]

This comes as no surprise, since wearable research devices contain advanced sensors that can collect physiological data continuously, and with the utmost accuracy.

Clinical trials are often conducted across different centers, sometimes spanning multiple countries, even continents. The use of the same wearable device type across sites will help with data consistency regardless of the geographic location, especially if proper device usage training is provided. At-home data collection is also highly beneficial to researchers, since it results in numbers derived from real-life, that are consistent with the patients’ everyday activities.

Patients are also open to using wearable technology, particularly if the technology is designed in a way that keeps them engaged, for example through an app that displays some of their data, or the connection status of the sensors. In a recent study on epilepsy patients’ preference for wearables, the patients showed a significant preference for the wrist-worn devices, and the Empatica E4 device was preferred most often. [13]

But beyond the openness of patients, the data collected must also be reliable. There is abundant proof that wearable, medical-grade devices make clinical-quality data a possibility. In another recent study by VeraSci, preliminary data indicates “moderate correlations between remotely captured actigraphy and gait measures and established assessments of cognition and function, suggesting wearables can provide meaningful information regarding cognitive health and may ultimately contribute to continuous assessment of cognition and function in clinical trials.” [14]

6. We are learning to live with Covid-19, and technology is helping

In a survey conducted by Informa Pharma Intelligence, 76% of survey respondents noted that the pandemic sped their adoption of decentralized clinical trial methods. The same percentage (76%) reported at least some of their trials have already been decentralized, and 38% indicated more than half are decentralized. [15]

With patients unable to physically visit clinical trial sites, it is clear that the rate of adoption of DCTs has increased, and the expectation is that it will continue to do so.

It is quite likely that 2021 won’t signal a return to life as it was. But, if there is one thing we have learned in 2020, it is that humans are highly adaptable, and that, until its impact is mitigated, we must learn to live with Covid-19. This is true across all industries, and it is certainly true when it comes to clinical research. The conduct of trials has adapted to take into account social distancing, putting patient safety at its core, while the terms ‘decentralized’ and ‘hybrid trials’ have become permanent parts of our vocabulary.

Has this year been a turning point for clinical trials? We would like to think so. Though 2020 has brought a substantial amount of change to everyone’s lives, and some of this change was certainly not the most welcome, in the case of trials, change can be good. The decentralization of trials via digitization, through a platform that can enable patient recruitment and monitoring, enhanced by wearable devices that can collect data remotely and reliably, and paired with a more tolerant regulatory field, can pave the path towards faster and more robust results, paired with a vastly improved patient experience.

If you are exploring ways to decentralize your trials using Empatica’s wearable sensors and virtual platform, our team is here to help.

Sources

  1. Drug Trial Snapshots
  2. HEALTH NOTES: People of Color Suffer Disproportionate Impact of COVID-19 Pandemic
  3. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers
  4. Pharma R&D Annual Review 2019
  5. Coronavirus shuts down trials of drugs for multiple other diseases
  6. COVID-19 brings drug development to a halt
  7. It is unprecedented: trial management during the COVID-19 pandemic and beyond
  8. Covid-19 is forcing pharma to rethink clinical trials
  9. Clinical trials rebound after COVID-19 crash, but can enrollment gains continue?
  10. Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
  11. EXPLANATORY STATEMENT FOR AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS BILL, 2021
  12. AI and Wearables Bring New Data and Analytics to Clinical Trials
  13. Signal quality and patient experience with wearable devices for epilepsy management
  14. Real-time capture of gait and actigraphy using industry-grade wearable devices in older adults with and without subjective cognitive decline: Preliminary findings regarding feasibility, sensitivity and correlations with cognition
  15. Survey: COVID-19 the Tipping Point for Decentralized Clinical Trials

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