Survey: pandemic viewed as catalyst for positive change in trials

By Jenni Spinner

- Last updated on GMT

(Monty Rakusen/iStock via Getty Images Plus)
(Monty Rakusen/iStock via Getty Images Plus)

Related tags COVID-19 Coronavirus Oracle Clinical trials software Decentralized trials

According to a recent survey from Oracle Health Sciences, 97% of trial professionals say newly adopted approaches will stay in use as we move beyond COVID-19.

A new survey conducted on behalf of Oracle Health Sciences reveals perspectives and plans of clinical trial professionals regarding COVID-19’s impact on the industry. “Clinical Trial Management in a Post-Pandemic World” gathered data from July to September 2021 from 251 participants representing biopharmaceutical companies, medical device firms, and contract research organizations (CROs) involved in operating and managing trials. Most respondents hail from North America and Europe; the rest are situated in Japan, Asia Pacific, and other regions.

Outsourcing-Pharma connected with Oracle Health Sciences senior vice president and general manager Henry McNamara to learn more about the survey and what it might reveal about the clinical research field.

OSP: Could you please share some of the reasons why Oracle Health Sciences decided to tackle this survey?

HM: Last year, we surveyed the industry to assess the impact of the COVID-19 pandemic on clinical trial management and found the industry rapidly shifting to decentralized clinical trial methods, while balancing concerns around data quality and regulatory compliance. Now, a year later, we wanted to explore what clinical trial management looked like throughout the pandemic and what methods might remain post-pandemic.

As a provider of clinical trial software, it is important for us to understand what changes are happening in the industry and what those changes mean to clinical trial management so that our solutions always meet study teams’ needs today, and in the future.

OSP: Generally, what do the findings reveal about the flexibility and resourcefulness of the clinical trial industry?

Henry McNamara, senior VP and general manager, Oracle Health Sciences

HM: Simply put, for an industry that is so highly regulated, the survey revealed that those involved in clinical trials are more flexible and resourceful than we ever could have imagined. The forced adoption of fit-for-purpose, hybrid, and decentralized clinical trial models during the pandemic helped the industry better identify circumstances in which adaption was necessary and how to implement these approaches to improve clinical research.

It also showed, when faced with a difficult problem, the industry can pivot to help solve it in alternative ways. This is reflected in the results of this year’s survey as 84% of respondents implemented alternative approaches to continue their existing clinical trials and/or start new trials during the pandemic. And, of those respondents, 82% said these approaches had positively impacted their clinical trials overall.

Perhaps most importantly, 97% of companies said they expect to continue the use of these newly adopted methods in the post-pandemic world and give patients the option to choose how they participate in clinical trials.

OSP: Were there any surprises in the study findings, or responses that you might not have expected?

HM: It’s very encouraging to see such a large portion of the industry adopt new technology and approaches during the pandemic. It demonstrates that the “status quo or old way” of doing things has evolved, and the industry will be pushing forward from here. In our 2020 survey, one of the key findings revealed an industry that was concerned about change.

In last year’s survey, nearly half of respondents said that data reliability and quality (50%) and data collection (45%) were key concerns in adopting decentralized clinical trials. Now, having been forced to adopt decentralized clinical trial methods, it is both surprising – and encouraging – to see a large number of respondents (92%) in the survey that said they are equally or more confident in the data collected from these methods, compared to data collected via pre-pandemic methods.

Data quality is everything, so if people are confident in the data from these newly adopted methods – even more confident than they are in the old ways – then the new methods are likely to stay.

OSP: Do you have anything to add—about the survey, about continuing COVID-19 challenges, etc.?

HM: The pandemic accelerated the adoption of new approaches, technology, and models – many of which were being cautiously explored and piloted before – at scale. While this forced change was disruptive and surely worrisome, the impact of these changes, as we emerge from the pandemic, is overwhelmingly seen as positive.

Surely, as new approaches to engaging with patients and collecting data in clinical trials become mainstream, data diversity and volume will increase, but fortunately, the technology and software to support these changes in clinical research exists today and are designed to carry the industry into the future of clinical trials.

Moving forward, we’re excited to see how the industry continues to evolve and innovate to apply these newly adopted methods for both the benefit of clinical research and the patient. It will be really interesting to see where we are as an industry even one year from now, given how much learning has occurred during the pandemic.

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