The Oracle Health Sciences survey is designed to pinpoint how organizations are approaching decentralized trials, and how such trials might impact the sponsors and vendors conducting such research. Once the survey is completed, the company will release an executive summary to those who request it.
Katherine Vandebelt, head of global clinical innovation at Oracle Health, told Outsourcing-Pharma the firm is using the phrase ‘decentralized’ rather than ‘virtual’ out of a desire for greater clarity.
“When you use the phrase ‘virtual study,’ people often think it’s using pre-existing data, rather than having actual patients involved,” she said. “That’s not the type of research we’re talking about, though it’s also important. We’re aligned with the preferred term, because it leads to a more accurate interpretation.”
Vandebelt said the survey is targeted toward professionals who are involved in actual clinical trial execution, such as sponsors, clinical research organizations (CROs), monitors and other key personnel. The answers, she said, will help pinpoint industry attitudes and perceptions around clinical trials, which have evolved in recent years.
“We’re going to be asking things around the benefits of having decentralized trial components, challenges, operational considerations, frequency, techniques and approaches,” she said, adding that the company and partner Avoca Group are spreading the word about the survey through social media posts, blogs and other means.
Vandebelt has been involved in the clinical research field for more than three decades, most of that time on the sponsor side of things. She said decentralized components have played a part in trials for about 20 years or more—over that time, trials have become more and more complicated.
“Things like the cost, protocol complexity, access to patients, qualifying healthcare people, attracting and retaining patients qualifying, attracted and retaining patients—they’re becoming increasingly more difficult,” she said.
“Decentralized components provide the ability to do two things—collect high-quality data, and make it way more feasible for people to participate in clinical trials,” she said. “The feasibility of using this technology has become easier, it’s more affordable, and incorporating these things into clinical trials is becoming more and more attractive.”
Vandebelt added that diving into decentralized trial technology has been a part of her work since she came on board at Oracle Health Sciences in February 2019.
“Decentralized trials can improve the quality of data, help to widen the pool of trial participants, improve patient convenience and retention,” she said. “We’re looking to continue assess the external market, to see the ecosystem, and see how it’s evolving over time.”
Additionally, technology solutions like the company’s Clinical One cloud-based data management platform can help facilitate easier, more effective execution of decentralized trials.
The survey, first issued March 9, will be circulated for approximately six weeks. Then, the organization plans to go over the results, compile the figures, and release the executive summary in May, with the full report ready in June. It can be found online here.