Disrupted clinical trials to have knock-on effects on R&D, experts warn

01 May 2020 --- Consumers are increasingly wary of verifying the efficacy of products, meaning scientific backing has never been more critical. However, the rise of COVID-19 could throw a wrench in many companies’ plans for clinical trials as lockdowns and social distancing restrictions continue around the globe. NutritionInsight examines to what extent R&D may be affected and how long these impacts may last, as researchers push for trials to continue.

“Clinical trials drive development and branded ingredients that sponsor clinical trials are seen as a value-add. Furthermore, since new product developments are often based on clinical trials, most projects will probably not be able to commence until 2021 and beyond. This is a significant setback as we hoped to see R&D start in 2020 based on the results of these clinical studies,” David Tetzlaf, Director of Marketing at Evolva, tells NutritionInsight.

In a viewpoint paper published in JAMA, Dr. Mary McDermott and Dr. Anne Newman detail that randomized trials provide the highest-quality evidence for identifying therapies to help people attain longer and healthier lives. As of March 2020, ClinicalTrials.gov listed 262,366 ongoing randomized clinical trials, including 146,420 trials studying drug or biologic interventions.

However, now The Institutes of Health has advised investigators to consult with their institutional review boards and institutions about potential measures to protect participants and research staff. These have ranged from a mandatory suspension of research involving human participants (except when this increases risk to participants) to relying on principal investigator discretion.

Minimizing disruption
Dr. McDermott and Dr. Newman are calling for clinical trials to continue as much as is safely possible, noting that the trials require years to design, fund, conduct and complete, but are essential for improving health and preventing disability.

“The effects of the coronavirus pandemic on randomized trials hopefully will be short-lived, relative to the long-term benefits of these trials to millions of people who will continue to live with debilitating medical diseases after the crisis ends. To maximize public health benefits, creativity and persistence are required, especially during these unprecedented and uncertain times,” they state.

The researchers flag a range of solutions to minimize disruption and preserve the integrity of ongoing randomized clinical trials while ensuring participant health and safety. These include clear communication from research staff to protect against dropout and prioritizing primary outcomes and those that can be collected remotely.

They also note that an intervention could be extended by a few months so that follow-up testing can be carried out while the participant is still receiving the intervention once isolation restrictions are lifted. Meanwhile, virtual interventions offer additional alternatives. For example, if the original study involved exercise sessions at a gym, this could be converted to a home-based session with remote monitoring.

Clinical trial delays
Weighing in on how COVID-19 has affected Evolva’s trials, Tetzlaf details that the company had two key clinical trials planned for Veri-te resveratrol in 2020 that have been delayed to Q3 or Q4. One is a skin health study in France but can’t proceed in summer, even if restrictions lessen because it is not the best time of year to evaluate skin health while the sun is at its peak.

The company is also sponsoring an important clinical study where the principal investigators were initiating the recruitment of participants. In this case, there will be a considered delay in the initiation of the study as it is not possible to keep the social distancing rule as several checks would be performed in the participants, as well as involving many research personnel.

“What we can see is that the extension of delays will vary according to the type of studies and mainly the needs for interaction with participants as for physical examinations. We also can add that these restrictions put a burden on the students and staff facing unemployment until the government reopens,” he explains.

Evolva has had difficulty communication the findings of its clinical studies as trades shows and in-person meetings are cancelled. Adapting to a “new reality”
Outside of R&D, Tetzlaf flags that COVID-19 is also posing a challenge in terms of trade shows and meeting cancellations. He highlights that it has been difficult to communicate the findings of the company’s two long-term clinical studies that were finalized in 2019 and are being published this year. Last month, the first findings of the Resveratrol Supporting Healthy Aging in Women (RESHAW) clinical study revealed that daily supplementation with Evolva’s Veri-te resveratrol ingredient can improve cognitive performance and reduce the decline in cerebrovascular responsiveness (CVR) of postmenopausal women.

Tetzlaf predicts that in the long-term, the company will bounce back quickly as it moves forward on the clinical trials that are in the queue for 2020, once allowed by local governments. “While this setback will certainly have a delay on NPDbased on these specific clinical studies, we believe there is currently a significant increase in NPD for immune health products,” he adds.

Immunity has been a major topic throughout the pandemic, with Probi reporting a clear increase in interest in its immunity products. Meanwhile, Virun Nutra-Biosciences told NutritionInsight that now is a “great time to start a new brand in the supplement space.” This coincides with a study review calling for supplementation to be included as part of public health recommendations fighting against COVID-19.

“For the long-term, while immune health will still be a hot topic, we are hoping companies can ramp up development quickly upon the completion of new studies that focus on other areas of health as well,” says Tetzlaf. Marcia da Silva Pinto, Technical Sales & Customer Support Manager, adds: “As we see in many parts of our lives, we are adapting to a new reality, so it is expected that companies and R&D departments will find ways to keep up with innovation.”

By Katherine Durrell

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