Why pharma shouldn’t forget about sites in a post-COVID world

The pandemic forced massive changes to oncology sites to ensure patient safety and research continuity – but we must recalibrate and work with sites to understand the value proposition of the technologies and methodologies adopted, says Syneos Health’s Angela Hirst.

Formerly an oncology nurse and now director of Sites and Patient Services at Syneos Health’s Oncology Catalyst Site Network Program, Hirst saw first-hand the challenges sites faced when COVID hit, and the many innovative ways in which they adapted.

She says the US network sites reacted as most sites globally did, with anxiety and concern for their patients at the onset of COVID.

“The US healthcare system is complicated and is unlike state provided healthcare models in other countries. During the initial stages of the pandemic, patient onsite visits dropped due to trial cancellations and disruptions, leaving a financially devastating impact on many clinical research sites.

“Through our close relationships with our sites, it very quickly became clear that a significant concern, apart from the continuity of their patient’s care and treatment pathways, was financial stability. Annual surveys conducted by the Society for Clinical Research sites show that circa 60% of sites have three months or less cash flow.”

Syneos Health deployed an initiative to work together with pharma and sites to request any hold back payments to support financial stability.

“Approximately $15 million in back payments was released to sites. Today, SYNH continues to work with sites to target prompt site payments.”

Meanwhile, Hirst says the EU saw the hospital administrators adapt and flex their model by redeploying research teams in support of clinical areas to manage the surge of COVID-19 admissions. The impact of this was a sudden reduction in activity for the research units and their patients.

“Fortunately, we are witnessing a return to some normality,” says Hirst. “However, we must be conscious that patient footfall to sites continues to be reduced due to COVID-19 protocols and site staff resources.

“Restarting clinical trials placed on hold is complicated – 2020 was unprecedented, and we all still have much to learn in regard to starting scenario planning.”

In both regions, sites showed a great deal of innovation and agility to ensure the safety of their patients and staff.

Regulators were also agile and flexible, issuing timely guidance on IMP direct to patient, remote monitoring and telemedicine. Sites found alternative methods outside the traditional clinical trial visit to deliver study medication either by courier or coordinators, visiting patients at home, all whilst being socially distanced and with PPE techniques. In other cases, new technologies were introduced; sites adapted and implemented technology to ensure participants could continue to take part in clinical trials.

“As the world returns to some form of normal, we need to take this opportunity to learn what worked well and what we can improve upon,” Hirst says.

Decentralised sites

Although the increase in decentralising clinical trials has been essential to continue research over the pandemic, Hirst says these new processes have introduced an element of burden for sites to effectively support the increase in the number of systems required for all studies.

“Technology adoption in the industry has traditionally been quite gradual – for example IVRS introduced in the late 1980s took almost 20 years to reach 67% adoption. But the pandemic has accelerated everything – over the last 15 months almost 40% of sites began using eConsent, eSource and remote monitoring, which has resulted in significant challenges in terms of operational adjustment and system integration.

“A new approach to clinical research must always be to improve patient’s involvement, recruitment and timely completion of clinical trials by decentralising aspects of clinical trials, but we need to work together with sites to drive a patient centric approach in support of both the site and patient experience.

If the pharmaceutical industry is to continue progressing with drug development, and more importantly in a decentralised way in these post COVID times, a true understanding of how a research site conducts patient care alongside research activities is required, says Hirst.

“If we are decentralising elements of a clinical trial that would otherwise have taken place on-site, we need to first look independently at each stage of the trial and identify which elements could be replaced by virtual or home solutions, where applicable.

“Oncology decentralisation may be a little more complicated than other indications, for example.”

As a result of these fast paced innovative times, Syneos Health has launched a Decentralised Clinical Trial Site Advocacy Group, working with and listening to sites. “This will inform Syneos Health of our current and future DCT strategy to alleviate both site and patient burden,” Hirst says.

She adds that points to consider in the future will be:

Will decentralisation of these elements significantly reduce the burden on sites and patients, and therefore improve recruitment and retention?
Will reducing site visits accelerate timelines by allowing us to gather data faster, but be to the detriment of the patient experience, thus reducing retention?
Will changes to processes reduce workload for clinical trial sites, resulting in time and cost efficiencies, or will it increase and cause site staff to become demotivated?

Angela

Angela is currently a director, Site and Patients Services at Syneos Health, with senior oversight for the company’s Catalyst sites, Oncology in the EU and USA. During her time at Syneos Health, Angela has grown and developed the Oncology Network in the EU, whilst continuing to maintain carefully selected sites within the US. She finished her nursing career in 2005 as the lead breast cancer research nurse at the Royal Preston Hospital. Upon leaving the NHS, Angela was a site lead within IQVIA’s Access to Patients programme.

Syneos Health is the only fully integrated biopharmaceutical solutions organisation. The company, including a contract research organisation (CRO) and contract commercial organisation (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry-leading companies – INC Research and inVentiv Health – it brings together approximately 26,000 clinical and commercial minds to help its biopharmaceutical customers shorten the distance from lab to life. Learn more at syneoshealth.com.

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Why pharma shouldn’t forget about sites in a post-COVID world

“Restarting clinical trials placed on hold is complicated – 2020 was unprecedented, and we all still have much to learn in regard to starting scenario planning.”

Decentralised sites

“If we are decentralising elements of a clinical trial that would otherwise have taken place on-site, we need to first look independently at each stage of the trial and identify which elements could be replaced by virtual or home solutions, where applicable.

About the interviewee

About Syneos Health