Innovative and personalized treatments are transforming the face of modern medicine. As patient populations become more targeted, clinical trial organizers are using strict criteria to precisely capture therapeutic effects in these populations. Successful study planning in Europe and Asia requires operational expertise, market understanding, contingency planning, and the right partners.
The global pandemic in 2020 brought many industrial sectors to a standstill. Although a large number of clinical trials around the world were affected by the global health emergency, biotech companies made dedicated efforts to ensure clinical trials continued as seamlessly as possible. In fact – Covid-19 aside – the number of clinical trials has steadily increased from 15,000 new studies commissioned in 2015 to 22,000 in 2020.
With these rising numbers, traditional research sites, such as those in the US, face increasing competition in the clinical trial space: Emerging economies are becoming hotbeds of innovation, pushing the biotech sector to explore new locations for conducting clinical studies.
Unique opportunities: clinical trials in Asia and Europe
“A large number of clinical trials today require a multi-country as well as a multi-region approach,” explained Katarzyna Moscicka, Head of Feasibility, at the Swiss global contract research organization PSI CRO.
“Clinical trial numbers in Asia and Europe are increasing every month and biotech and pharma companies must keep track of this change and do all it takes to stay in the game. This requires on-the-ground expertise to be able to conduct trials that meet regulatory requirements.”
Personalized medicine has become a popular treatment approach in Western Europe, and experts anticipate a steady increase in the overall number of these trials. To meet enrollment goals for this increased demand, trials are expanding to Central and Eastern Europe.
However, the number of local next-generation sequencing labs in Central and Eastern Europe is limited in comparison to Western Europe. But well-equipped sites and experienced investigators can offset this difference by providing a large pool of patients for enrolment.
By involving institutions with the right capability in this region, trials in Central and Eastern Europe today can even require fewer sites to meet the same enrollment goals as they would in Western Europe.
Handling these opportunities while avoiding potential pitfalls can be tricky because the key challenges in clinical trial designs tend to be interdependent, Moscicka cautioned. “Within specific indications – for example, in the inflammatory bowel disease area – in parallel to the growing number of studies, we have also seen an increase in duration of individual trials. This, in turn, has resulted in a higher competition to procure sites for clinical studies.”
Planning ahead: feasibility assessments
A feasibility assessment, regarded as key by clinical trial planning experts, looks to anticipate the potential challenges in trial planning. A well-structured assessment increases the chances of timely patient enrollment, helps adhere to the budget, and ensures reliability of the trial results.
“The goal of strategic feasibility is to identify key study elements that negatively or positively impact a trial’s operational capabilities,” explained Moscicka. “Strategic feasibility defines a series of study specifications that realistically position an investigational product for success amidst the competitive landscape at a site, country, and region.”
The critical step that often determines the timeline of a trial is patient enrolment. Therefore, patient availability must be rigorously validated at the country, regional, and site level in order to achieve on-time patient enrolment. Accurately identifying and qualifying trial sites as well as recruiting target patients with tailored engagement strategies calls for proven local expertise.
A reputation for on-time and quality delivery
PSI has helped many of its biotech sponsors in executing complex clinical trials in previously unchartered territories. “We pride ourselves on enrolling 90% of our trials on or ahead of time. Even during the Covid-19 pandemic this year, we achieved 75%,” described Moscicka.
One of the main drivers of this success rate is PSI’s focus on specialized therapeutic indications. Its core therapeutic focus areas are oncology, hematology, infectious diseases, inflammatory bowel disease, multiple sclerosis, and rare diseases. Over 25 years, PSI has built well-established networks within these therapeutic specialties by fostering strategic relationships with site staff and investigators.
“Our hands-on interaction with site partners helps us identify top ranking countries and sites for specific indications. This data coupled with our experience aids our decision-making. By designing contingency plans at the feasibility testing stage and by relying on continuous learning, we ensure our projects are delivered on time,” said Moscicka.
To leverage insights from the abundance of data that clinical trials generate, PSI has cultivated internal tools and platforms for centralized information repository, analysis, and processing. Also intrinsic to PSI’s methodology are tailored support services that help align expectations between investigators and patients.
“We focus not only on recruiting patients, but also on proactively developing solutions to counter potential barriers to patient enrolment, compliance, and retention,” explained Moscicka.
“To maximize patient convenience and site communication, we can provide strategic guidance for managing a suite of customizable services, such as at-home drug dispensing via home nursing services, direct-to-patient drug shipments, E-consent, and telemedicine support.”
The key to continued trial success is being equipped with the right combination of indication-specific knowledge, on-ground contacts as well as an agile and attentive attitude. With the ongoing Covid-19 pandemic only exacerbating the many challenges in clinical trial design and set-up, working with an experienced CRO partner can be of great importance.
To hear more from Katarzyna Moscicka on the impact of a comprehensive feasibility strategy and how it drives successful trial enrollment, check out this recent, on-demand webinar. To partner with PSI for successful clinical trials in Asia and Europe, visit the company’s website.
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