2021 trends in global clinical trial execution
The pharmaceutical industry, with the clinical trial process at its core, operates on a truly global scale, conducting studies to determine the safety and efficacy of therapies and vaccines, fundamental to the advancement of human health. For those involved in the facilitation of clinical trials, conducting studies across borders adds necessary texture and complexity to the process of bringing sophisticated and increasingly targeted new medicines to populations around the globe.
Over the past twenty years, the clinical research industry has experienced a surge in multinational clinical studies. Study sponsors benefit from stronger data and greater regulator confidence as a result of working with sites from around the globe to affirm that products are efficacious amongst various populations. For example, in a recently contracted study for which Greenphire is providing services, the sponsor is operating in 20 countries – from France to the Czech Republic, to the United Kingdom and Australia – countries with very different populations, regulations and healthcare systems. However, needs for systems and materials to be translated, regulation variance to be accommodated, negotiated rates to be localised and national health norms respected, inefficiency can inhibit speed of study execution, from site selection and initiation to patient recruitment and more.
The COVID-19 pandemic placed a spotlight on these and other issues inhibiting faster trial execution and elevated the urgency with which we confront and overcome these complexities. Regulators across the globe responded swiftly to the pandemic, permitting use of technologies and process modifications aimed at keeping existing clinical trials operational while at the same time clearing the path for aggressive new programmes to test coronavirus vaccines and therapeutics. Given the successes achieved over the past year, many believe that we have entered a new era of flexible care and that there is no going back to the manual processes of old.
Innovation in study start-up: improving clinical research budget and payment processes
In 2020, many clinical studies effectively paused enrolment while others launched at an unprecedented rate to bring new therapeutics to market. In this environment, it was particularly clear that the pace at which a study reaches first patient in (FPI) depends on the ability to rapidly navigate the complex financial administration of research operations.
Clinical trial contracting is an international exercise all on its own. To build budgets effectively, sponsors must have access to up-to-the-minute data to project costs by procedure, by therapeutic area and by country, plus the ability to contract with related parties in multiple languages and handling/processing a wide range of currencies through a simple interface. It’s important to get a budget done timely at the outset, but then ensuring it is managed efficiently, orderly and with full transparency becomes an essential and inevitable next step in today’s dynamic environment.
Yet, today’s budget development, negotiation and amendment workflows are largely manual exercises, resulting in frustration amongst sites and sponsors and costly delays in study start-up.
Connecting the dots from the initial steps of clinical trial budget development and negotiations to investigator grant payments is critical to ensuring that sponsors are effectively able to kickstart global studies, while adhering to timelines. A key to success is having solutions that enable centralised study control but offer a flexible and local service to accommodate the nuances of different geographies.
Patient centricity goes global
During the height of COVID-19, study sponsors sought the help of e-Clinical service providers to preserve patient engagement through technology. A mix of in-clinic and remote solutions helped sites keep patients enrolled whether they were looking for a safe means of transport to their research clinics or to maintain compliance with e-Diaries and data collection at home.
Whether it’s a global pandemic or not, varying standards in each country serves as a pain point and complicating factor for study sponsors looking to implement global patient convenience solutions. Translations, for instance, are essential for conducting trials internationally.
Unifying patient programmes such as reimbursements, payments and travel through an intuitive technology platform that offers an outstanding local service together with financial transparency is impossible when implementing disparate service providers around the globe.
It is critical to identify providers and solutions that can remove the burden of participating in and conducting trials from patients and sites – all while adhering to the global protocol requirements. Respondents to our recent Sponsor/CRO Survey indicated that improving the patient experience is a top priority, so we expect to see further growth and adoption of convenience solutions in 2021 and beyond.
Clinical trial regulation: finance and tax meet global payment execution
When it comes to regulation and clinical trials, many may think of documentation relating to the protection of study participants. However, clinical research operates at the intersection of numerous regulations – banking, tax, privacy and more which are governed by different bodies in various markets.
Focus on the effective facilitation of the business administration reveals the need for transparency. Study sponsors must be able to have clear records of global payments – who has been paid and why. For example, sponsors need to ensure that they aren’t overpaying research sites for work completed, and in order to do so, they need credible data to prove fair market value for trial activities as well as centralised platforms to both invoice and pay sites.
Tax compliance is another area of global complexity that consistently causes questions for clinical operations and finance professionals. For example, the understanding of, and impact of the Value Added Tax (VAT) and local equivalents, is necessary to navigate the complexities of multinational clinical trials. Depending on the tax laws of select countries, and contractual relationships between study sponsors, CROs and research sites, VAT exposure and recoupment risk can be mitigated – but proper documentation, data integrity, visibility and cash flow management are essential.
With market-specific regulations and governing bodies presenting complexity for trial execution, it’s crucial that study sponsors partner with providers that have proven fintech depth and who have applied that depth to the development of international solutions.
A nod to the future of clinical research
In clinical research, our unifying goal is to bring new treatments to market quickly, while ensuring we’re including appropriately broad and representative genetic diversity.
Recruitment and retention are global challenges. Removing the barriers to patient participation, namely providing solutions for travel, hybrid technology and reimbursements can help sponsors, CROs and sites improve patient engagement. It’s essential that the solutions are comprehensive and flexible to meet the demands of today’s global research environment.
As the clinical trial market continues to grow, the industry must think of how to connect the dots from the beginning of a trial to the end and unify the financial and administrative workflows for increased transparency, efficiency and regulatory adherence.
Multinational clinical trial execution depends on it.
Angela La Ronde is director, Relationship Management, at Greenphire