As clinical trials increasingly are conducted outside the US, Pharma and CROs face both opportunity and challenge especially in emerging markets.
Clinical trials have historically been carried out in relatively wealthy nations, however, in recent years Biopharma have turned their sights to so-called emerging regions, especially in Eastern European, Latin American and Asian countries (Nature: Trends in globalization of clinical trials).
According to The New England Journal of Medicine the 20 largest U.S. based drugmakers conduct about a third of their phase III clinical trials—typically the largest and most significant trial in the development of a drug—outside the country, and the number of trials in developing countries has grown 8% a year since 1997, according to Food and Drug Administration data.
There are many justifiable reasons for running clinical trials across multiple countries, or even only in sites that are not in the sponsor's/CRO's location (source: PLOS Medicine). The trial could be for a rare disease, such as dengue fever, and for these trials it is necessary to recruit many centers in diverse locations, each site perhaps recruiting just a few patients to avoid prolonging the duration of the trial and thereby the wait for lifesaving new interventions. However, cost reductions, is often cited as the primary driving force behind globalization, as for example, a clinical trial in India can cost one-tenth of the price that it would cost in the US (since clinical trials costs are largely driven by labor.)
Globalization is also attractive because it can help Pharma overcome regulatory barriers for drug approval in these countries in which the population size alone offers the promise of expanding markets, according to The New England Journal of Medicine.
Nevertheless, globalization of clinical trials is not without its challenges.
The life sciences industry has long recognized study startup as one of the worst performing areas in clinical trials—it is a bottleneck at the outset that slows drug development, leading to significant delays and costs. Is this acute problem now being exported?
Challenges related to time, distance, cultural difference, and language can impact site activation (see MD+DI article). Adding to this complexity are the country-specific regulatory requirements that must be adhered to for conducting clinical trials. In some countries all functions related to drug regulation are handled by a single agency, while in others state or provincial governments have some regulatory authority.
From an oversight perspective the complexity is self-evident as studies in on average have 82 sites per study (source: TTC, llc: Annual State of Clinical Development Costs)—How are all these country specific documents tracked? Where are we in the process? Where are the bottlenecks and inefficiencies? Where are these documents stored? And, who has access? Furthermore, ensuring that the most recent versions of these documents are used can be challenging, if not a daunting task especially if there are multiple versions and amendments, across multiple countries.
A study startup solution is the missing piece of the eClinical jigsaw that guides sponsors and CROs through clinical study startup – supporting country-specific document regulatory workflows – and serves as the repository for in-progress documents. The use of a study startup tool allows for the seamless sharing and visibility of documents and associated information in real-time—globally—facilitating handoffs. goBalto Activate, a study startup document and activity workflow solution, utilizes alerts, document collection, version control, status reporting, thereby eliminating the number of handoffs, errors and downtime events that typically occur throughout the start-up phase of clinical trials providing efficiencies in critical path management and SOP design.
Download our white paper Using eClinical systems to speed up clinical trials for a deep dive into the roles of eTMF, CTMS and study startup solutions in the clinical trials process.