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Discovery & Development Clinical Trials, COVID-19, Supply Chain, Standards & Regulation

The Global Stage

From increased demand for biologic treatments to the urgent need for COVID-19 vaccines, the clinical trials industry has been challenged to develop trials more quickly than ever. To meet these demands, sponsors and CROs have been expanding capacity by conducting clinical trials in emerging geographies.

In the clinical trials market, “emerging geographies” typically refers to the BRICS block (Brazil, Russia, India, China and South Africa). Recently, the Middle East has also been an expanding geography for clinical trials. There are three primary reasons to consider conducting clinical trials in these areas: i) large patient populations that allows faster recruitment and offers broader diversity, ii) increasing prevalence of chronic diseases, such as diabetes and cardiovascular disease (helpful for trials for drugs targeting these areas), and iii) more cost-efficient trials than those in Western countries – especially when it comes to trials for comparator drugs, which are less expensive to source in emerging regions.

To benefit from conducting clinical trials in these regions, there are four key challenges that need to be considered.

I) Regulation. Over the last five years, regulations in BRICS nations have advanced to provide sponsors and CROs with greater transparency; however, the regulatory process can be lengthy and entail extensive bureaucracy that varies between countries. It’s essential for sponsors and CROs to understand regulations within all relevant jurisdictions to avoid inadvertent violations, which could add cost and time, and potentially impact local community trust. Partnering with in-country investigators, particularly during protocol development and the submission process, can help avoid these challenges. Whether working with a local CRO or an international CRO with wide expertise in conducting trials in a specific region, specialized expertise can help trials run smoothly and stay on track.

As the demand for clinical trials grows, emerging regions are increasingly valued partners.

II) Culture. Many emerging regions have a legacy of traditional medicine, making it difficult to recruit community members to participate in studies for drug development. In addition, some communities have had prior experiences with clinical trials that led to lingering mistrust, which can make it difficult to recruit patients for new studies. It is important to engage with communities in these regions to build trust. Establishing or partnering with community engagement boards (CEBs) – comprised of multiple levels of local leadership, such as health care officials or rural leaders, sponsors, and CROs – can facilitate recruitment and bridge potential trust gaps.

III) Staffing. Sponsors and CROs often rely on local people to conduct trials, but ensuring that staff are properly trained in good clinical and laboratory practices may not be straightforward. A second critical factor is that staff turnover in emerging regions tends to be higher than in Western countries. These challenges are common, so sponsors and CROs should have staffing and training plans in place before the clinical trial begins. In addition to comprehensive training programs, it is essential to ensure staff continuity with initiatives like “train the trainer” programs that can enhance a staff’s knowledge. Well-documented standard operating procedures are also an important tool for ensuring clinical trial continuity in emerging regions.

IV) Infrastructure, especially logistics. Infrastructure creates unique challenges from country to country. For example, a specific region within a country might be prone to frequent power outages, which can impact refrigerated drugs. It’s important to properly prepare a clinical trial for situations that might not typically impact a study conducted in a Western country. Sponsors and CROs can mitigate risk and create confidence in their infrastructure by leveraging external quality assurance and international audits. External audits help ensure that the work aligns with quality standards, such as Good Clinical Laboratory Practice (GCLP), common in Western regions. Though the pandemic’s impact made it difficult to establish international audits, emerging geographies were well prepared to ensure trial integrity, and it will likely become easier to conduct those audits in the near future to continue elevating clinical trial standards globally. Logistics is a key infrastructure consideration. Clinical trials require not just equipment but a continual stream of ancillaries moving across multiple jurisdictions. Sponsors and CROs should consider experienced freight management partners to transport, protect, and track valuable assets and ensure supply chain integrity. Digitalization tools can also play an important role in overcoming logistics challenges. For example, a kit with a scannable label can be tracked across the entire supply chain – from the kit assembly line to the clinical trial site to the laboratory and, eventually, to the biorepository.

As the demand for clinical trials grows, emerging regions are increasingly valued partners. But only by understanding – and addressing – the challenges, can sponsors and CROs fully benefit from potential advantages that allow researchers to get life-saving treatments to market faster.

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About the Author
Claudia Berron

Claudia Berrón is Senior VP, Clinical Services at Avantor

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