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International Clinical Trials

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There is a host of challenges when it comes to conducting clinical trials in early-stage emerging markets where they are only just starting to appear – for example, areas of Africa, Asia and South America. Quite apart from issues with local regulatory and legal requirements, cultural and religious differences, unmet training requirements and good clinical practice compliance, key problems often arise with trial logistics and missing or unreliable infrastructure. These issues may be present in the form of slow postal and courier delivery, poor-quality or non-existent roads, nonfunctional phone lines and internet access, and missing facilities in potential investigator sites.

Electronic data capture (EDC) can help overcome these issues. Its key benefit is to make clinical data available to all stakeholders immediately. This is a huge advantage in developed and emerging markets, enabling data to be delivered and cleaned on time, without the need to courier case report forms (CRFs) or queries overnight, or having to wait for a period of days until they arrive via regular mail.

The main issues with EDC in emerging markets relate to connectivity and accessibility. In some countries, internet access is restricted due to legal requirements, so investigator sites may be affected by unreliable or interrupted internet connectivity. Some sites may not even have internet access and/or a computer. When selecting countries in which to conduct clinical trials, pharma companies should check the legal situation and evaluate – preferably with local affiliates – local contract research organisation or investigator sites, and the steps required to ensure proper access privileges for the trial. If internet access needs to be introduced to the investigator site, a provider should be chosen that can guarantee the required connectivity stability and speed.

Connectivity Solutions

Connection stability and speed issues require detailed technical attention. During EDC vendor selection, look specifically for companies with experience in emerging markets, preferably in the countries where the clinical trial is intended to be run, as they will be in tune with the special needs of those markets.

The initial step is to check the required bandwidth. If the connection is unstable or frequently interrupted, a special low-bandwidth version of the EDC system will be helpful. Other alternatives are to source another, more reliable internet or phone provider, or to use connection acceleration software or hardware.

If a stable landline connection cannot be arranged, a mobile phone connection may be the solution. However, basic mobile connection speed is relatively slow, so the use of a low-bandwidth EDC system or connection acceleration software will be necessary. Where landline or mobile connections are either unavailable or unreliable, a satellite connection may be the answer – especially considering its current affordability.

It should be noted that in some countries, such as India, satellite connections are legally restricted or require a licence. In such a situation, an EDC system with a local storage module could be used, with the data entered being stored locally and transferred onto the database server as soon as a connection becomes available. This should really be a last resort option. By storing the data locally, the main benefit of EDC – the availability of the most current version of the data immediately for all stakeholders – could be lost. For example, clinical data management or the medical monitor may issue a query that would never have been issued if the latest data changes, still waiting in the local storage module, had been available to the data reviewer.

In order to avoid burdening sites with poor EDC performance, these issues need to be addressed during trial planning by bringing on board the EDC provider or an independent expert early in the process. As with most challenges, good and early planning is the best risk mitigation strategy.

Time Savings

The main benefit of using EDC in emerging markets is the time saved when getting data. This will speed up trial timelines and therefore time-to-market, freeing up additional time during the patent protection period. In addition, data review will happen in real-time (automated edit checks) or in a very short timeframe (manual edit checks, sometimes referred to as remote monitoring), resulting in fast data cleaning and avoidance of systematic errors. As data cleaning is performed completely electronically, the monitor no longer has the burden of initial data review, but can concentrate on his core competencies of site management, good clinical practice compliance checks and source data verification. This allows for shorter and less frequent monitoring visits. Also, courier costs will be saved because CRFs and queries no longer need to be shipped across the world.

Conclusion

The costs of investing in internet connectivity and computers for investigator sites are far outweighed by the savings that can be generated in terms of lower cost, reduced timelines and shorter time-to-market. The provision of free internet connectivity or free computers can also act as an incentive, helping to increase subject recruitment rates and therefore extend the patent protection period. Studies have shown that about 80 per cent of all delays in clinical trials are due to poor subject recruitment, so there is a clear additional advantage to be gained

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Martin Stricker is the Global Head of Data Management at SIRO Clinpharm. With over 12 years of experience in data management, he is responsible for organising and coordinating the team, deliverables, finance and technology. He leads creation, maintenance, communication and training of the Data Management Standard Operations Procedures. Martin has worked on various eClinical platforms, among them the EDC systems Oracle Clinical RDC and InForm, and was previously the Head of Data Management at a mid-sized German CRO.
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