Are Global Clinical Trials Realistic?
As sponsors and CROs face patient recruitment issues, more clinical trials are looking to other countries for willing patients. Here are the benefits and drawbacks to global clinical trials.
Recruiting and retaining patients has long been a challenge for clinical trials. Lack of participation causes nearly one-fifth of all studies to shut down prematurely, and those that continue are often delayed long past their expected completion date. The problem stems both from a lack of awareness and a lack of successful retention plans; reports show that less than 5% of Americans ever participate in a clinical trial, and 30% of patients are likely to withdraw.
Global trials, especially those that include virtual components, have the potential to fill this void by engaging large numbers of patients in communities around the world. While these trials present many opportunities and benefits – especially with remote trial technology on the horizon – there’s no shortage of challenges to consider, either.
An Emerging International Market for Medicine
As more countries invest in healthcare initiatives, the number of clinical trials taking place outside of the US continues to grow. Industry analysts estimate that by 2020, developed countries will account for approximately 66.8% of total trials, down from the current 76%. On the other hand, trials in emerging markets are expected to increase from 15.7% to 25.2% during this same timeframe.
The benefits of global trials are manifold, in part because they introduce life-saving drugs to populations who might not otherwise have access. CROs and sponsors also benefit from a larger pool of potential patients, especially when testing treatments for conditions that predominantly affect certain parts of the world. For example, it makes most sense to test malaria medication in South America or Africa, where the disease is more common.
With a global pool of potential participants, many studies find it more feasible to recruit eligible patients. Another benefit comes from using virtual tools like telemedicine and remote monitoring, which allow patients to complete tasks from their own homes. This added convenience can lower trial costs as well as reduce the risk of a study shutting down due to low enrollment. Participation of a large, diverse population can also speed up the drug approval process, bringing valuable products to the market more quickly.
The Challenge of Global Clinical Trials
Though interest in global clinical trials is rapidly growing, they present many challenges. CROs and sponsors not only need to follow established ethics codes in the United States, but also in the regions where they’re conducting the trial. For example, a study conducted in India, France, and China would likely need to comply with FDA guidelines, international ethics regulations, and regional codes in each location. CROs and sponsors must also be prepared to analyze a large volume of information collected from patients around the world, as well as ensure the validity of data generated outside of the US.
Add wearables and remote monitoring to the mix, and things get even more complicated. Though new technology has the potential to make global trials more common – not to mention less expensive – the data from those devices has to be fully vetted before it can become commonplace in clinical trials. It might take a few more years before trials can fully rely upon data gathered from wearables – but technology is bringing us closer every day.
How Trials Can Recruit on a Global Scale
With the global clinical trial market expected to reach $65.2 billion by 2025, now is the time for clinical trials to consider possibilities abroad. Recruiting patients around the world might seem like a daunting task, but CROs and sponsors can use digital marketing to reach large audiences while keeping costs low. Advertising on social media is an especially effective way to target different populations within a single platform.
Facebook’s demographic targeting tools allow marketers to pinpoint potential patients based on location. Trials can ensure that ads are shown to the right audiences by targeting one or more countries, counties, cities, ZIP codes, or designated areas. This platform also has the potential to identify patients based on their language preferences. For example, a study could set up ad parameters to target Spanish-speakers in Peru, ensuring ads are shown to relevant users.
Though 53% of pharma executives believe that patient enrollment is the most difficult part of conducting clinical trials, opening up studies to global participation may help address this challenge. With the help of digital advertising, CROs and sponsors have the potential to reduce costs and speed up the approval process. Most importantly, these global trials present an opportunity to bring valuable resources to the communities they serve.
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