Navigating the Globalisation of Clinical Trials
Navigating the Globalisation of Clinical Trials by Christian Hebenstreit, General Manager & Senior Vice President EMEA, Medidata Solutions
The globalisation of clinical trials is not only helping to significantly reduce costs and accelerate time-to-market, but also helping to address major challenges in drug development
Global prescription drug sales are expected to reach more than $1 trillion by 2020. This growth trajectory brings with it a series of challenges, including appropriately adopting and leveraging emerging technologies, navigating new regulatory requirements, and understanding more complex supply chains, among others. These challenges, if not addressed and mitigated, can significantly increase the cost and time needed to bring new drugs to market - a pressure point the industry is well familiar with. Clinical trials have also become increasingly costly ventures, adding to the overall cost of drug development and, in the end, the price that patients pay for potentially life-saving drugs. The requirement of large sample sizes and the opportunity for faster patient recruitment and enrolment has massively driven the globalisation of clinical studies and, ultimately, supported faster completion of trials.
Clinical researchers need to think globally
Today, almost half of clinical trials take place outside of the United States as emerging countries are investing heavily in the sector across all areas, from R&D to infrastructure. According to industry analysts, by 2020, it is expected that 67% of all clinical trials will take place in developed countries, down from 76% today, and that clinical trials in emerging markets will make up 25%, up from 16% today.
The increasing trend toward conducting clinical trials across the world is an important consideration in improving the efficiency. Whether it’s applicable to conduct a clinical trial overseas or not will depend on many factors such as the disease being studied, the population most prone to said disease, and the state of current clinical practice in that area, but it is generally agreed that globalisation is a positive trend. If a large trial requires finding and enrolling thousands of patients, selecting trial sites globally can result in massive time and cost savings.
This also gives us more opportunities to find the precise patients to conduct clinical trials more effectively and, in the end, lead to more successful outcomes. There has been significant scientific advancement in identifying specific drugs for specific people, due to their unique genetic makeup and the same approach should be taken when conducting clinical trials. By doing so, and operating under the “customisation of healthcare” model, medical decisions and treatments can be tailored to individual patients or patient groups - an obviously more effective approach.
The challenges of globalisation
Across the healthcare spectrum, from big pharmas and small biotechs to academic institutions and research organisations, companies are looking for innovative ways to lower the costs of clinical trials - by recruiting patients more effectively, making use of virtual trials, monitoring how drugs are administered and being more flexible during a trial (or what we call ‘adaptive trials’) - and, in turn, also improve clinical trial outcomes. However, the globalisation of trials presents new considerations - economic or political uncertainty, different quality standards, legal and ethical issues, incompatible approval processes or tough regulatory environments - meaning they have also become increasingly complicated and require more effort and attention to manage.
Gathering the necessary resources to conduct a clinical trial, and the overall costs associated, is still one of the biggest challenges for the global life sciences industry. While broadening the clinical trial universe certainly benefits patient recruitment and diversity, it also multiplies the operational and strategic obstacles that clinical professionals must bypass. Certain countries will inevitably be less experienced in conducting them and therefore need additional guidance in order to minimise risk and promote the most optimal outcomes.
It is easy to underestimate some of the operational and logistical challenges that emerging markets might face when conducting clinical trials - issues that countries such as the United States, United Kingdom, France and Germany, probably haven’t experienced in decades. For example, physically transporting drugs or medical resources from point A to point B may seem like a straightforward task, but doing so in a country with less developed transport infrastructure can reveal unexpected hurdles. It can be equally challenging transporting patients to and from clinical trial sites. Likewise, high-speed internet may not be available, or may be unreliable, causing unforeseen delays and the potential inability to communicate with other medical centres or trial sites.
These are all challenges that need to be addressed and understood early on when working on a global scale in order to, ultimately, minimise the impact on the overall clinical trial process and outcome.
Getting globalisation right
To address these challenges, it’s vital to gain a clear understanding of the dynamics of the country you might want to conduct a study in. Proper due diligence and research are essential before selecting a new site from which to run a clinical trial, especially if conducting cross-country studies. Healthcare organisations - from the sponsor to the investigator to the CRO - need to take into account, and almost anticipate, all the possible challenges that could arise. Making reactive changes at a later stage can be costly for all involved in the trial, especially the patients. This ultimately puts the submission to the regulator at risk as the sponsor might be asked to rework some areas of the study, further delaying the delivery of drugs to patients. Being acutely aware of the obstacles upfront can help to avoid this.
Luckily, as an industry, we are addressing these issues and complexities everyday - collaborating across countries and across organisations to find new and better ways to run clinical trials more effectively. It’s a continuous learning curve but the common ambition and goal is to improve patient experiences and outcomes, and bring life-saving drugs to patients faster.
We're also starting to benefit massively from new technologies, making substantial use of cloud computing, artificial intelligence and machine learning. These advancements are enabling things like a synthetic control group which can replicate the outcomes of a traditional randomized control group. Using machine learning, it is possible to process 1,000,000 data points with 4,000 patterns in less than an hour. The use of mobile technologies also means it is much easier to gather individual data on a real-time basis and track patients more accurately. It is also something that is greatly improving the patient experience.
The cost and time savings that can be realised through leveraging these new technologies are extremely encouraging and the application within the life sciences sector is still only in its infancy stage - we will continue to see radical evolution and progress here.
The digital health frontier
The extreme advancements we have seen in drug development - driven by new methods, regulation and technology - is encouraging. However, as we know, a new drug approval can take decades and the development cost averages between $1.5-2.6 billion. Additionally, on average, only 1-in-10 drugs gets approved. The biopharmaceutical industry needs to continue to drive these new digital health initiatives, leveraging compliance apps, clinical endpoint and data capture tools, and remote trial delivery systems, as well as find new ways to minimise the complexities around globalising trials.
With an increasing emphasis on patient centricity, we can expect to see growth in virtual trials and patient-centric approaches towards clinical trial execution, as well as new concepts involving patients as advisers for study design and leveraging patients as experts to validate new digital health applications. The exciting penetration of technology across the life sciences industry coupled with increasing collaboration across the sector puts the industry in its strongest position to date. And there’s more to come.