Competition in the established US and European clinical trial markets remains fierce, with pressure on drug developers to beat rivals to market. As a result, many drug companies are looking to emerging markets for abundant and diverse trial populations, lower operational costs and increased opportunities to develop treatments.
In this post, we explore why emerging markets are growing, the pros and cons they present to drug developers and how technology can help simplify the process, directing the industry towards a more globalised approach to clinical research.
There is a growing middle class in many emerging markets such as Indonesia, Mexico, China, India and Brazil. This means more people can afford to spend money on healthcare and private health insurance, healthcare market researcher Rachel Howard writes.
Additionally, governments in these emerging markets are looking to reform public healthcare and grant easier access to medicine. These two factors working in unison means greater freedom for market developments and increased innovation in clinical research.
Emerging markets comprise the bulk of the world’s next patients, Howard adds, and pharma companies should not and cannot afford to ignore them.
Tropical diseases, which manifest in some emerging markets, have historically been neglected by researchers as they did not present a commercially viable model.
But Howard notes that this is changing, especially when considering the increased interest in treatments for mosquito-borne diseases. In 2016, for example, the vaccine alliance Gavi committed to purchasing $5 million for Merck’s Ebola vaccine.
Comparator trials have become increasingly desirable and useful for pharma companies looking to prove the efficacy of their treatments, says Yasmin Khera at pharmaceutical services company WEP Clinical.
Rather than relying on a placebo, comparator trials compare the investigational drug with a drug already approved for market use. The advantage for developers of the investigational drug is that they can aim to prove their drug is safer and more effective than the drug currently on the market and present these findings when seeking FDA approval.
Yet sourcing comparator drugs can be challenging, which is why many are turning to emerging markets outside of the US and EU. This approach can often be cost effective as comparator drugs in emerging markets such as Asia or Latin America are cheaper. However additional transportation costs and import/export regulations may negate the initial savings.
Khera also explains that in established markets, there is often greater competition from other drug developers. So competitors might not supply sufficient quantity of a comparator drug for the researchers. Emerging markets can help to overcome this challenge.
Emerging markets have also taken major steps to ensure safer and more transparent processes in their clinical research infrastructures and regulatory systems, Khera notes. This means US and EU-based sponsors are becoming increasingly confident about the quality of comparator drugs sourced from these markets. In India and China, bodies have been created to monitor drug sourcing and protection of patents and intellectual property rights.
Intense competition in drug development means developers need to get treatments approved and on the market as quickly as possible. This pressure has been one of the main reasons trial sponsors have sought to conduct studies in emerging markets, lead author Gaurav Puppalwar, Head of Medical Affairs, Emerging Markets, at Wockhardt, explains in an article published in the Open Access Journal of Clinical Trials.
Africa in particular, the researchers argue, presents a variety of national markets that could help deliver drugs to market more quickly. Kenya, Nigeria, Tanzania, Uganda and Zambia all provide diverse study populations, are open to research opportunities and their governments ambitious to promote their countries as high-quality pharmaceutical and health locations.
When it comes to clinical supply forecasting, the more regions involved the better, argues Edoardo Madussi, commercial director at clinical trial services provider Inceptua. “Having more regions involved allows quicker markets to move ahead, which in turn can imply quicker drug development timelines,” he explains.
But it’s not problem free, Madussi adds. Local partners, who are both qualified and reliable, are needed to source and distribute materials. Plus, the more regions involved in a drug’s development, the more regulatory differences will need to be overcome. However, working towards shared, global regulatory guidelines will help resolve this issue. Madussi cites China as a fine example of this regulatory progress.
Indeed, China's regulatory improvements include anti-corruption disciplinary rules to ensure best practice, agrees Kristiana Reynolds, associate solicitor at London-based law firm Reynolds, Porter, Chamberlain. She notes that China is also attractive because of its ageing population as well as the density of the broader population, as both factors lower a trial’s operational costs.
With emerging markets increasingly participating in trials, there has been acknowledgement by those countries and regions that the need exists to ensure their regulations are in better adherence with those set out by the FDA, says the team at pharma and biotech consultancy Cello Health.
Take Latin America and Asia as examples. Over the past five years, the Pan American Network for Drug Regulatory Harmonization and the ASEAN Pharmaceutical Product Working Group respectively, have raised awareness of the need for clear and consistent regulations. It is important to note, however, that much needs to be done yet before these market regulations are suitably aligned with FDA guidelines.
While emerging markets are currently thriving hotspots for clinical research, clinical trial volume is increasing worldwide. In fact, the annual global growth rate of trials is around 10-12 percent, management consultants Jeffrey S. Handen, Ph.D., and Dan Patrick write. Research and development spending is also on the rise, increasing at a compounded annual rate of 1.76 percent in the last 10 years.
The increase in trials has been made possible, in part, due to technological advancements. For instance, wearables and site-remote tech means more patients can participate regardless of their location. Two-way smart technology has also resulted in more patient-centric trials as communication between site and patient is improved with regular reminders and prompts to input data or adhere to the trial drug regimen.
There are many benefits technology brings to global trials, says Greg Reh, vice-chairman, US and Global Life Sciences Leader at Deloitte.
Technology such as social media and better data processing means patients can be reached more easily and their eligibility determined much faster than traditional means. For example, Reh notes that a cloud-based platform helped researchers recruit patients for a rare-disease trial as much as 30 times faster than through traditional recruitment methods.
Using technology that is independent of location means more patients can be accessed and studied far from any trial site, Reh explains. This removes the traveling barriers previously barring patients from participation in trials.
Another valuable addition to the clinical research industry has been the use of blockchain technology, which enables greater collaboration. The secure digital ledger enables safe storage and sharing of valuable trial data as well as manage data across multiple sites.
While palm-held devices have been used historically in patients’ home settings, they have not been the easiest equipment to use given the transfer of patient data from the device to a central data repository.
However, with smartphones and customised applications, the process is being simplified as data is transferred automatically through cell phone networks. The value of this type of technology in global or multinational trials is obvious, as data can be gathered independently of patients being situated at trial sites. It also results in a higher quality of communication, Laura Lovett at Mobi Health News writes.
For example, Parexel’s data collection tool uses Microsoft’s Azure App Services which sends patient data to healthcare teams when the patient’s safety is under threat. This means real-time and relevant data can be used to improve patient treatment and reduce deaths.
In a similar vein to accessing patient data from their homes, the realization of virtual trials has ushered in a new era in clinical research. This could well be the best solution to a market that demands increased patient participation regardless of geography.
An example of this direct-to-patient trial in action can be seen in a recent investigation into patients at risk for rheumatoid arthritis, drug development executive Andreas Koester, M.D., Ph.D. explains. By scanning various sources of real-world patient data, including insurance databases, clinical researchers can identify participants who may be eligible for the study.
More broadly, Koester says, the collection, processing and transferal of data means information from patients, even those deemed ineligible at certain stages of a trial, can be shared with their caregivers and other research teams.
While regulatory concerns persist for drug companies seeking to conduct trials in emerging markets, the pros seem to outweigh the cons. Increased opportunity at lower costs make these markets attractive to drug developers. Technology can ensure trials in these markets deliver high-quality data independent of patient location to bring about a more global approach to clinical research.
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