Clinical Research is always changing and expanding, many countries that were considered inaccessible to clinical research are now opening their doors and joining the global clinical trial marketplace. Patients who were previously unable to access clinical research now have the opportunity.
MRN has a clear and straightforward set of business objectives to drive expanded access to trials – conducting clinical trial activity in an alternate location from the site, (usually in-home), reducing the impact of the trial on the patient’s day-to-day life, and improving recruitment and retention and speeding up the trial.
Drivers
Objective 1: to operate globally. A global operation means we can reach as many patients as possible; the more patients have access to a decentralized service, the faster the trial can complete.
Objective 2: Maintain high quality for Health Care Professional (HCP) care of patients, regulatory compliance, and data quality.
Global Expansion
MRN started out in 2006 as a UK based company, shortly expanding to Spain and the rest of Western Europe, then to eastern Europe, Australasia, and the US. In 2021 we opened up our most recent office in Tokyo, Japan and continue to expand our clinical trial delivery, operating in 2023 for the first time in Argentina and Croatia.
We know our partners in Pharma are being driven to complete clinical trials across the globe for a number of reasons and are always looking at how we can best support them in this endeavour.
There are a number of areas of the globe that are currently being more deeply investigated for clinical research, China, Japan, South Korea, and Latin America are high up on that list.
“China represents the fourth biggest economy on the planet and its own drug market is growing at a pace that is enviable to any western market, at 28 per cent CAGR.”1 The patient population of China is large and many meet eligibility criteria for taking part in clinical research. The country is not naïve to clinical research, it has a very strong clinical infrastructure and large pools of talent, but there are of course cultural considerations that ‘Western’ companies moving into this country would need to tackle such as, language, hierarchy, and organizational structures.
South Korea is another country that is being highlighted as a potential shining light in clinical research moving forward. With its “…high population density, westernized diseases and world-class health care infrastructure, South Korea is a destination of choice for clinical research.”2 Many of these positives we have already seen with our expansion into Japan.
Another area of consideration is Latin America. “Latin America has over 650 million people; over 80 percent of them live in urban areas.”3 This means they will have access to healthcare teams and infrastructures which could lead to improved levels of patient recruitment and retention within these spaces.
Maintaining high quality delivery
As well as our focus on global expansion, quality for us is key. Several years ago, MRN achieved sufficient scale to start hiring HCPs directly. This delivers benefits across both of the objectives above by allowing long-term training in trial activities, career development, and higher levels of staff engagement. Full-time or Part time direct employment provides coverage for high-demand areas where utilization of the HCPs can remain reliably high and provides a pool of HCPs that can travel to less populated areas. B2B networks can then also be utilized to supplement direct hire HCP resource as needed on a per diem model, maintaining our global reach. This approach provides coverage for all geographical areas allowing participation by all trial patients if they wish, so speeding up recruitment.
Direct management, training and a centralised Quality Management System is applied to all HCPs universally. This central oversight ensures a high standard of documentation and compliance is met in all geographical areas and that the standards set by the customer can be propagated easily to the whole trial. We combine this with “local” country or regional staff to provide language and cultural input giving sites and PIs local contacts and confidence in the system.
With technology and travel making more and more of the world accessible to more and more people it’s only a matter of time before more regions and countries open themselves up to clinical research and MRN have the experience, drive, and expertise to deliver.
Author:
Elaine Wylie, Chief International Development Officer
References
1 – Clinical Trials in China & Japan, Wright, Nick, https://www.pharmafocusasia.com/clinical-trials/clinical-trials-china-japan
2 – Gateways to Asia: Market Access in Japan and South Korea, Informa, https://en.cmicgroup.com/wp-content/uploads/2021/07/White-paper-Gateways-To-Asia-Market-Access-In-Japan-And-South-Korea_Final-2.pdf
3 – Latin America: A compelling Region to Conduct Your Clinical Trials, Martinez-Clark, Julio G., https://www.clinicalleader.com/doc/latin-america-a-compelling-region-to-conduct-your-clinical-trials-0001