Why international studies need a vendor with international experience

The volume of international studies is growing, with the market for global clinical trials expected to be worth $65.2 billion by 2025. Some of the key drivers of the increased globalization of clinical studies include the expanding R&D investments by drug developers in emerging health markets, the growing interest and expanding exploration of new and high precision medicines, the application of advancing technologies in clinical development, and the continuous identification of unmet clinical needs.

However, while there is growth in the global clinical trials market, specific challenges continue to limit the success of international studies for many drug developers. Regulatory complexities across health markets, lack of skilled clinical researchers, difficulty in integrating new technologies, encompassed within the clinical trial burden are just some of the restraints to success.

Patient recruitment is an area of clinical research where we commonly see inefficiencies. Pharma companies of all sizes and geographies struggle to optimize patient enrollment and minimize dropout. Between 2013 and 2017, phase 3 studies had an average of 622 patients per trial even though the target number of participants in a typical study is in the thousands. In addition, it is estimated that 48% of clinical sites miss their enrollment targets, while 80% of clinical trials also experience delays due to challenges in the recruitment process.

A closer look at the challenge of patient recruitment in international studies reveals that many challenges arise from having to account for diversity in patient populations. This creates challenges when trying to reach participants effectively, as well as monitoring them successfully. While pharma companies are investing in clinical development, dedicating so much time and energy specifically towards patient enrollment in international studies remains a common struggle for many pharma companies.

If pharma companies do not deal with restraints to the success of international studies, they might also fail to fully harness the clinical innovation that modern clinical studies offer. While this is a costly mistake financially, it is also leading to drawbacks in terms of patient care. With inefficiencies in international trials, companies might not be able to develop new treatments that can truly address unmet medical needs we see today.

The need for international experience

Companies can address the hurdles to successfully implemented international studies through operational enhancements that can facilitate – on a global scale – improved patient recruitment, development efficiency, and innovative clinical approaches.

Essentially, what is lacking in many teams that are tasked with the design and implementation of global studies, is previous experience of conducting international studies. This previous experience is characterized by:

  • A deep understanding of various international health markets and patient populations
  • A firm focus on patient recruitment
  • Clear communication lines with the target patient population
  • An ability to locate participants with efficiency across the globe
  • An ability to engage eligible patients across various health markets in different languages
  • Skills in executing targeted digital advertising
  • An ability to apply patient-centricity principles in the trial design.

This level of expertise can only be acquired and formed through years of recruiting patients and conducting hundreds, if not, thousands of clinical trials in different countries. This kind of experience in global studies can be found in select international clinical vendors that have a vast global reach, awareness of patient-centricity, and knowledge of specific health markets.

Vendors with international experience offer a global reach of patients

International experience means that a vendor has an effective formula for patient recruitment, as well as other proven solutions for recruiting quality patients onto a study, as they have the capability to locate and engage prospective participants efficiently. A key step that international vendors take is recruitment communication planning, where they map out and develop creative solutions to deliver appropriate materials through the right channels in order to effectively reach patients. Given the international scope of a study, one creative solution of experienced patient recruiters is to utilize online advertising campaigns. Digital advertising casts a wider net for eligible patients from different regions in a shorter amount of time than traditional recruitment methods.

Having a global reach means that a vendor ensures there is clear communication with the target patient population, so making sure your vendor is proficient in way of different languages can prove key to successful global recruitment. For example, at Clariness, we can speak 29 languages internally, and this diversity has helped to drive the success of our patient recruitment efforts for our clients. Speaking in the local language facilitates engagement and understanding. It also means the vendor can contribute to the design of a study by ensuring that information materials, awareness campaigns, and enrollment efforts are tailored to the language of a specific patient population. By making information available in a patient’s language, pharma companies can facilitate a patient’s comprehension of the objectives, design, and protocols of a study, and potentially increase their interest in enrollment.

Experienced international vendors can facilitate patient-centricity

Beyond use of local language, an experienced international vendor also identifies and takes to heart the nuances in patient needs across different regions of the globe. In contrast, not all sponsors can effectively engage individual patients to gather feedback on study protocol complexities. While many sponsors consider the “burden” of a study, they often only refer to a burden related to the clinical site and not a burden on the individual patient. Patient input can be fundamental in trial design and site selection, but many sponsors view this as time-consuming and costly, as they would need to take time to meet with patients and translate their input. They would also need to translate scientific protocol into words that patients can understand and be able to comment on.

Reducing patient burden is a considerable matter of concern in trial design, which when addressed effectively can help to minimize dropout. Consciously reducing patient burden is a key component of patient-centricity, and it can only happen by listening to the voice of the patient in the context of the healthcare market they are in. While sponsors might not have the time to drive patient-centricity in a study, experienced international vendors are equipped with the right tools, such as digital surveys, to gather country-relevant input on patient burden.

Vendors with international experience can also provide patient assistance in clinical sites. They can prepare quality support services such as connecting participants with clinical investigators, offering concierge services, and consistent patient monitoring, tailoring these to the different geographies of patients.

Internationally experienced vendors have insights on local health markets

For clinical studies to succeed on a global scale, companies must ensure the study design has a solid foundation at the local level. Knowledge of, and expertise in, local markets is essential to be able to plan an effective international study. There needs to be a deep understanding of specific regulatory complexities and a regard for nuances between patient populations. Having expertise on varied health populations supports the development of an appropriate trial design and efficient study implementation process.

Experienced vendors will also have an operational framework for international studies. This will comprise methods of identifying and engaging local stakeholders who have a role in recruiting participants for research, facilitating patient communication, and running a trial.10 The framework would also comprise criteria for appropriate site selection, including site infrastructure, site capabilities, investigator experience, access to the target patient population, and access to resources, among others. This framework must also integrate how the existing network of the patient population and international site relationship managers, clinical researchers, patient screening specialists, and other partner professionals of a vendor can be leveraged to benefit the international study.

International clinical research recruiters will have a broad understanding of the challenges in conducting global studies, and having the capability to overcome these challenges can only come from years of experience. So, for pharma companies aiming to drive cost-efficiency and value from their global studies, working with an experienced patient recruiter is necessary. Specifically, it is vital to seek support from vendors that specialize in recruiting global participants for research and integrating patient-centricity into the local context of clinical sites. The right vendor will be able to bring a global perspective to the planning and execution of a clinical study.

By leveraging a vendor’s international experience, pharma companies can achieve target enrolment rates, generate meaningful scientific findings, launch new treatments on time, and improve return on clinical development investments.

To find out more about the extensive international experience of Clariness, contact us at: https://www.clariness.com/contact-us/

References

  1. Center Watch (September 2017). Report: Global clinical trials market is expected to reach 65.2B by 2025. Available at: https://www.centerwatch.com/news-online/2017/09/25/report-global-clinical-trials-market-expected-reach-65-2b-2025/ [Accessed on January 14, 2019]
  2. Center Watch (September 2017). Report: Global clinical trials market is expected to reach 65.2B by 2025. Available at: https://www.centerwatch.com/news-online/2017/09/25/report-global-clinical-trials-market-expected-reach-65-2b-2025/ [Accessed on January 14, 2019]
  3.  Business Wire (December, 2018). Global Clinical Trials Market by Phase, Design and Geography – Growth, Trends and Forecast (2018-2023) – ResearchAndMarkets.com. Available at: https://www.businesswire.com/news/home/20181207005437/en/Global-Clinical-Trials-Market-Phase-Design-Geography [Accessed on January 14, 2019]
  4. Handen, J. and Patrick, D. (August, 2018). 3 Major Challenges with Global Clinical Trials — And How to Overcome Them. Clinical Leader. Available at: https://www.clinicalleader.com/doc/major-challenges-with-global-clinical-trials-and-how-to-overcome-them-0001 [Accessed on January 14, 2019]
  5. Handen, J. (May, 2018). What Does Patient-Centricity Really Mean … And Why Do We Need It? Clinical Leader. Available at: https://www.clinicalleader.com/doc/what-does-patient-centricity-really-mean-and-why-do-we-need-it-0001 [Accessed on January 14, 2019]
  6. Handen, J. and Patrick, D. (August, 2018). 3 Major Challenges with Global Clinical Trials — And How to Overcome Them. Clinical Leader. Available at: https://www.clinicalleader.com/doc/major-challenges-with-global-clinical-trials-and-how-to-overcome-them-0001 [Accessed on January 14, 2019]
  7. Huanga, G., Bull, J., McKee, K., Mahon, E. Harper, B. and Roberts. J. (2018). Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative, Contemporary Clinical Trials, Volume 66, March 2018, Pages 74-79. Available at: https://www.sciencedirect.com/science/article/pii/S155171441730753X [Accessed on January 14, 2019]
  8. Anderson, D., Fox, J. and Elsner, N. (2018). Digital R&DTransforming the future of clinical development. Deloitte. Available at: https://www2.deloitte.com/insights/us/en/industry/life-sciences/digital-research-and-development-clinical-strategy.html [Accessed 6th January 2019]
  9. Handen, J. (May, 2018). What Does Patient-Centricity Really Mean … And Why Do We Need It? Clinical Leader. Available at: https://www.clinicalleader.com/doc/what-does-patient-centricity-really-mean-and-why-do-we-need-it-0001 [Accessed on January 14, 2019]
  10. Huanga, G., Bull, J., McKee, K., Mahon, E. Harper, B. and Roberts. J. (2018). Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative, Contemporary Clinical Trials, Volume 66, March 2018, Pages 74-79. Available at: https://www.sciencedirect.com/science/article/pii/S155171441730753X [Accessed on January 14, 2019]