As 2016 came to a close, many of us spent time reflecting and forecasting for the next year. The clinical research industry has continued to experience significant change and 2016 was no exception. We explored many topics, most notably patient-centricity, methods aimed at streamlining processes and proactive ways to handle study startup. These themes will continue to remain industry discussion topics and new site models will set trends moving forward.

This year, we look forward to new directions and opportunities for research site revenue. As science advances and collaboration among industry leaders continues, increasing research will be conducted on combination products. According to a study conducted by Grand View Research, the drug-device combination market is expected to grow—reaching $177.7 billion by 2024.

Generic drugs will be a growth driver for research sites this year and in years to come. With many key patents set to expire, sites will be faced with a growing number of opportunities to conduct bioequivalence studies. Worldwide growth is anticipated in the generic markets, bringing increased potential for site revenue.

The biosimilars market is in its early stages, especially in the U.S., but is expected to grow in the next few years. A recent report, “Global Biosimilar Market: Size, Trends & Forecasts 2016-2020,” identifies Sandoz, Amgen, Celltrion and Pfizer as key players in the biosimilars space. It will be important for sites to keep an eye on potential opportunities as this market continues to evolve.

As key stakeholders in clinical research, sites are becoming more recognized for their importance within the industry, leading to increased collaboration. As a result, more initiatives are taking place to help ensure site sustainability. Sites may begin to see consistency in contract clauses, or new measures taking place regarding site payments.

Resulting from industry collaboration, an increased emphasis in handling site payments will be a trend moving forward. Sponsors and CROs realize the importance of consistently paying sites on time, and will work to improve this process. Additionally, many electronic platforms will continue to come to market, aimed at streamlining the site payment process. 

The growth in sophistication and capability of larger site networks and SMOs is likely to continue in 2017. It will be interesting to watch how these organizations define and evolve their models.  Independent sites will likely respond to this industry change by fine tuning to their own internal processes.

There is increased emphasis on the relationship between sites and the CRO. We explored this topic earlier in 2016, and will continue to see strategy implemented to strengthen these relationships. The overall goal is to bring more efficiency to the clinical trials process by allowing for more collaboration between CROs and sites.

Last month, we explored the need for diversity in clinical research. There was a push for diversity from the FDA in 2016, with several initiatives launched to support this. It is likely this will continue in 2017 as new strategy unfolds aimed at diversifying patient populations. As sites continue to share ideas and methods related to increasing diversity, the community as a whole must begin to implement their own plan to bring clinical trial awareness to a broader population of patients.

In addition to diversifying the patient population, sites are continually looking at ways to adopt patient-centric methods into their model. We explored this concept and discussed the importance of finding opportunities throughout the study process to establish patient-centricity. It is becoming apparent that patient-centricity is no longer simply a buzz word.

Technology, of course, remains a driving force for industry change. The industrial internet and the rise of smart devices will continue to remain at the forefront of discussion. Research sites that are able to adapt to these changes will see almost immediate benefits. The ability to have access to real-time data will give sites an advantage, particularly when it comes to tailoring their plans towards a patient-centric model. 

Altered business models and the rise of new technologies will continue to drive change in the clinical research industry. 2017 is shaping up to be an exciting year for research sites faced with potential opportunities in existing and emerging markets. With an industry focused on helping sites diversify and increase patient populations while maximizing efficiency, we can be hopeful many of these changes will shift in favor of site sustainability. 

Dr. Christophe Berthoux has been the chief executive officer at Synexus since September 2010. Synexus is the world’s leading site management organization (SMO), dedicated to the recruitment and management of clinical trials across the globe for over 24 years. Synexus is proud to be the patient’s choice for clinical research. Email comments and questions to sarah@vanepercy.com.

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