17 Sep Five Trends Shaping Clinical Trials Outsourcing
As drug, biologic and medical device makers continue to right size their organizations, outsourcing of clinical trials has become very common. In fact, it is now a strategic imperative. Complex trials and global patient populations, quality and compliance concerns, along with continuing cost and competitive time-to-market pressures all play a role in clinical trial outsourcing trends.
CenterWatch Research and Markets forecasts that the global clinical trial services market will likely reach more than $64 billion by 2020. The competitive Contract Research Organization (CRO) can ride this wave by engaging sponsors in discussions that clearly articulate their readiness and ability to address these trends in unique and meaningful ways. CROs can differentiate themselves by offering the depth of knowledge and breadth of experience that sponsors can’t afford to maintain internally.
Five key trends that are impacting clinical trials are noted below. They have a direct impact on CRO teams, and how they position themselves as the partner of choice.
- Expansion of technology enabled trials
Trend: Increasingly, clinical trial sponsors are leveraging technology to advance research and development efforts. Historically, technology focused on three major areas – electronic data capture (EDC), electronic patient reported outcomes (ePRO) and clinical trial management systems (CTMS). Today, these systems are in common use. In addition, web-based platforms are now connecting sponsors, clinicians and patients with electronic medical records (EMR/EHR) and other relevant data types. These platforms also connect other stakeholders in the clinical trial process. Artificial intelligence (AI) is also being used to automate data cleansing and transformation processes. Even trial participants are utilizing new technologies as wearables and the internet of things (IoT) have multiplied the ways that data is collected, the types of data being collected and the how it is analyzed and used.
CROs that can leverage innovative technology to communicate more effectively with clinical trial stakeholders, add efficiency to trial efforts or increase the quality of these processes and their deliverables will be well-positioned to take advantage of this trend.
- Patient-centric approach to research
Trend: Patient-centric approaches to clinical trials have emerged as the new way of doing business. There are so many ways to bring the patient voice into the clinical research process. However, unlike other stakeholders in the process, trial participants don’t typically have a background in clinical research. Any communications being developed for this audience must be tailored to their specific needs – everything from font size to linguistics to comprehension level and appropriateness of channels must be carefully considered. Patient advocates are already calling for greater transparency in clinical research and pressuring sponsor organizations for quicker, more accurate clinical trial information to be shared across the marketplace.
This trend will undoubtedly lead to more frequent, better designed, multi-channel communications between sponsors and this new and growing audience. As sponsors determine new ways to integrate the patient voice into clinical research, additional opportunities for CROs to support these efforts with value-added services will materialize.
- Globalization of clinical trials and focus on emerging markets
Trend: Clinical trial sponsors wish to expand recruiting efforts to emerging markets for two main reasons. In most cases, these markets represent a potential to decrease recruiting costs. Simultaneously, they also represent a new, expanded pool of potential trial participants. Both of these attributes are motivating sponsors to move into new markets. However, these new markets also represent an entirely new set of regulatory requirements that must be met on an ongoing basis. Required compliance documentation must be readily available and accessible for local stakeholders, ranging from patients to health authorities.
These untapped, low-cost regions present a great opportunity for CROs to add value to clinical trial offerings. Offshoring of clinical trial services in these regions may be a solid strategy but requires an understanding of local culture and communication styles. Culture differences, language and dialect challenges can erode this value and increase the cost of service very quickly. Careful planning and research of communication strategies will help CROs to avoid costly mistakes in these emerging marketplaces.
- Strategic partnerships with CROs
Trend: Many trial sponsors are looking for strategic partners to handle the full gamut of clinical trial services from recruitment to reporting. Many also need specialist CROs with specific knowledge and experience in a particular therapeutic area. As sponsors look for development partners that bring breadth and depth of expertise to the trial, they are often considering how they might work with these partners more closely to increase efficiency and decrease costs. The Association of Clinical Research Organizations (ACRO), shares some notable metrics on their website:
- According to the Tufts Center for the Study of Drug Development, clinical trials conducted by CROs are completed on average 30 percent more quickly than those conducted in-house.
- This results in an average time savings of some four to five months, translating to $120 million to $150 million in increased revenue potential.
CROs that offer greater value across the project will be well-positioned to attract and maintain longer-term partnership opportunities. Adjacent services that add value to sponsors current capabilities without requiring administration of additional contracts with multiple vendors will become strong differentiators.
- Innovation is a priority that is driving change
Trend: There isn’t one aspect of the clinical research process that is not being transformed by innovation. Analysis Group suggests that as of August 2016, “approximately three quarters (74% percent) of clinical phase projects were potentially first-in-class. Combination medical device and drug products, radiopharmaceuticals and other exciting new innovations are creating new market opportunities. The science is novel and so are the R&D approaches. Large pharmaceutical and biotechnology organizations are partnering with small, nimble, early-stage teams to combine global capacity with agility. Company structures are changing to accommodate rapidly growing pipelines. Patients, clinicians, and researchers are connecting and communicating more efficiently using new technologies and optimized processes.
Most stakeholders in the clinical trial process understand how essential innovation is to successful research. Business as usual is not enough anymore. CROs often lead the way into uncharted territory as evolving market demands shift. New science and technology and ever-present pricing pressures will continue to demand innovation throughout the CRO world.
Summary: The contract research market is expected to continue to grow. Competitive CROs must prioritize global offerings that reduce time and cost and increase the quality of clinical research. Expanding markets will bring additional compliance burdens and challenges relating to diverse cultures, languages, and dialects.
The SDL team has the experience required to help CROs identify and rapidly expand into new regions with translation and localization services that are staffed by local language experts. Our language solutions are designed and deployed by a team with a unique combination of life sciences expertise and a practical understanding of the nuances of vocabularies, cultures and languages.
SDL is the preferred translation partner for numerous CROs around the world. Contact us today to learn how we can reduce the time and cost of your R&D translations while improving the quality of your content.
 https://www.acrohealth.org/media-center/fact-sheet/, accessed September 12, 2018
 The Biopharmaceutical Pipeline: Innovative Therapies in Clinical Development, July 2017, Analysis Group, Inc.