Taking an uncommon approach to learning about the industry’s changing landscape, Worldwide surveyed drug development leaders and executives to discover key areas that sponsors should explore when searching for a CRO that can make a positive impact on their studies
Worldwide Clinical Trials, Inc. (Worldwide), an award-winning, full-service clinical research organization (CRO), today announced the results of its 3rd annual survey, which is conducted to capture insight from pharmaceutical and biotech executives and better understand evolving sponsor preferences in the context of drug development barriers and opportunities.
Clinical trials today are complex and need greater efficiency, higher quality and risk mitigation. Worldwide collected more than 350 survey responses from executives in clinical operations, outsourcing, regulatory affairs and drug safety, representing 169 unique organizations. The aim of the survey is to better understand and reimagine the CRO/sponsor relationship and gain deeper insight into the complexities and realities of the inevitable challenges that will arise during a trial. The 3rd annual survey revealed five trends in areas where CROs can provide the most innovative impact to sponsor partnerships:
- There is a growing urgency for CRO expertise in early phase clinical research, i.e., first-in-human through proof of concept. The percentage of respondents who were either “likely” or “very likely” to engage a CRO grew most sharply for early phase investigations, up 8 percent – from 55 percent in 2016 to 63 percent in 2017. This uptick likely reflects the new cycle of compounds coming into early development as well as the lack of facility resources and limited operational expertise.
- There is stable growth in the overall demand for CROs. Sixty-eight percent of respondents said they were “much more likely” to hire a CRO than they were five years ago, in comparison to 65 percent in 2016. This demonstrates that CROs are consistently providing value to sponsors by enabling sponsors to outsource services and focus on drug development rather than establishing clinical trial processes.
- Data quality tops the list of CRO evaluation criteria. In both 2016 and 2017, the most important factor in choosing a CRO was the ability to deliver high-quality data – with 96 percent in 2016 and 92 percent in 2017. This highlights the importance of establishing standards for data management to ensure consistency in gathering high-quality, reliable and statistically sound data.
- Sponsors are looking for CROs that provide innovative solutions. Thirty-six percent of respondents ranked “Overall trial management” as the area that can make the greatest impact for the sponsor/CRO relationship. This reflects the demand for game-changing advancements for uncured diseases, such as Alzheimer’s and a wide range of orphan indications that do not have well-established precedent.
- Sponsors continue to push for clinical trial efficiencies. The cost of clinical development remains the most significant barrier to developing a new drug. With various obstacles to consider, 74 percent still said that costs are “significant” or “very significant” to new drug development.
“By 2020 it is estimated almost 75 percent of all clinical trials will be run by CROs[i], yet the CRO/sponsor relationship remains a transactional one,” said Peter Benton, president and COO, Worldwide Clinical Trials. “Thank you to the biopharma and pharma leaders who provided survey input and who stand with Worldwide to ensure sponsors can gain efficiencies and boost quality through CRO outsourcing. The industry’s input helps us continue our work to implement operational and clinical innovations that will help bring new therapies to market faster with the highest quality data possible.”
First launched in 2016 at conferences such as the Drug Information Association (DIA) annual meeting and the Biotechnology Innovation Organization (BIO) annual meeting, the Worldwide survey seeks to understand what makes sponsor and CRO partnerships successful by exploring preferences in the context of drug development barriers and opportunities.
For further details, the full report can be downloaded here, at which time clinical leaders can also participate in the survey for next year’s report.
For further information about Worldwide Clinical Trials, please visit Worldwide.com.
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About Worldwide Clinical Trials
Worldwide Clinical Trials employs more than 1,600 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs – in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, immune-mediated inflammatory disorders (IMID), oncology and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO. For more information, visit https://www.worldwide.com.
Worldwide Clinical Trials
[i] PharmaVoice, June 2015, Clinical Solutions: Clinical Services Market Poised For Growth