New Forms of Outreach and Improving Clinical Trial Recruitment and Data Integrity

There’s no dispute that total life-cycle costs of developing a drug are high; these costs continue even post-approval, with approximately $312 million in R&D costs required to support drug products after they have been accepted into the market. ¹ With clinical trials being one of the largest contributors to these costs, improving trial efficiency and the quality of the data is a priority for the industry as outsourcing trials and related services has proven valuable.

According to the 2016 Nice Insight Clinical Research Outsourcing Survey, 56% of respondents reported spending more than $50 million annually on outsourcing, with 18% spending in excess of $100 million. ² Additionally, 76% of respondents reported outsourcing clinical trial services. ² However, as clinical trials continue to demand an increasing level of competence, with sponsors turning to CROs for trial expertise, there is a competitive imperative among potential outsourcing partners to provide new, innovative solutions to clinical trial challenges, which continues to trouble the industry. One of the most significant challenges occurs before these trials even begin, when researchers attempt to recruit participants — a process that can become costly and time-consuming.

Offerings That Companies Acquire or Plan to Acquire From Cros for Clinical Trial Services Needs

Supplementing Recruitment With Social Reach

Historically, trial recruitment has been a challenge and, despite technology, remains as such. A recent study published in PLOS ONE found that nearly 60% of researchers surveyed failed to meet recruitment targets — a problem that can impact the statistical significance and overall success of a trial — or required additional time to meet these targets, delaying development and increasing cost. ³

The Greatest Opportunities for Cost and/or Time Savings When It Comes to Contract Research

Another review, conducted over eight years, found that “only 31% of multi-center randomized controlled trials achieved their original recruitment targets in a timely manner.” ⁵ Technological advancements can help to improve outreach and engagement in this area, and may help to explain why 38% of respondents felt that mobile-enabled innovations for recruiting and communicating with participants presented a great opportunity for cost and/or time savings in Nice Insight’s Annual Pharmaceutical and Biotechnology Outsourcing Survey 2015. Just one year later, 48% of respondents reported outsourcing services related to clinical trial recruiting. ^2,4

The immediacy of communication and the massive reach made possible with social media and digital communication can prove beneficial here, with the PLOS ONE study also finding that supplementing tradi- tional recruitment practices with social media led to a 12-fold increase in recruitment for phase II of the trial in question (as compared to phase I, which only recruited within traditional channels). ³

With that, all related social efforts were responsible for approximately 78% of recruitment during the second phase. ⁸ In addition to extensive reach, recruitment via social media is more cost effective in terms of both paid advertising and direct interaction/outreach (i.e., tweet - ing to followers and/or posting to Facebook/YouTube). When compared to the cost of traditional advertising, which can range from $20 to $500, Facebook ads, for example, typically range from approximately $15 to $20. ⁵ However, if the CRO has an active, respected social media presence, paid advertising may not be necessary; natural engagement is potentially more effective. Despite significant cost and time savings, social forums can also lead to participant issues after a trial is underway. ⁵

Going Social — Open Communications, Open Complaints ... And Concerns

Though social media channels may make it easier to recruit and communicate with trial participants, embracing the social landscape can potentially lead to participant issues as well. The growth of the internet as a trusted health information channel has led to the rise of “eParticipants,” or participants that are active on social media during trial participation. ⁶ In 2013, The Pew Internet Project found that 59% of adults in the U.S. use the internet to search for health-related topics. This does not necessarily mean that these in- teractions are beneficial, however. Social media mis- use during clinical trials — including those via social platforms, forums and blogs — can potentially affect the scientific integrity of a study. ⁶ Participants may even disclose sensitive information such as investigational terminology through these interactions, or compare medications with each other. ⁶

The Center for Information and Study on Clinical Research Participation — a nonprofit organization providing clinical trial research information, education and resources to participants and the general public — is attempting to combat these challenges with, in part, a website called “Smart Talking About Clinical Trials.” This initiative aims to educate participants on the risks of openly discussing study specifics by focusing on the influential power of these networks. ⁷ Though organizations such as the Society for Participatory Medicine encourage the involvement and engagement of patients in health decision-making, CROs and sponsors alike must be aware of the risks that this empowerment introduces; additionally, researchers need to be aware of how attempting to monitor such social interactions can jeopardize their own blinding in the trial. ⁶

Though research in the area of eParticipants is still relatively limited, and CROs are striving to keep pace with upcoming technology while ensuring that they do not invite unanticipated FDA scrutiny in an area marked by little guidance to date, the industry has much to learn and gain from embracing the social space for recruitment efforts. Engaging an outsourcing partner for everything from clinical trial design to clinical trial data management — outsourced by 54% and 50% of respondents, respectively — may allow sponsors to take advantage of existing expertise that could already include work in the digital space. ²

As technology continues to evolve, social platforms grow and system integration becomes deeper across trial sites, sponsors and CROs — an area in which cloud technology will likely play a major role — the digitization of recruitment and other aspects of clinical trials is likely to become a main point of differentiation among CROs looking to innovate in the market. With the term “digital CRO” already appearing and innovation listed as the third-most-important consideration for sponsors considering outsourcing partners, it is likely the move toward social recruitment is already here. ²

References

1. Tufts CSDD Assessment of Cost to Develop and Win Marketing Approval for a New Drug Now Published. Tufts Center for the Study of Drug Development. 10 Mar. 2016. Web.
2. The 2016 Nice Insight Contract Research Organization Outsourcing Survey.
3. Shere, Mahvash, Xiu Yan Zhao, Gideon Koren. “The Role of Social Media in Recruiting for Clinical Trials in Pregnancy.” PLoS ONE 9.3 (2014). Web.
4. The 2015 Nice Insight Pharmaceutical and Biotechnology Outsourcing Survey.
5. Khatri, Chetan, Stephen J. Chapman, James Glasbey, Michael Kelly, Dmitri Nepogodiev, et al. “Social Media and Internet Driven Study Recruitment: Evaluating a New Model for Promoting Collaborator Engagement and Participation.” PLoS ONE 10.3 (2015). Web.
6. Lipset, Craig H. “Engage with Research Participants About Social Media.” Nature Medicine 20.3 (2014): 231. Web.
7. CISCRP The Centre for Information and Study on Clinical Research Participation. Web.