This year’s meeting continued to focus on two key themes impacting drug development, achieving successful Sponsor/CRO partnerships and leveraging the latest clinical technology solutions to advance drug development. The session notes below highlight the fundamental obstacles that remain, as well advances in these two central areas.

A session entitled, Taking the Pulse of Outsourcing: Relationships and Their Impact, included results from a recent study conducted by Tufts CSDD, presented by Ken Getz, director of Sponsored Research Programs & Research Associate Professor, Tufts CSDD, along with input from Fran Grote, senior director of clinical vendor management at Biogen.

While tremendous strides have been made within outsourcing partnerships, collaborations are still falling short of both Sponsor and CRO expectations. Key findings indicate sponsor companies varied the types of outsourcing relationship models used on a study-by-study basis. And, in no instance did sponsors consistently use a single CRO to manage relevant functional areas supporting a single Phase II or III study as intended.

The study also found that there are no statistically significant differences between relationship models across all but two performance and quality variables: integrated alliances had higher numbers of screen failure rates and lower frequencies of protocol amendments.

Barriers to realizing relationship potential occur across foundational factors in the areas of protocol design, site management, and patient engagement. Outsourcing practices are inconsistent, poorly executed, juggling legacy and new, and poor alignment with performance. Also, culture plays a big role in deterring potential with distrust, risk aversion, and commodity view of external providers.

Additionally, when it comes to innovation 79% of 112 sponsors think it’s their responsibility, yet only 41% consider their organizations innovative, and 68% feel that they’re not getting enough innovative ideas from CROs. On the other hand, 72% of CROs consider their organizations to be innovative, and 48% feel that sponsors are not open to innovative ideas proposed by their CRO partners.

With respect to CRO involvement in development planning and protocol, 14% of CROs report they have opportunities to regularly participate. CROs believe more than half of all study start protocol changes could be avoided if the CRO were involved in upfront planning and design.

A crucial component to moving forward lies within change management. According to Ms. Grote of Biogen, investment should be made in the process, not a point in time, and roles in both companies need to be redefined, with appropriate training, mentoring, tools and support. Also, communication must occur early and often and include varied modalities.

Not surprising, both sponsors and CROs felt the other can’t collaborate properly. To change the paradigm here, the issue mitigation process should not be based on escalation but proactive risk identification. Ms. Grote said, “think like a rescue in your planning phase.” Importantly, how you plan in advance for oversight vs. micro-management is key, using RACIs and an integrated team model, along with aligning performance goals are essential.

Finally, while sponsors are still somewhat reluctant to use CROs for more strategic activities, we know there has been a resource shift from sponsors to CROs. The best ways to utilize the resources of CROs is pipeline visibility and joint planning, along with shared goals. Often CROs can perform better with more information shared upfront from the sponsor.

Veeva’s 2015 Paperless TMF Survey
Technology has and continues to play a vital role in drug development. Advances in e-clinical solutions and progress towards paperless clinical trials are up and more clearly defined in Veeva’s 2015 Paperless TMF (Trial Master File) Survey.   

Over the past year, the use of paper has declined in key areas such as clinical operations, where those managing most TMF documents on paper is down 12% from 43% to 31%. Sponsors and CROs use less paper and fax to exchange TMF documents today than a year ago, with paper down 10% and fax down 12% from 47%.

One in four sponsors (24%) and CROs now utilize purpose-built eTMF applications to exchange documents, up from 15% in 2014. While more than half of respondents (59%) are electronically archiving documents, fewer have fully digitized other key activities such as e-signature (21%), document creation (25%), and collaboration (30%).

Further, those using purpose-built eTMF applications report improved audit and inspection readiness (61%) as a benefit of adoption more frequently than users of other types of eTMFs. Also, remote TMF access for auditors and inspectors is expected to double within the next two years to (65%). Lastly, the use of metrics remains limited, despite evidence that organizations extensively leveraging TMF data achieve greater benefits with their eTMF.

The top drivers of eTMF adoption include speeding study start-up (56%) and cost savings (53%), as well as improved audit and inspection readiness (45%). While the reasons for moving to an eTMF remain largely unchanged from a year ago, there’s a noticeable decline in the importance of improving monitoring (35% today vs. 49% in 2014). Better visibility into performance metrics is also a key driver for adopting an eTMF (41%), as these can provide insight into site adherence to study protocols and standard operating procedures (SOPs), which play an important role in optimizing monitoring resources.

According to the survey, the barriers to TMFs going paperless include: cost of technology and implementation (39%), limitation of in-house tools/technologies (36%), lack of  internal support (33%), regulatory requirements (25%), impact of organizational change (21%), and lack of interest/priority (18%).

Despite these barriers, we can expect to see further process improvement and removal of paper going forward. According to the survey, those using eTMF applications are more likely to report improved  inspection readiness, central monitoring, automated tracking and reporting, and better visibility into performance. Ultimately, these benefits are expected to shorten clinical development timelines.

Stay tuned for additional coverage from the 2015 DIA Meeting, including news, photos and videos.