Site-Sponsor Relationship in Clinical Studies: Problems and Solutions

Site sustainability and the quality of site-sponsor relationship were major issues addressed at the 2016 Global Site Summit held by U.S.-based Society for Clinical Research Sites (SCRS) in Boca Raton, FL.

 

Information on 2016 SCRS Survey Respondents

Participating in the event were over 850 clinical study professionals, representing sites, clinical research organizations and sponsors from worldwide. President of the organization, Christine Pierre, presented the results of annual survey conducted by SCRS on various issues and trends in the industry.

The 2016 survey collected 463 responses from mostly USA-based sites (83%, with 72% of those respondents being SCRS members), all of them holding experience in clinical trials.

75% of respondents have been in the industry for 11 plus years, and over 40 % of them worked in a practice site. In 2015 alone 70% of those organizations conducted more than 11 clinical studies each.

 

Site Sustainability Factors                                        

The first issue addressed by 2016 SCRS survey was that of sustainability. The major difficulty mentioned by the majority of respondents in this area was the lack of study opportunities, followed by scarce human resources, cash flow problems and uncompensated activities. Mentioned among the top 6 factors were also pricing and challenges of recruitment.

Specified as the top three practices required for becoming a site of choice for partners were:

  • providing quality data;
  • enrolling eligible patients;
  • meeting timelines.

Maintenance of all three of these practices on a regular basis guarantees sponsors’ love. But in order to achieve such performance, the aforementioned six obstructions to sustainability first need to be removed or reduced.

It is obvious that sponsor-CRO-site relationships strongly want improvement. Among things that put strains into this relationship are steady increase of protocol complexity (beginning from the year 2000), site staff ROI, profit margin, and sites’ declining average per-patient-visit payment. Besides, a lot of partners keep on paying sites quarterly – actually, 60 % of sites are still being paid quarterly. Sites say that this practice impacts negatively study results. So, 80% of these organizations say that they prefer to be paid on monthly basis.

The majority of these issues can be improved in the conditions of true partnership with clinical research organizations and sponsors. 

 

How Partnerships Evolve?

The part of the survey asking about the quality of partnership with CROs and sponsors produced somewhat confusing results.

To the question, how their partnerships evolved over the last two years, responding sites gave the following answers:

  • partnership with sponsors: 31% of sites said they felt more like partners, while 29% felt less like partners;
  • partnership with clinical research organizations: 25% of sites felt like being more of a partner, with 39% feeling like being less of a partner.

Obviously sites’ partnering relationships with sponsors and clinical research organizations need to grow stronger. Remarkably, the majority of site respondents mentioned face-to-face meetings as the most preferred way of improving relationships. It is also the most preferred format for clinical trial trainings required by sponsors. This format is preferred over video and teleconference, as well as self-directed modules and paper-based trainings. One of additional advantages provided by face-to-face format is the opportunity for industry professionals to network.

 

How do Sponsors and CROs Feel About Sites?

Along with revealing some partnering related negatives, the survey also showed that sponsors and clinical research organizations do care about sites. This information was supported by the fact that sponsors and CROs had created departments to address their cooperation with sites, with over 25 titles (such as VP of site and patient network, or Director of site alliances) being held by industry professionals. These efforts prove that sponsors and clinical research organizations are interested in building reliable relationships with sites. These efforts demonstrate that the industry is listening to sites’ needs.

 

How to make Site-Sponsor Relationship Work Better for Both Sides?

What partners can do in terms of improving their own efficiency and relationship with sites, is strengthen their focus on customer service. It should be built into every site interaction – an observation voiced at Global Site Summit by VP of global operations for BMS, Peter Ronco. That customer service should consist of two key components: increased focus on flawless execution and site-facing staff. The flawless execution aspect implies having kits at the right time and in the right place, easy-to-use
EDC (electronic data capture) systems, inventory medicine and supplies, scanning and tracking technology, and study-in-a-box kits (containing everything needed for a patient during clinical trials).

Overall, most of the summit participants agreed that even with all the specified problems and difficulties, the clinical research industry is moving in the right direction, with relationships with major stakeholders evolving and improving. Significantly, any improvement in this area will ultimately lead to a better patient experience, improved experimental research practices, as well as better medicines reaching patients faster.