Though some sponsors and CROs do hear and respond to site needs, the response rates are relatively low, and related changes are adopted by only a small number of site partners.
This means that the changes these exceptional sponsors and CROs make do not push the needle forward to an extensive and easily measurable degree overall. This does not mean that those sponsors and CROs who are committed to site sustainability do not have an impact on sites’ experience of working with them.
However, the site community needs to see more of their industry partners joining this effort and demonstrating a commitment to continued and improved partnership. The Clinical Research Sites (SCRS) Global Impact Partner (GIP) program is made up of sponsors, CROs and professional solution providers who have demonstrated their commitment to site sustainability, and our almost 10,000 member sites benefit greatly.
SCRS’ annual Site Landscape survey examines factors driving site success. This year, respondents indicated some changes in several key areas of site development and advancement, with small but promising forward movement. Nevertheless, an average of 46% of respondents noted no change in how sites are treated by sponsors and CROs today compared to two years ago.
There has been a significant push from SCRS and the site community to move to monthly payment terms, and more than 73% of site respondents noted that they try to negotiate a monthly rather than a bi-monthly or quarterly payment schedule for most CTAs signed. However, 44% of sites are still being paid on a quarterly basis.
Improvements have been seen as the percentage of sites reporting receiving monthly payment terms is at just over 38%, and with an equal 38% of respondents noting that when they do advocate for monthly payment terms, they receive them all or most of the time.
Most sites responded that compared to the previous year, communication with both sponsors and CROs have stayed the same. Similarly, most sites reported that compared to the previous year, sponsor and CRO response times for protocol issues have stayed the same, as have sponsor and CRO responses to requested budget edits.
Throughout 2018, the clinical research industry saw an increased emphasis on site quality. The number of capable sites continues to tighten, and these highly capable sites are being asked to perform more studies.
This puts these sites in a unique position to elevate themselves, but also increases pressure to perform well with an increased workload and little or no increased budget to support the extra work by expanding staffing.
A tremendous uptick in advancement and breakthroughs in genetic medicine in oncology was also seen in 2018. On November 26, the Federal Drug Administration (FDA) announced that it had granted accelerated approval to a treatment for oncology patients whose cancers have a particular biomarker – only the second time such an approval has been granted.
Recognizing the importance of these advancements, SCRS has planned its first Global Oncology Site Solutions Summit, which will take place February 2-3, 2019, in Austin, TX. This Summit is an important step forward, particularly in light of the recent loss of Christine Pierre, SCRS founder, and president, to ocular melanoma with metastasis to the liver.
In recognition of the importance and prevalence of oncology clinical research, Ms. Pierre was the thought leader who spearheaded the work to create an oncology-specific Summit, and now the conference moves forward in her honor and in recognition of the important work of oncology sites and the need to provide specialized educational and networking opportunities that support oncology research.
Finally, 2018 saw an increased emphasis on diversity in clinical trials. The FDA created the Drug Trials Snapshots in 2015 to provide the public with information about who participated in clinical trials that supported the FDA’s approval of new drugs. In 2016, the FDA Office of Women’s Health launched an initiative aimed at increasing the participation of women in clinical trials.
The initiative was launched in partnership with the NIH Office of Research on Women’s Health and targets older women, women from racial and ethnic minority groups, women with disabilities, and women with chronic health conditions. These and other initiatives to increase diverse patient recruitment have carried over into 2018 and promise to only gain momentum in the coming year.
In support of this increased emphasis, SCRS launched its diversity initiative in 2017 and published a research paper in 2018 that discusses how successful sites are at recruiting diverse patient populations for clinical studies. The paper examines the factors that drive site success (or a lack thereof) in diverse patient recruitment. It can be accessed here.
Focusing on site-centric movement, SCRS has advanced several projects in 2018 which founder Christine Pierre spearheaded. Best Site Practices (BSP) was developed in collaboration with the Association of Clinical Research Organizations (ACRO) and TransCelerate BioPharma.
The program provides sites with an outline of the critical elements necessary to start and sustain a clinical research site and an evaluation that measures site performance against multi-stakeholders’ expectations. Sites can receive a certificate that showcases their BSP score and use it to showcase their BSP results to demonstrate their commitment to quality.
As previously mentioned, part of what makes SCRS unique is its relationship with our GIPs. The I’m With SCRS initiative brings attention to each GIPs commitment and current level of involvement in important SCRS initiatives and allows GIPs to review their progress toward full-scale implementation of these initiatives.
In 2019, we expect that attention will remain focused on diverse patient recruitment, that there will be continued breakthroughs in genetic medicine, and that the emphasis on site quality will expand. In our commitment to the sustainability of the global clinical research site community, SCRS will continue to advocate on behalf of the sites.