Sponsors, CROs Doing Better, Sites Say, But More Work Is Needed
The ability of sponsors and CROs to meet the needs of their sites has improved slightly in recent years, according to a new CenterWatch survey, but sites say they need to see more progress in almost all aspects of their working relationships.
More than 4,000 sites responding to CenterWatch’s 2019 Global Site Relationship Survey rated the performance of the sponsors and CROs they work with on 37 to 40 key attributes. The respondents gave high marks to only about half of sponsors and CROs. The biggest problem areas for both groups were contracting and budgeting, the survey shows.
Sponsors’ average “excellent” rating rose 5 percent overall from 2017 — up to 53 percent in 2019 from 48 percent. CROs’ margin of improvement was narrower — 51 percent in 2019, up from 48% in 2017.
Sponsor and CRO attributes sites named as “very important” in 2019 remained largely the same as in 2017:
- Has professional, knowledgeable and well-trained monitors/CRAs;
- Is organized and prepared;
- Provides good overall protocol design;
- Staff is easily accessible;
- Offers timely drug availability;
- Maintains open communication;
- Sets realistic project timelines;
- Is responsive to inquiries;
- Has professional medical staff in clinical operations;
- Works effectively with sponsors/CROs; and
- Provides clear study initiation visit and training.
The attribute on which sponsors scored highest is “has professional medical staff,” with 55 percent of them rated “excellent.” Sponsors scored high on four other attributes — having well-trained CRAs, maintaining open communications, offering timely drug availability, and being organized and prepared — with 53 percent of sponsors receiving ratings of “excellent” on each.
Some of the lowest scores sponsors received were related to protocols. Only 39 percent of sponsors received a rating of “excellent” for actively soliciting feedback on the protocol design as well as actively engaging patients/patient groups in protocol design.
Forty percent of sponsors were rated “excellent” for flexibility and willingness to modify protocols. And 42 percent of sponsors received an “excellent” rating for providing protocols that require minimal amendments.
Survey respondents showed the most satisfaction with CROs in the area of overall project support, with 43 percent of CROs receiving a rating of “excellent.” Still, that number is down eight percentage points from the 2017 survey.
CROs’ handling of contracts and budgets consistently has received the lowest scores in recent years, but in 2019 fell to 37 percent after receiving a small boost in 2017 (44 percent) compared to 2015 (40 percent). In the specific attributes of prompt payment, realistic payment schedules and fair overall payment amounts, slightly more than one-third of CROs, 36 percent, received “excellent” ratings.
Only 37 percent of CROs were rated “excellent” for flexibility and willingness to modify protocols and budgets. And the same percent of CROs received an “excellent” rating for providing patient recruitment planning and implementation assistance.
Survey responses were submitted by investigators for 53 percent of sites, and study coordinators/nurses made up 34 percent of respondents.
Among sites responding to the survey, ratings by site type were fairly consistent, ranging from 52 percent to 59 percent of sponsors/CROs rated “excellent.” Ratings were gathered from independent research centers, private physician practices, academic medical centers, government-funded hospitals and clinics, and for-profit hospitals and clinics.
Independent research centers reported conducting the most industry-sponsored trials, approximately 12 per year with a total of 223 patients. For-profit hospitals followed with about nine trials per year and a total of about 118 patients. Academic medical centers conducted nine trials with a total of about 84 patients.
Looking at responses by region, sites in North America conduct about 14 trials per year with a total of almost 300 patients. In second place, African sites conduct about 10 trials per year with a total of 174 patients, edging out Asia Pacific with about nine trials and 86 patients.
European sites reported conducting about eight trials with a total of 90 patients, and South American sites about six trials with 89 patients.
Of all respondents in 2019, the number of sites conducting cardiology research was highest at 26 percent, followed by endocrinology at 25 percent and pulmonary diseases at 23 percent. Other therapeutic areas represented by this year’s respondents include:
- Rheumatology with 16 percent of respondents;
- Neurology with 14 percent;
- Gastroenterology with 13 percent;
- Pediatrics with 9 percent;
- Immunology and infectious diseases with 8 percent; and
- Oncology with 7 percent.
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