“Clinical trials have changed dramatically in the last decade,” said Cliff Echols, market intelligence director at SCORR Marketing. “More than ever, sponsors are pressured to get drugs to market faster and cheaper while addressing more FDA regulations, a growing number of trials, fierce competition for patients and an increasingly global trial landscape. In this survey, we dug deeper to understand how trials have changed and why. We also gained insight into what we can expect in the future as trials become increasingly complex.”

 

On the topic of complexity, the survey polled respondents as to what they thought best explains the trend of increasingly complex clinical trials. Many participants attributed this increase over the past 10 years primarily to a jump in the number of endpoints. In fact, “43 percent of academic institutions and 31 percent of project managers agreed that multiple endpoints best explain the increasing complexity of clinical trials.” CRO participants and clinical research associates/coordinators were less convinced, with only 13 and 11 percent, respectively, believing that to be the most likely cause. The second most popular answer for increased complexity, eligibility criteria, was popular among 43 percent of respondents from academic institutions and 42 percent of those from research sites. In looking ahead, most respondents indicated that they believe adaptive trials will be the key reason clinical trials become more complex over the next five years, with endpoints coming in second.

 

Answers were a bit more varied with regard to the question of how the patient-site landscape will change the most in the next five years, though the top three answers had only 7 percentage points of difference between them. The use of biomarker data for patient identification ranked as the top factor at 29 percent, while the use of electronic health records (EHRs) followed closely at 26 percent and direct-to-patient trials came in at 22 percent. The fourth most likely factor, clinical research as a care option (CRCO) was ranked at 19 percent. Interestingly, respondents’ answers to this question tended to depend largely on how long they’d been in the industry. For survey participants with one to 10 years of experience, CRCO and direct-to-patient trials tied as the most popular answer. For those with 11 to 20 years in the industry, the use of biomarker data for patient identification was the leading response, and for those with more than 20 years of experience, using electronic health records for patient identification is expected to cause the most change.

 

 Patient recruitment was studied as well, and the report notes that “The increase in social media usage has played a big part in the differences behind how clinical trial patients are recruited. Sixty-four percent of research site survey participants share this view, as do more than half of respondents from North America.” The launch of patient networks and advocacy groups was tagged as having the second biggest impact on patient recruitment for clinical trials, followed by increased competition for patients and more outsourcing to patient recruitment service companies. As for why site selection has altered, respondents attributed it foremost to increased competition for sites (56 percent) and the transition from site-centric to patient-centric models (28 percent).

 

Michael Tessalone, vice president/group publisher at Applied Clinical Trials, noted that “Among the key takeaways of the report is that respondents believe that some roles have changed more because of technology, while others are different because of increased collaboration. Data managers’ and clinical research associates’ jobs have changed because of technology, while project managers’ roles are different mostly because they must collaborate more across functions, respondents said.”

 

In terms of numbers, respondents attributed the change in clinical research associates’ jobs primarily to an increased reliance on technology and more risk-based monitoring (both tying at 33 percent), while data managers’ roles had also changed primarily due to greater use of technology (40 percent). The role of project managers has changed most because of more collaboration across functions, according to participants (38 percent), while regulatory affairs professionals’ altered jobs is attributed largely to having more regulations to keep track of (38 percent).

 

The survey report is available for free download at https://www.scorrmarketing.com/resources/clinical-trials-past-present-and-future-survey-report/