Clinical Study Start-Ups: Reasons of Delays and Inefficiencies

Following the 2009 study of clinical trial start-ups, the Tufts Center completed a new one, based on responses from over 300 respondents at CROs and pharma companies.

To investigate the reasons for abundant delays and inefficiencies revealed by the first study, the new research focused on the processes of site identification and all the way through to site initiation, as well as on new technologies, approaches, and tools, along with other challenges and ways of overcoming them.

 

Site cycle time

The research on this aspect revealed the total length of end-to-end process of site identification and its initiation to be about 7 months – the same as it was nearly 10 years ago. It is distressing to see that the cycle hasn’t got any faster.

One of the reasons is the high number of new investigative sites – almost a third of the total number. Why wouldn’t CROs or sponsors continue with the sites they had previous good experience with? The explanation of this phenomenon is in the fact that clinical studies on orphan and rare diseases often require collaboration with investigators and sites the given sponsor have not interacted in the past. Protocols have also grown more complex, making it increasingly difficult to recruit patients who meet all criteria (inclusion/exclusion). Besides, there may be competition between companies for the same patients.

 

Non-activated sites

Another frustrating finding of the new research is that 11% of all sites never got activated because of failing to recruit a single patient. And this figure has not changed over the last 20 years even despite numerous new practices and technology solutions, and efficient personnel managing approaches.

What is more, the industry seems to have developed an acceptance of this fairly high threshold of inefficiency and agrees to this level of waste of effort and resources incurred by identifying, selecting and not activating the site.

The two most popular ways of dealing with this problem for CROs and sponsors are as follows:

  • Reactive: beginning with a specific number of sites and when some of them prove non-enrolling, proceeding with finding additional ones to substitute them. (Requires additional time and may result in clinical trials delay.)
  • Proactive: originally reaching out to more sites than needed for their clinical studies. (Increases the cost of the trial.)

 

Use of new tools and technologies in site management tasks

Another fact revealed by the recent research is that the available new tools and technologies are not used sufficiently and properly to provide for adequate efficiency of site management processes. As a result, the level of sponsors’ and CROs’ satisfaction with the processes remains as low as a decade ago.

So, the question is why sponsors and CROs do not adopt new technologies and tools to achieve improvement? The resent research showed that integration of new tools and instruments into organizations’ mainstream takes a long time, thus, rather than doing it, these companies prefer to test and pilot them only on individual clinical studies. However, it is also true that organizations’ greater investment in technology was rewarded by higher levels of satisfaction. Such initiatives as shared investigator database or tools replacing paper-based methods and spreadsheets have also proven efficient helping to cut down timelines. According to survey, another factor contributing to faster cycle time was usage of CROs, with their experience in the area being greater than that of their pharma counterparts.

Nonetheless, even though investments in the area of new technology and tools grow, it is not clear yet how pharma will adopt these technologies. And it is not the functionality or efficiency of the new tools that may fail, but rather the mindset of those in the industry who do not see this to be a pain point big enough to deserve investment and improvement.