Monday, September 19, 2016

How Open Communication with Clinical Research Sites Will Improve Study Operations

by April Schultz, Content Marketing Writer, Forte Research Systems

Open Communication with Clinical Research Sites Can Improve Study Operations

Communication among stakeholders in the clinical research industry is integral to the success and improvement of clinical trial conduct. Though the industry continues to adopt new forms of technology to enhance communication between sites, sponsors, patients and more, many industry relationships are still hindered by miscommunication.

In particular, the relationship between sponsors and clinical research sites has historically been strained due to a consistent struggle to effectively communicate. With both parties juggling numerous studies and tasks at any given time, it’s difficult to address concerns in a timely manner and miscommunication is likely. The addition of a CRO extends the chain of communication between sponsors and sites, potentially exaggerating the struggle to relay information to appropriate individuals.

To alleviate this struggle, it’s important that both sites and sponsors actively maintain an open line of communication. One way sponsors can promote open communication is to encourage feedback from sites throughout the course of a study and after study closeout.
How to ask for feedback

At a recent conference, I participated in a group discussion focused on how sponsors can obtain feedback from clinical research sites. The group was comprised of representatives from all sides, with a fairly even distribution of sites, sponsors and CROs. The diversity of the group made for insightful discussion on what sites want sponsors to know about their day-to-day operations as well as the specific information sponsors want to gather from sites.

Initial talks focused on how best to approach sites for feedback on study communications. The group agreed that sponsors should address sites using one or more of the following methods:
  • - Face-to-face engagement
  • - Investigator meetings
  • - Email or direct messaging
  • - Online surveys
Necessary feedback

The conversation then turned to discuss the type of feedback that should be requested from sites. At this point, site representatives expressed their frustration with the extensive chain of people they are required to communicate with in order to relay information to the appropriate individuals. Some also mentioned their experience working with CROs, stating they don’t always feel adequately represented to sponsors and thus their needs are not always met. Sponsor representatives stressed that they want to be notified about a CRO’s performance so they can ensure their company is being positively represented. They also wish to gain a better understanding of ways they can improve the relay of information between all parties.

Overall, the group determined that sites should provide feedback on the following topics:


CRO performance
  • - How did the CRO represent the sponsor company?
  • - To what degree was the CRO able to speak intelligently about the study?
  • - Were you happy with the responsiveness of the CRO?
  • - Do you feel the sponsor and CRO were operating on the same page?
  • - Did you feel supported by your CRO?
Communication
  • - Were your communications responded to in a timely manner?
  • - Did the sponsor address your concerns?
Level of training and preparedness
  • - Did you have an adequate communication plan at the beginning, during and after the study? 
  • - Did you have an adequate escalation plan in place?
  • - Did you put those communication and/or escalation plans to use?
As a sponsor, gaining feedback from sites creates the potential for improved communication and could ultimately lead to more efficient study operations. 

To learn more about maintaining positive relationships between industry stakeholders through increased communication, read my recent article How Transparency Will Lead to Industry-Wide Collaboration in Clinical Research.

April Schultz is the Content Marketing Writer at Forte Research Systems, a developer of clinical research software. She is responsible for the creation and direction of Forte’s educational materials including blogs, eBooks and webinars. She manages Forte’s content calendar, oversees content posted to the Forte Clinical Research Blog and works with presenters to host Forte’s monthly educational webinar series.





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