Tag Archives: Social media

Study Design Improvements Have Positive Effects on Trial Performance

A recent impact report from the Tufts Center for the Study of Drug Development details how efforts to streamline clinical trial design appear to be yielding results [1]. Industry trial sponsors are using mechanisms such as facilitated review processes and adaptive trial designs to identify and address study feasibility issues, thereby reducing trial costs and administrative burden.

The center reviewed more than 20,000 procedures from recent phase 2 and 3 trials sponsored by 8 major pharmaceutical or biotechnology companies and conducted a survey with 83 industry executive respondents on experience with facilitated review processes.

Highlights from the analyses include the following:

  • 21% of procedures in phase 2 trials and 31% in phase 3 trials were for “non-core” data that did not support primary or key secondary outcomes
  • Non-core procedures accounted for, on average, one-quarter of a study budget
  • >90% of non-core data collected were included in clinical study reports and regulatory submissions
  • 21% of companies reported using simple adaptive trial designs to reduce costs and improve chances of study success; <10% reported using sophisticated adaptive designs
  • 76% of surveyed companies reported using facilitated review processes within the past 5 years
  • Many companies reported modest to major improvements in various measures of trial performance since implementing facilitated review processes (figure)
Figure: Percentage of companies reporting modest to major improvement in trial performance measures since implementing facilitated review processesPercentage of companies reporting modest to major improvement in trial performance measures since implementing facilitated review processes [1].

A discussion of social media perceptions with 20 pharmaceutical and biotechnology companies, as detailed in the report, further revealed that companies see potential value in soliciting stakeholder (e.g., investigators, patients) input on study design via social media. However, serious concerns regarding lack of regulatory guidance and potential for bias have kept companies from implementing this type of engagement to date.


1. Tufts Center for the Study of Drug Development. Protocol design optimization starting to improve study performance. Tufts CSDD Impact Report. 2014;16(5).

PCORI Executive Director Dr. Joe Selby to Speak on Regulatory Issues Concerning Big Data

The meeting of the Secretary’s Advisory Committee for Human Research Protections (SACHRP) scheduled for July 21-22, 2014, will include a session on “Regulatory Issues Concerning Big Data.” Joe Selby, MD, MPH, executive director of the Patient-Centered Outcomes Research Institute (PCORI), will speak, along with leaders from the NIH and FDA. The session is scheduled for 1:30-3:45 pm on Monday, July 21.

SACHRP provides recommendations on human subjects protection to the Secretary of the U.S. Department of Health and Human Services and reviews activities of the Office for Human Research Protections (OHRP). Other topics to be covered during the two-day meeting include informed consent comprehension, the return of research results to human subjects, and ethical/regulatory issues in interventional social media research.

The meeting is available to the public and will be videocast live.

View the meeting agenda
View the live webcast (available July 21-22, 2014)

A link to materials from the meeting will be provided in an update to this post when available.

Grand Rounds (3-21-2014): The Use of Social Media in Clinical Research


Archived video and slides  from the March 21 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

On Friday, March 21, the NIH Collaboratory and PCORnet Grand Rounds featured a presentation on “The Use of Social Media in Clinical Research” by Stephanie Startz, Associate Director of Digital Strategy for the Michael J. Fox Foundation. The Fox Foundation is a patient-focused nonprofit organization dedicated to finding a cure for Parkinson disease.

In December 2013, the Fox Foundation hosted a Twitter chat (#FoxChat) about challenges in clinical trial recruitment. The foundation’s blog notes that the discussion involved more than 90 participants and more than 600 tweets, making it one of Twitter’s hottest topics during that time. The Twitter chat, a full transcript of which is available online, engaged a diverse audience that included researchers, nonprofit organizations, patients, and patient advocacy groups, demonstrating that the Twitter chat format has the potential to elicit dialogue among these groups.

Ms Startz described the Fox Foundation’s other social media efforts on Facebook, Instagram, YouTube, etc, which have been successful in engaging the patient community and encouraging participation in clinical research. For example, a 3-day campaign on Facebook led to more than 1800 visitors to the Fox Trial Finder website. Advice for engaging patients via social media included being social by sharing stories and videos (not just requests for action), avoiding jargon, and responding to users. The Fox Foundation shares firsthand patient experiences, gives updates on trials, and thanks participants using social media. The Grand Rounds discussion covered issues of privacy and the extent to which social media could potentially play a role in involving patients in research design, not just research participation.