Engage™


Accelerate your ongoing clinical studies.

Engage™

Accelerate your ongoing clinical studies. Only Engage delivers all of the following:

  • Rapidly identifies all issues hindering completion of your studies
  • Compares results from your studies with more than 200 successful studies
  • Delivers recommendations based on quantitative and qualitative input from your own investigators and coordinators

Engage™ dashboard identifies where to focus to get your trial back on track.

Month 6 (Example)
Category Ratings by Site Activity Level

Q. For the particular study you are answering about, please rate your level of agreement with the following statement: “There are issues with __________.”

Engage™ provides very granular information.
This example shows where there are problems
specific to ‘Setup, Training and Site Initiation’.

Issues specific to “Setup, Training and Site Initiation”

Q. You agreed there are issues with Setup, Training and Site Initiation. Please indicate ALL the reasons causing the issues.

Lacked training on ‘nuts
and bolts’ of the study

“At the investigator meeting they used
too much time on the theoretical parts
of the protocol and there was little left
for the day-to-day info that
coordinators rely on. ” ~PI
“I had some training I needed to do,
and the program that they do their
training through is not user-friendly.
We get a lot of error messages, not
able to print off certificates. “ ~SC
“Whoever did the presentation just
read straight from the slides. Very
monotonically. It was hard to stay
awake for however long he talked.” ~SC

Randomizing sites request better
promotional materials targeting the
right types of people.

Better Recruitment
Materials

“The recruitment material did not start for several months after the study had actually started. The brochures were not ready for several months after the study started. Then they were initially supplied in a very small number, and we had to wait to get more. Then it was done in sort of pulses, and not in a very continuous fashion.” ~PI
“Need more assistance to recruit the
correct type of subjects.” ~SC
“The support we received focused on
the wrong people.” ~SC

To help sites that randomized a study subject, revise the promotional materials to focus on the right types of subjects conveying the right messages

“Under the Radar” issues

“Under the Radar” refers to issues that have not attained
statistical significance but were mentioned often enough in
verbatim comments to merit acknowledgement in this report:
  • Documentation Burden
  • Eligibility: “3rd Line Only” Requirement

Documentation Burden is Excessive

Site staff mention hundreds of pages of poorly organized information that is difficult to sift through when they need answers quickly. The result is confusion, frustration and a sense that site staff are wasting their time. Issues such as this often reduce site engagement for the trial.

  • “Because there are hundreds of pages of materials to search through to find an answer and to ensure that we have all of the related information for a particular task, every action requires more time than expected.”
  • “The pages to read and review are a burden and it wastes my time.”
  • “I have never seen so much that my coordinators have to read.”
  • “Reduce the documentation burden.”

Engage™ Methodology


Engage™ provides the voices of site staff.
The advantages of Engage are:

  • Systematic collection of data
  • Results are compared with ‘successful’ trials
  • Rapid turnaround – results are provided within two weeks

Engage uses an internet survey that is:

  •  Validated
  • Available in 5 languages
  • Compared with normative data

Process:

  • Sponsor contacts sites
  • Clinical SCORE contacts sites
  • Site staff complete survey
  • Results are provided within two weeks

Analysis:

  •  Each respondent rates the degree 14 categories are issues at their site
  • When a respondent rates a category as an issue, they are shown issues relating to the category. A total of more than 120 issues are evaluated
  • Respondents provide open ended comments, which are evaluated

Typical Demographics:

  • Investigators and coordinators from XX out of XX total sites (XX%) participating in the XXX study completed an online survey.
    • XX investigators completed the survey
    • XX coordinators completed the survey
  • Country participation
    • USA – XX
    • – XX
  • Sites are participating in an average of XX trials.

Engage™ Budget


What is included is the following: :

  • Includes responses from up to 100 site staff (additional completed interviews is optional)
  • Draft email for use by sponsors to inform site staff that Clinical SCORE has been commissioned to conduct surveys regarding the trial
  • Clinical SCORE contacting site staff at least three times informing them of the project and their compensation (which is at fair market value).
  • Analysis of results: In addition to evaluating site level responses, the base price includes one of the following analyses:
    • By geographic distribution
    • By type of site (i.e., academic, non-academic hospital, large clinic, small clinic and dedicated research)
    • By status of site (e.g., active but not enrolled a patient, enrolled but not randomized a patient and have randomized a patient)
    • By medical specialty
    • By elapsed time from SIV
  • Up to two Web-based presentations

Available Options

  • Additional analyses are available – $1,500 per additional analysis
  • Up to 10 telephone interviews with site staff to clarify one or two issues can be obtained to clarify specific issues. Interviews will be scheduled with respondents identifying a specific issue when completing their internet survey. The incremental telephone interviews will be relatively brief, with a typical length of no more than 10 minutes. – $3,000 for up to 10 telephone interviews with targeted site staff
  • Additional completed interviews – $140 per PI and $100 per SC
  • Additional presentations – $2,000 per additional presentation

Engage™ keeps trials on track

Engage™ accelerates your ongoing clinical studies.

Only Engage delivers all of the following:

  • Rapidly identifies all issues hindering completion of your studies
  • Compares results from your studies with more than 200 successful studies
  • Delivers recommendations based on quantitative and qualitative input from your own investigators and coordinators