Therapeutic Area: Pulmonary/Respiratory Disease

Ailment: Asthma

Client Objective

Stimulate pre-qualified, measurable responses to ensure meeting randomized patient goal within the 120 days remaining in the study.

Study Background

End-of-study site fatigue and personnel turnover had created gaps in the recruitment efforts study-wide. The time of year, June through September, posed response challenges because of the summer season. A plan was needed to allow a household to respond at their leisure while meeting our timing needs.

Campaign Strategy

• Develop and implement a site-evaluation program to gauge the interest and ability of the current sites to participate in an accelerated recruitment effort.
• Develop and implement a “Site Enhancement” program to educate and generate excitement for the accelerated campaign.
• Develop a direct-to-household mailing campaign to pre-qualified, opt-in subjects within a specific geographic radius of the site. These pre-qualified, opt-in households have a higher propensity to not only respond, but complete the enrollment process.
• Utilizing an Axiom centralized web/interactive voice response system (IVRS) to track and screen responses, the qualified leads were forwarded to the sites every morning for follow-up.

Results Summary

Criteria	Outcome
Total Number of IVRS Responses	1,038
Total Number of Web Responses	484
Total Number of Qualified Responses	667
Total Number of Unqualified (screened) Responses	734
Total Number of Randomized	24
Total Number of Screen Failures	478
Total Number of Qualified Respondents Unaccounted for	167
* Start Date June 2; First Mailing July 5; Last Mailing Sept. 5
Total Selected Sites (of 75 possible)	42
Total Mailed	166,000
Statistics
Total Responses	1,522
Response Rate	1%
Qualified Responses	44%
Randomized Rate	4%
Qualifieds Unaccounted for at Closure	11%

 

Therapeutic Area: Neurology/Central Nervous System

Ailment: Bipolar Disorder (with Heavy Alcohol Use)

Client Objective

Develop a pilot program to test direct-to-subject methods for responsiveness and pre-qualification screening of this unique, dual-diagnosis population.

Campaign Strategy

• Compile a database and develop a pre-qualified, opt-in, direct-to-household mailing campaign to a specific geographic radius of the site.
• These pre-qualified, opt-in households have a higher propensity to not only respond, but complete the enrollment process.
• Utilizing IVRS (Interactive Voice Response System) and
  web methodologies to pre-qualify and refer subjects to the corresponding sites. The Study Team had real-time reporting capabilities to monitor the results.

Results Summary

Criteria	Outcome
Unique Visits to the Web Site	147
Phone Responses (IVRS)	231
Total Contacts	378
Net Pre-qualified Subjects sent to the Investigative Sites	81

 

Therapeutic Area: Neurology/Central Nervous System

Ailment: Pediatric Bipolar Disorder

Client Objective

Stimulate awareness of this branded study to reinforce and stimulate the sites activities in the screening and referral of pre-qualified subjects for this trial at the site level.

Study Background

This difficult-to-reach patient population required educating not only caregivers but medical professionals and the community about the often misdiagnosed ailment of adolescent bipolar disorder.

Campaign Strategy

Customize a 12-month initiative, from the investigator site market perspective, through the interface of team members to identify individual and geographic opportunities unique to each of the 35 markets/sites.

A three-tier approach was identified by the Team for this recruitment initiative:

• Medical/Educational Referring/Awareness Initiative
• Community Awareness/Public Relations Program
• Investigator Community Outreach and Site Fulfillment

Additional program elements provided by Axiom:

• Development, implementation and maintenance of the study-branded web site
• Development, implementation and maintenance of the study virtual/live call center
• Coordination and production of bilingual informational brochures and posters

Results Summary

Criteria	Outcome
Unique Web Responses	837
Phone Responses (IVRS)	583
Total Contacts	1,420
Net Pre-qualified Subjects sent to Investigative Sites	181

 

Therapeutic Area: Rheumatology

Ailment: Rheumatoid Arthritis

Client Objective

Stimulate screenings to ensure meeting ‘last patient in’ date which was only eight weeks away.

Study Background

Centralized recruitment initiatives through print and broadcast had generated a large volume of calls from unqualified subjects, putting an extreme burden on the site personnel.

Campaign Strategy

• Develop a direct-to-household mailing campaign to pre-qualified, opt-in subjects within a specific geographic radius of the site.
• The pre-qualified, opt-in households have a higher propensity to not only respond, but complete the enrollment process.

Results Summary

The number of screened, qualified individuals was reached within a
five-week period which allowed the study to be completed as planned
with site satisfaction.

Specifics
Sites	18 US markets
Total Households Contacted	178,303
Timing	January and February

 

Therapeutic Area: Neurology/Central Nervous System

Ailment: Adult Bipolar Disorder (Depression/Mania)

Client Objective

Stimulate awareness and recruitment for this branded dual study, needing approximately 95 sites to recruit/enroll over 500 patients between the two trials.

Study Background

This difficult to recruit patient population required a unique strategy of education, awareness and direct-to-subject methodologies. The sponsor anticipated that 50% of the participating sites would “opt-in” to participate in this recruitment initiative.

Campaign Strategy

Maximize site participation in a three-tiered recruitment strategy, designed with input from the sponsor and site focus group input over a twelve-month period.

The initiative consisted of:

• Medical/Educational Referring/Awareness Mailings
• Community Outreach/Public Relations Program
• Television Advertising (customized site-based “On-Demand” ads, as well as a focused centralized campaign)

Additional program elements included:

• Development, implementation and maintenance of a study-branded web site and a study virtual/live call center
• Development, production and distribution of study-specific patient and professional brochures, posters and referral pads
• Investigator meeting participation
• Study Team Web Site with metrics.

For an example, click here.

Results Summary

Over 95% of the sites opted-in to participate when only 50% participation was expected in this recruitment initiative. Additionally, the Axiom strategy resulted in over 2000 unique qualified responses that helped the sponsor enroll the necessary amount of patients earlier than expected, resulting in the closure of each study more than three months ahead of schedule.