Phase III COPD drug – U.S. and Canada

Challenge

Rescue one study that was behind in enrollment and prevent another related study from falling into rescue mode. The combined program goal for both studies was 1,110 patients across 200 sites.

Solution

ThreeWire initiated a comprehensive strategy including a recruitment program featuring newspaper, radio and television advertising across 35 markets. We also developed and launched a dedicated study website and patient portal with additional study information and reporting tools. Each advertisement was assigned a unique, toll-free telephone number so that we could measure and monitor the results down to each specific ad placement and medium. Calls to each ad were tracked, and the following week’s media buy was adjusted to maximize the overall response rate. Potential study participants had to pass stringent inclusion and exclusion criteria prior to being referred to the closest of 75 participating sites.

Results

More than 4,000 screenings were completed within three weeks, and the client’s recruitment goals were reached two weeks ahead of schedule which meant ThreeWire’s program saved our client time and money.

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Phase II arthritis drug – U.S. and Europe

Challenge

ThreeWire was hired to launch this project at a European investigator meeting just 10 days after the contract was signed. Our goal was to complete as many randomizations as possible in this 140-subject study while using only “known” patients (with extremely narrow inclusion criteria) from the sites’ referring physicians or existing databases.

Solution

ThreeWire quickly dispatched our medical personnel to conduct on-site chart reviews at selected sites in eastern and western Europe, the United Kingdom, Canada and the United States. In our experience, we have discovered that non-English speaking patients tend to respond better to "native-born" speakers so we hired highly specialized medical personnel for each language represented. Eligible candidates were contacted via telephone or letter and were offered the opportunity to screen for the study.

Results

Thousands of patient charts were reviewed to identify more than 300 potential participants. Approximately 180 patients were pre-qualified by our Patient Interaction Center® and 50 people were scheduled to be screened at a site. The sponsor was pleased that ThreeWire’s program had produced 35 patient randomizations in only 90 days.

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Phase III cardiology drug – U.S.

Challenge

The sponsor sought our help to "jump start" the U.S. portion of enrollment for this large international study so that their enrollment goals could be met before the deadline.

Solution

ThreeWire quickly designed and implemented a two-pronged strategic approach. First, our Site Services group worked closely with each site’s staff to conduct chart reviews that identified "known" study candidates. Eligible candidates were efficiently contacted and scheduled for screening. In our second, concurrent outreach strategy radio, television, print and web advertisements were employed to identify "unknown" study candidates who were then screened by our Patient Interaction Center®. Our Site Services group worked closely with staff at each participating site to ensure that eligible patients were efficiently referred to an appropriate site.

Results

Our first approach involved the on-site review of approximately 3,500 charts which produced 104 Patient Interaction Center pre-screenings. Eleven patients were referred to a site, and four of them became randomized patients.

Our media advertisements captured the interest of more than 3,000 potential patients who were then pre-screened by our Patient Interaction Center over a 30-day period. Approximately 400 of the pre-screened patients were referred to a study site and ultimately were qualified to become a group of 50 randomized patients.

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Phase II drug for Parkinson’s Disease – U.S.

Challenge

When the client approached us their enrollment for this 60-patient study had been underway for one year, yet only 35 subjects had enrolled. With the enrollment deadline a mere 90 days away, the sponsor challenged us to produce an additional 25 randomized subjects.

Solution

ThreeWire used chart reviews to identify a mix of "known" candidates and produced highly targeted radio and print advertisements to attract "unknown" study candidates. Our Patient Interaction Center® nurses screened the candidates, and those who qualified were invited to attend a ThreeWire Community Health Talk® (CHT®). This presentation featured an investigator who delivered additional information on the study and specifics of informed consent. If interested, attendees were offered the opportunity for additional screening at the site closest to them.

Results

Following a 30-day startup period, five Community Health Talks were conducted over a 10-day period. Of the 75 people who attended the talks, 25 of them were confirmed as randomized study participants prior to the 90-day deadline.

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