Obesity/Weight Management

Metabolic/Obesity

A Phase II Placebo-Controlled, Randomized, Double Blind Study to Compare Antioxidant Levels in Normal Subjects with Elevated Waist Circumference When Administered One or Two XXX Capsules for Four Weeks.

Overview

The Sponsor was seeking a partner to provide CRO services to manage a Phase II study on near-metabolic Subjects and had a pre-defined budget and a time constraint. Their approach was to use multiple sites to ensure delivery of the necessary number of Subjects to power the study. They expected to recruit 120 Subjects to find 70 that would qualify for the study. The following services were required: protocol development, patient recruitment, site study conduct, lab services, Investigational Product (IP) packaging, monitoring, data management/statistics, and project management.

Challenge

Due to the Sponsor’s pre-defined budget and desire for a six-week enrollment period, the task was to maximize the study exposure to qualify enough Subjects to fill the cohort and minimize the costs associated with study conduct. In addition, the individuals sought as participants in this study were nearing metabolic. This is a difficult indication for individuals to self-identify.

Solution

Accelovance proposed utilizing one site – this would mitigate additional costs of monitoring and allow a focused approach to patient recruitment. Also, it would expedite the inclusion of other services, such as IRB approval; the setup of lab services; and packaging/delivery of the IP.

Rather than branding the study as a metabolic program, the patient recruitment team created an advertising campaign that focused on the individual’s waist size – something that is easier for people to identify. The campaign focused purchases in publications that overweight individuals were more apt to read.

Results

Over the course of four weeks, Accelovance prescreened 185 respondents over the telephone, screened 88 potential Subjects at the site and randomized 70 Subjects into the study. By having to only screen 88 Subjects at the site, and utilizing one research clinic, Accelovance was able to meet the sponsor’s budget requirement and beat its enrollment period.

Vaccine: Biodefense

Bio-Defense Vaccine

A Phase II Multi-Center, Partially Blind, Parallel-Group, Controlled Study of the Safety and Immunogenicity of XXX Vaccine Compared with XXX Vaccine in a Healthy Population.

Overview

As this was their first U.S.-based research study, the study Sponsor was seeking efficient and effective study conduct. They hired a large CRO to manage the project due to a critical 70-day reporting period that would provide data for their Phase III study design.

Challenge

The study Sponsor had selected a third-party patient recruitment firm to create and execute an advertising campaign at each of 17 clinical research sites. The third-party firm also managed a call center to deliver pre-qualified subjects to the research sites. After six weeks of utilizing this resource, the Accelovance sites saw limited subject flow, as a result of low call volumes to the third-party call center. In addition, many of the pre-qualified subjects did not meet some of the basic inclusion/exclusion criteria that were presented during the telephone screen.

Solution

The study Sponsor agreed to let Accelovance centrally manage the recruitment efforts for its own sites. Accelovance’s creative development team designed and implemented a new media campaign to re-brand the study and generate greater awareness in each of its markets. This campaign focused less on the vaccine itself and more on the benefits of bio-defense research. New media was purchased, and a centrally managed grass-roots campaign was created in each of the Accelovance cities to ensure market saturation.

Results

Almost immediately, the call volume nearly doubled, the screening at the sites increased, and the quality of potential subjects improved. Sites experiencing limited success suddenly became the high enrollers on the study. Eight Accelovance sites produced 149 of the 217 total subjects for the study (the other 68 subjects were enrolled by nine non-Accelovance sites). In addition, enrollment was closed three weeks earlier than originally planned. This allowed for the Day-70 data to be extracted from the sites earlier. Therefore the Sponsor’s reporting process began ahead of schedule.

Safety Program: Traveler’s Diarrhea

Traveler’s Diarrhea

A Randomized, Double-Blind Study Evaluating the Safety and Tolerability of a 600- mg QD Dose and a 600-mg BID Dose of XXXX Versus Placebo for XXXX in Volunteers.

Overview

Over the past year, the study Sponsor had experienced delays in conducting research on a preventative for traveler’s diarrhea. In an effort to attain internal corporate goals, the sponsor turned to Accelovance to conduct a safety study.

Challenge

Due to the difficulties that the Sponsor had experienced with other service providers, they imposed financial and time constraints to execute this study. There was additional pressure on the Sponsor’s clinical operations team to deliver results. Initially, the Sponsor selected Accelovance to deliver patient recruitment and study conduct services at several sites. Prior to study start, the Sponsor turned to Accelovance to provide additional services to augment their in-house clinical team, including project management, vendor management, and monitoring. This decision was made four weeks prior to site initiation.

Solution

Accelovance provided a project manager to the study who immediately galvanized the clinical team and prepared the research sites for study conduct. Utilizing seven of its sites, Accelovance created a strategic marketing campaign that raised awareness of the study during the year-end holidays.

Results

As study preparations began, the Sponsor transferred more and more responsibilities to the Accelovance CRO team. The team was able to garner IRB approval, initiate sites, and begin subject screening within seven weeks. Although two weeks of recruitment occurred during the year-end holidays, Accelovance sites maintained targeted recruitment timelines and delivered 660 Subjects over 10 weeks – ahead of Sponsor expectations.

Vaccine: Co-Administered

Co-Administered Flu Vaccine

A Phase IIIb, Randomized, Controlled, Open-Label, Multi-Center Study of XXX Absorbed Vaccine When Co-Administered with XXX in Subjects 19 Years of Age and Older.

Overview

The Sponsor requested four Accelovance sites to randomize 600 qualified Subjects in approximately two weeks just prior to the flu season.

Challenge

To meet timelines, the Sponsor required sites to randomize all Subjects within a two-week period. In addition, the Sponsor had not developed a recruiting campaign or recruiting materials.

Solution

Five weeks before the expected study start date, Accelovance created a strategic recruitment plan for our participating sites that included designing a media campaign, creating the associated collateral, gaining IRB approval, executing media purchases, and deploying the Accelovance call center. This plan was executed and evaluated on a daily basis to ensure success.

Results

The study began in October, on the verge of the 2006 flu season. Accelovance was responsible for delivering 592 randomized Subjects within an approximately two-week competitive enrollment period. Starting patient pooling efforts nearly four weeks prior to study start, Accelovance had identified nearly 700 interested and qualified potential Subjects for the study. Sites scheduled 20 subjects per clinic day to meet the Sponsor’s timeline. Accelovance met the randomization goal of 600 Subjects in two weeks and was requested by the Sponsor to continue enrolling up to 79 additional patients. Over-enrollment at Accelovance’s high producing sites will help the study meet its overall enrollment and randomization timelines.

Cold & Flu Prevention

Probiotic Cold / Flu

A Placebo Controlled, Randomized, Double Blind Pilot Study to Evaluate the Use of XXXX for the Prevention of Cold and Influenza

Overview

The study sponsor, a repeat Accelovance customer, made a determination late in the flu season to conduct a study to determine if their fruit extract could mitigate or altogether eliminate the symptoms of flu and cold. In order to expedite the execution of this study, the sponsor hired Accelovance to provide a full service solution as the CRO, sites and patient recruitment team.

Challenge

There were three challenges facing the Accelovance team in conducting this study:

Timing – Accelovance was contracted in early October to execute this program that needed to randomize Subjects prior to the expected year-end onset of flu season.

Recruiting – In order to effectively satisfy the statistical modeling, Accelovance had to recruit an enriched population – those that would be more prone to be exposed to cold/flu. In addition, those recruited had to be flu shot naïve for the upcoming flu season, and be between the ages of 18 and 49. Finally, the study sponsor requested that a focus on educators would be in line with their corporate goals – a target of 80% teacher participation was set.

Investigational Product – The study sponsor managed the production and distribution of the investigational product for this study. In an effort to produce quantities necessary for this study, manufacturing issues caused the study enrollment to stop twice.

Solution

Accelovance put together a team that handled all sponsor needs: project management, protocol development, site management, patient recruitment, lab services, monitoring, data management and statistics. In order to meet the startup requirements and enrollment timelines, Accelovance quickly converted the proposed protocol synopsis into a full protocol for submission to a central IRB. During this time, Accelovance worked with the IRB to insure that the final submission would provide all details and information necessary for fast-track approval.

Accelovance utilized six sites that had the capacity and time to access the teaching population through a grassroots campaign. The patient recruitment team targeted teachers at their place of work, through direct mail and word of mouth marketing. A referral program encouraged interested teachers to tell their colleagues about the study.

Results

Timing – The Accelovance team was able to go from protocol synopsis to first patient randomized in 6 weeks.

Recruiting - Prior to study start, Accelovance had successfully identified and qualified over 300 participants. 420 Subjects were screened into the study in 3 weeks. In the end, 80% of randomized Subjects were teachers.

Investigational Product - Enrollment was halted for two weeks due to IP issues, then restarted and delayed for another 4 weeks for similar reasons. After a total of 6 weeks of study hold and the holiday season, Accelovance was able to retain 98% of study participants for reenrollment into the program. In the end, Accelovance enrolled 420 Subjects in a combined time frame of 5.5 weeks, 2.5 weeks ahead of originally planned.

Vaccine: Combination

Booster Vaccine

A Phase IIIb, Prospective, Double-Blind, Randomized, Controlled Multi-Center Study to Evaluate Immunogenicity and Safety of Sponsor’s Vaccine Combination, Absorbed XXX Compared to Marketed Combination Vaccine, Absorbed XXX, when Administered in Adults 19 to 64 Years of Age.

Overview

The study Sponsor was eager to enroll this study, as this was one of many in their pipeline. Their past experience dictated that delays were inevitable, and to combat this, they decided to initiate over 50 sites to enroll 2,250 study subjects; included were six Accelovance sites scheduled to enroll 400 Subjects in 12 weeks.

Challenge

The Sponsor had not developed a recruiting campaign or recruiting materials and was uncertain of the actual enrollment start date due to manufacturing delays.

Solution

Six weeks before the expected study start date, Accelovance created a strategic recruitment plan for our participating sites that included designing a media campaign, creating the associated collateral, executing media purchases, and deploying the Accelovance call center. In addition to utilizing media, Accelovance’s community-driven marketing efforts and patient referral program motivated existing study Subjects to refer their friends and family. This plan was executed and evaluated on a daily basis to ensure success. The patient recruitment team also adjusted the mix of media in some sites to include television and radio in order to broaden its reach.

Results

Over the course of four weeks, the Accelovance sites had created a patient pool of 782 potential Subjects to enroll in the study. After study drug shipment delays were resolved, the Accelovance sites randomized 630 subjects in 15 business days. The average Accelovance site randomized 79 subjects, while the average study site randomized 36 subjects. The enrollment period for this study was reduced from an expected 12 weeks to four weeks. In addition, Accelovance sites maintained a 94.2% subject retention rate.