Central Nervous System

Challenging Patient Population

Sponsor :::

This study is sponsored by a biopharmaceutical company who is partnered with a fortune 500 company on the development of this study drug with a unique mechanism of action in Alzheimer's disease.

Project :::

A Phase 3 multi-center trial, 12 month safety and efficacy study evaluating an oral study medication in patients with mild to moderate Alzheimer's disease. Over 1000 patients enrolled across 120+ sites in 10 countries worldwide with approximately 60 sites in the United States. Patients will be followed for 12 months of study treatment and offered open label study drug at the end of that time for a period of at least one year after which minimal evaluations will be required and patients will be followed for safety.

Challenge :::

How do you ensure compliance and retention in a patient population that is dependent on caregiver assistance? This patient population has many obstacles to address when committing to a year-long study. Our experienced staff helps sites address those obstacles and find unique ways of helping patients and their caregivers comply with study visits and study requirements. For example, ProTrials has helped sites develop and implement tools for patients and caregivers such as visit reminders and compliance reminders; we have arranged for transportation to and from visits or reimbursement for transportation. Our monitors ensure that the sites have continual communication with their patients and caregivers to answer questions and remind them of their responsibilities. ProTrials has forged an excellent relationship with the Sponsor and works hand and hand with them to ensure study compliance and the completion of quality data.

Results :::

ProTrials has worked closely with each site to ensure optimal patient retention and compliance. If a patient is considering withdrawing from the study, we proactively work with the site to determine the reason for a possible withdrawal and in many instances are able to overcome those obstacles (e.g., transportation issues). If there are issues with dosing, we work with the site on ways to improve compliance (e.g., electronic pill reminder tools). ProTrials is available to sites at all times and we are able to provide the support that sites need to work closely with their patients.

In addition, ProTrials has completed four data-sweeps for this study in order for the DSMB to assess safety of the study drug and brought in 100% of required data fully monitored during that time. Our data monitoring and collection has remained above 93% for the duration of the study and our query rate has remained below 0.07% for the entire study. Our focus continues to be quality data, study compliance and maintaining excellent relationships with sites to ensure that both of these tasks can be met.

Sponsor Feedback :::

"We have worked with ProTrials for years across multiple programs and value their expertise, flexibility and responsive customer service. ProTrials' seasoned professionals have contributed both domestically and internationally, in-house and in the field, whatever our needs have been ProTrials has been our solution!"

-Sponsor, Sr. Director, Clinical Operations

Device Study

Challenging Protocol Logistics

Sponsor :::

A biopharmaceutical company engaged in the discovery, development and commercialization of transcription factor decoys.

Project :::

A Phase 3 combined drug/device rescue study in lower limb arterial bypass graft surgery, with 80 sites and over 1400 patients. The study was still enrolling when ProTrials assumed responsibility of this rescue study. Sites had been poorly trained on the protocol and use of the device, many sites were research naive, and data monitoring was significantly backlogged.

Challenge :::

How do you rapidly and effectively bring up the quality of the study while developing productive relationships with the sites? Many sites were research naive so GCP training by CRAs was required as quickly as possible. The investigational product was a drug/device combination and assembly and utilization was cumbersome in the surgical setting. Surgeons had received minimal training on the use of the device. Ten ProTrials CRAs and a single Project Manager were immediately assigned. ProTrials' highly experienced CRAs were well-equipped for the many challenging requirements of this project: conduct GCP training for site staff, receive training on assembly and administration of the device, and in-turn provide training to site staff, eliminate backlog of monitoring and ultimately beat monitoring goals.

Results :::

Sites were successfully trained
Data monitoring was completed 2 weeks ahead of schedule
Very low query rate despite high volume of data

Sponsor Feedback :::

"You have done a fantastic job turning this trial into a huge operational success...
It is through synergistic teamwork that complex tasks get accomplished in record time and you are an outstanding example of that...
The work load has been tremendous, the complexity and adversity high, and yet you have persevered, problem solved and progressed..."

-Sponsor Project Manager

Infectious Disease Study

Management of Highly Publicized and Controversial Study

Sponsor :::

A small spinoff from a global biotechnology company. The leadership team had a great deal of scientific and public health experience. Size of company at startup, six individuals.

Project :::

A Phase 3 Preventative HIV vaccine study. The first preventative HIV vaccine study to move into Phase 3. Goal was to rapidly enroll over 5000 subjects globally and follow them for five years. The Sponsor gave ProTrials the task of starting up and completely managing this trial through close-out and analysis.

Challenge :::

How do you successfully manage a controversial large-scale project from the ground up through the entire operational life-cycle? ProTrials effectively partnered with the sponsor during the early stages of the product's clinical development (Phase 2) and supported it for eight years through Phase 3 analysis. With the eyes of the public health world on this groundbreaking study, ProTrials participated in every aspect from study design, implementation, project management, subject recruitment activities, monitoring, and the development of critical subject retention strategies. We were able to appropriately staff the project with experienced and flexible staff to ensure that goals and milestones were met. ProTrials used exceptional communication skills and effective tools to adeptly handle the complexities of frequent press activities and highly public community relations associated with this study.

Results :::

Though the product failed to show efficacy, this project set the gold standard for trials in this area of prevention. The study model has been successfully utilized on several subsequent products. ProTrials continues to be dedicated to the prevention of infectious diseases.

Neurology Study

Rescue Study with Aggressive Timelines

Sponsor :::

A successful and growing pharmaceutical company partnered with a well known fortune 500 pharmaceutical company. It was critical to bring this study back on track to keep the partnership in good standing.

Project :::

A Phase 2 post herpetic neuralgia study. Previous CRO had monitored less than 50% of data in the initial 12 months, which was 6 months behind schedule. With just six months left in the timeline, the remaining data needed to be entered and monitored to meet the Database lock timelines.

Challenge :::

How do you collect and monitor more than half of the data with less than a one third of the study timeline remaining? As a result of low data quality ProTrials identified that all study coordinators required EDC re-training to ensure optimal data quality. Furthermore, we needed to develop a plan to reconcile and collect all required documentation, specimens and equipment prior to data lock. This required an experienced regional monitoring team that could hit the ground running immediately. In addition, it required a ProTrials Project Manager that could quickly organize, communicate, work well under pressure and effectively manage all activities required to bring this study to a successful closure.

Results :::

The first monitoring visit was conducted just 13 days after the kick-off meeting, and then 42 additional Monitoring Visits were conducted in approximately five and a half months. This resulted in the remaining 50% of the data being entered, monitored and cleaned in less than 6 months (as compared to the 12 months by the previous CRO). Thirty-four close-out visits were then completed in just 37 days.

Final queries were issued and resolved within three days, and the database was locked two days after eCRF sign-off. The original timelines for database lock were actually met one day early, and ProTrials was able to come in under budget for the successful completion of this important rescue study.

Oncology Study

Unexpected Interim Analysis

Sponsor :::

A biopharmaceutical company, partnered with a multinational pharmaceutical company, focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options.

Project :::

A Phase 3 multinational prostate cancer trial, enrolling 1200 patients worldwide, including 395 patients in North America.

Challenge :::

How do you rapidly adjust when the sponsor unexpectedly asks all vendors to prepare for an interim analysis and gives very short timelines for data collection? Fortunately, the ProTrials monitoring team was completely up to date on monitoring and data collection, which allowed our team to react quickly to the request. In addition, the team was resourced appropriately so we could be flexible and add additional site visits and communication time for queries as needed.

Results :::

ProTrials exceeded the database readiness goals by having an average of 98% of the data entered, 95% of the data monitored, and less than two queries per patient. By having the database clean, up to date, and the ability to react quickly, the ProTrials team ensured that at any moment the sponsor could conduct an analysis and be confident of the results!

Sponsor Feedback :::

-Sponsor, Sr. Director, Clinical Operations

Ophthalmology Study

Management of Multiple Phase 3 Trials

Sponsor :::

A world renowned leader in the biotechnology industry

Project :::

A Phase 3b ophthalmology study of an experimental treatment for Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) targeting up to 5,000 adult patients age 50 and above. ProTrials was contracted to initiate, manage and monitor this 145 center study. We were given two months from contract initiation to enroll the first patient.

Challenge :::

How do you rapidly scale up and effectively launch a large Phase 3b study in addition to managing two ongoing Phase 3 AMD studies for the same sponsor? ProTrials quickly developed a study management team that divided activities into digestible components. A Lead Project Manager was assigned to act as the primary contact with the Sponsor and direct the other managers on the team. A vendor manager was given the task of starting up and managing all associated vendors (e.g., central reading center). A regulatory site manager was given the task of managing all site-related and central IRB related documents and ensuring timelines were met. A Lead CRA was assigned to manage all site related questions, as well as all monitor related questions, and to post questions/answers in a centralized document. Lessons learned were shared across all three teams in a timely manner. Tools and processes were streamlined across all the teams to ensure consistency and efficiency.

Results :::

First patient was enrolled on schedule and the study was fully enrolled as planned. In addition, 313 extra patients were enrolled due to the popularity of the experimental treatment - all within eight months. The other two Phase 3 studies did not miss any goals or slip on timelines and remained on budget. These studies resulted in the successful BLA approval for this important AMD treatment.

Sponsor Feedback :::

"ProTrials did a phenomenal job staying on target throughout the project and was able to scale up quickly and efficiently during a challenging startup effort."

-Sponsor project manager.

Pediatric Study

Enrollment Challenge

Sponsor :::

A leading ophthalmic healthcare corporation.

Project :::

A Phase 4 pediatric study of two marketed treatments for pediatric blepharoconjunctivitis, targeting 136 pediatric patients under the age of six. Patient enrollment was three months behind schedule reaching only 50% completion after the first 17 months of enrollment. The Sponsor gave ProTrials seven months to complete enrollment for the study.

Challenge :::

How do you enroll half the patients in seven months when it took 17 months to enroll the first half? ProTrials determined quickly that study sites were not receiving site-specific recruitment support. Based on our experience, ProTrials immediately made the decision to assign one of our patient recruitment specialists to work closely with the sites to improve recruitment and retention efforts.

Our patient recruitment specialist quickly identified which sites had the greatest potential for enrollment. Focus was placed on this subset of sites and ProTrials rapidly provided them with recruitment ideas, materials and support. In addition to this subset of sites, all other sites were provided with ideas and support that made sense for their practice. ProTrials also assisted sites with developing pediatrician referral networks, organizing informational lunches and dinners, and creating study information flyers.

Results :::

The study was fully enrolled three months after we initiated our recruitment support - four months ahead of schedule.

Sponsor Feedback :::

'Completion four months ahead of schedule! This has been a great learning experience for all in recruitment initiative implementations.' -Sponsor Project Manager

Vaccine Study

Trial Under Government Scrutiny

Sponsor :::

A lead developer of vaccines to prevent and treat infectious diseases. Sponsor was developing an investigational second-generation smallpox vaccine and in parallel was manufacturing emergency-use stockpiles of this investigational vaccine for the US Government and other governments around the world.

Project :::

A Phase 2 dose-finding smallpox vaccine study in 600 healthy volunteers. Following the 9/11 attacks, this sponsor was awarded a government contract with National Institute of Allergy and Infectious Diseases (NIAID) to develop, manufacture and test a vaccine for use against potential bioterrorism. This vaccine development program was given Fast-track status by the FDA.

Challenge :::

How do you quickly start up, enroll and database lock a study that is under significant government scrutiny following a terrorist act? The expectations for expeditious service were significant. ProTrials had previously provided project management and study monitoring services to this sponsor on two studies investigating the first generation of this vaccine. This study was for a modified version of the vaccine previously worked on; the sponsor chose ProTrials for this large, fast-enrolling study because we were already familiar and experienced with the vaccine and its unique handling requirements. The study procedures and numerous sites were carried over from the earlier studies. We assigned the same project manager from the earlier vaccine trials, as well as assigning 10 regionally-based CRAs to ensure frequent and up to date site monitoring.

Results :::

Enrollment of 590 subjects was completed in four and a half months! The ProTrials team worked extremely quickly and closely with the site staff which resulted in meeting all timelines, including the database lock deadline.