A recent publication showed that in 100 sites participating in ongoing clinical trials:

Sites that used equipment incorrectly

91% of sites 91% 91%

Staff that were not trained in proper endpoint data collection

52% of staff 52% 52%

Staff that did not properly familiarize subjects with the test to be conducted

31% of staff 31% 31%

Is it any wonder why clinical trials fail?

Trials employing symptomatic or functional endpoints have experienced challenges with controlling endpoint variability and excessive placebo responses. Using lessons learned from over 25 years of clinical research, CPC Clinical Research has developed a proprietary program. EQuIP is a constellation of services we have developed to identify sources of data variability and intervene to minimize their impact.

EQuIP Endpoints

Treadmill Testing (ETT)

Ankle Brachial Index (ABI)

6-Minute Walk Test (6MWT)

Pulmonary Function Testing (PFT)

Wound Assessment

Transcutaneous pressurized oxygen (TcPO2)

The Right Design & Oversight

Choosing the right study design requires a full understanding of your development program objectives and specific study endpoints and their behavior in clinical trials. Ensuring that they are collected and adjudicated appropriately can make the difference between a successful trial and a failed trial. CPC brings worldwide Key Opinion Leaders (KOLs) and, decades of experience together to provide your trial with the scientific rigor and academic excellence you need for success. Services include:

  • Expert scientific oversight throughout the development program
  • Endpoint selection and protocol design
  • Committee staffing and/or management
  • Steering Committee
  • Entry Adjudication Committee
  • Endpoint Adjudication Committee
  • Data Monitoring Committee
  • Data and Safety Monitoring Committee

Standardizing Data Collection

Collecting endpoint data that involves active participation by the site staff and research subjects, requires rigorous quality control to determine the efficacy of your product. These same interactions inherently introduce variability. This standardization is an essential step in ensuring your endpoint is able to provide you with the answers you need.

CPC’s EQuIP addresses endpoint variability through:


  • Comprehensive identification of the causes of endpoint variability
  • Refining and standardizing procedures around data collection
  • Training all site staff on consistent and accurate data collection
  • Monitoring data quality and site performance in real-time

Site Quality Interventions: Site Endpoint Evaluation Visit (SEEV)

While standard monitoring visits focus primarily on source document verification, protocol deviations, drug inventory, recruiting, and enrollment issues, SEEVs go beyond traditional monitoring and into the specifics of endpoint collection, ensuring that every detail is standardized and controlled at each clinical site. The outcome is results with integrity, data with low variability and decreased placebo response creating a decisive development path. SEEVs provide detailed review of the data collection methods, procedures, and equipment. Clinical site staff perform mock procedures with specially trained CPC team members to ensure consistent elements in collecting the critical data, methodologies, attitudes, and practices of the site staff.

Core Labs

CPC Clinical Research has developed innovative endpoint core labs in many different areas (e.g., Treadmill Testing, 6-Minute Walk, Pulmonary Function Testing (PFT), Wound Assessment, and more). Our endpoint core labs provide central and standardized solutions for reviewing data collection methods, evaluating data quality, and providing expert data interpretation.

Site Quality Advisory (SQuAd) Committee

The SQuAd Committee convenes frequently and allows quick and consistent problem solving to the unique endpoint issues that inevitably arise during trials. This committee includes Dr. William Hiatt, other clinical scientists, CPC project KOLs, Project Managers, and the CRAs who are doing the hands-on review of the endpoint data. This committee provides thoughtful solutions for consistent correction of site errors producing a higher degree of endpoint data quality.

Endpoint and Disease Specific Training for Sponsors and External CROs

As the experts in reducing variability in endpoint data collection, CPC can enhance your team’s knowledge of both the disease under study and how to ensure it is measured accurately. In conjunction with our other EQuIP services, our hands-on training programs provide your project team, when that team involves non-CPC staff, with tools and information that allow them to help identify problems early in the trial. We work collaboratively with your team to ensure you have the best quality data possible at the conclusion of your trial. In addition to our endpoint and disease specific training, CPC has developed a series of general clinical trials training courses for newly-hired clinical staff that need to be immediately productive.

Independent Data Review

To ensure an unbiased evaluation and verification of the analysis, it is optimal to have clinical trial results reviewed by an independent, academic research organization. CPC provides the independent, third-party review for your trial results. These independent analyses are often required by the major journals for publication.

Publication

Publication is important to your trial and important to CPC. One of our initiatives is to make information from EQuIP available to the public in the form of publications.

Sponsors around the world have found the following benefits of using CPC's EQuIP services:

Controlled data variability results in smaller sample size and lower development costs.

Conclusive results for Sponsors to make clear development decisions.

Reduced placebo response and data variability.