An original way of using integrated data management and adjudication capabilities to ensure quality and consistency of the primary endpoint assessment was presented by PPM Services and Ethical. This end-to-end setup takes advantage of the complete integration between IVRS, EDC and eAdjudication in the Ethical cloud application and comes with minimal cost and resources requirements.
The GoalThe purpose of using an adjudication procedure is to ensure consistency and quality of the acne assessment across study sites. In case of high disagreement rate between local and central assessments a site may receive additional training (or even be closed) in order to preserve clinical data quality across the trial.
The Procedure
Once a patient is enrolled and data from the first visit are captured, regular photos taken with an iPad application are automatically loaded by the study site to a BOX location. From that point on, they are taken up by central staff, anonymized and moved to the eAdjudication platform where a central reviewer can access them and provide a blinded independent assessment of IGA. The system automatically compares scores and will alert on any disagreements between the two assessments allowing to correct possible misunderstandings or poor quality at the study site. The sponsor reserves the right to re-train and even close a site for poor compliance. The same exact procedure is followed at the final visit for each patient and will serve as a check of quality improvement. The whole procedure is light, highly automated and the two companies believe it will allow for a considerable improvement of quality at a minimal cost.
Study Protocol Summary of QC Procedure
1 - Patient Enrolment (with Ethical IWRS).
2 - First Visit (with Ethical e-CRF®): IGA first assessment performed at the site.
3 - Three photos captured with Apple iPad and transferred to each Site's BOX folder.
4 - Central Staff Controls Photo anonymization in BOX.
5 - Photos moved to eAdjudication® and submitted to Reviewers.
6 - Reviewers (blinded) repeats IGA Assessment.
7 - eAdjudication® detects and tracks disagreement (alert to CRO).
...
8- Final Visit (with Ethical e-CRF): IGA second and last assessment performed at the site.
… - steps from 3 to 7 repeated.
End-to-end data management with integrated quality control is made possible thanks to the flexible integration of Ethical’s eAdjudication and EDC tools.
PPM hopes to achieve higher quality and more robust clinical results by closely monitoring the consistency of the investigators’ assessment.
Mimmo Garibbo - Ethical Director: I'm proud about PPM Services choice. I'm sure the integrated work of Ethical Data Management Platform: IWRS, e-Crf, and eAdjudication® will contribute to the quality of this trial. This project is a further confirmation of the flexibility of eAdjudication Software to adapt to different Protocols needs and Adjudication Charters.
Salvatore Bellinvia - PPM Services Managing Director: I'm happy to partner with Ethical for this study with innovative use of Central Adjudication. This will be the first experience in Acne Drug Clinical Development. Our objective is to produce reliable and high-quality data on IGA score, primary end point requested by Regulatory Agencies. Ethical staff proved to be very responsive in understanding our Quality Control needs and to design a streamlined and integrated process based on their Clinical Data Management Software Solutions.
About Ethical
Ethical GmbH is an eClinical Company focused on Endpoint Adjudication with a cumulative experience of 300 international clinical trials, more than 10,000 investigator sites and hundreds of thousands of patients. Our solution was shaped around the idea of an Endpoint Adjudication Solution that is easy to implement and use. It provides out-of-the-box Endpoint Adjudication Software features in a Managed Service provisioning model that includes technical infrastructure, study configuration, training, and software validation management.
About PPM Services
PPM Services S.A. is the Swiss affiliate of Nogra Pharma Ltd.
Nogra Pharma Ltd is a private Biopharmaceutical company founded in 2005 and based in Dublin, Ireland, focused on the development of new therapeutic agents for the treatment of Immune-Mediated Inflammatory Diseases (Gastroenterology, Dermatology, Rheumatology, and Pneumology Therapeutical Field) from target validation up to either Proof of Concept clinical studies or up to MAA/NDA. The company has already had one successful product on the market for the treatment of ulcerative colitis, sold under the names Lialda in the US and Mezavant in Europe and elsewhere and which is marketed in partnership with Shire.
PPM Services is responsible for the Identification, Development, Regulatory Strategy and Quality Assurance of the Nogra Research Programs.
DOWNLOAD NOW THE ENDPOINT ADJUDICATION HANDBOOK
The Complete Manual / Reference Book with all the topics related to the Independent Endpoint Adjudication Committees Management
