Case Study: Safety/Pharmacovigilance

Objectives

The objectives of the program are to: maintain a prospective representative database of the treated population during normal clinical practice, aimed to provide data on clinical safety, and closely monitor the usage of the product in the EEA countries, and monitor the use of the product in clinical practice.

Scope

Ongoing monitoring of events of special interest, SmPC compliance, benefit risk analysis of 8316 patients enrolled in 990 sites in Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Luxembourg, NL, Norway, Portugal addressing protocol and CRF design, regulatory support, Pre-selection, Study site initiation (Post & telephone), SRP management, EDC/Paper CRF design and production, site visits (ad hoc), data collection and entry, All AE/SAE handling and databasing, PSUR, descriptive statistical analyses.

Challenges

A key driving factor for the client was the need to collect CRF data using a hybrid system in all countries as required. Additionally this was not mandatory program in all countries, so the methodology had to be user friendly in order for unpaid physicians to be motivated to complete CRFs.

Solutions

Design: ability to collect data from CRF via hybrid solution and local office/language capability
EDC/Paper CRF hybrid:

1. Gave inexperienced treating physicians a choice of reporting thus increasing enrollment
2. Central AE monitoring with specialist medical support as AE data was the key data
3. Central website with stratified access by client
4. Local PAREXEL offices provided enquiry hotlines and local language follow up of CRF and AE queries
5. High level technical support and accountability at PD level (as requested by client)

Outcome

Delivered client and multi-lingual program needs within a flexible start up and program close schedule for each county.  Study closed, safety objectives met allowing client to make strategic decision on product life cycle.

Objectives

Study was being conducted as a label extension from Colorectal Cancer and now to Lung cancer. The data is to be used for publication purposes only.
Primary Objective: To assess the safety profile when combined with chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC.
Secondary Objective: To assess the efficacy as measured by time to disease progression and overall survival. To assess the safety in patients who develop central nervous system (CNS) metastases during and for 6 months following the treatment period.

Scope

Expose new future markets to the product for a new indication, make the study technologically innovative (via EDC) and collect additional safety data - approx. 2,000 patients currently enrolled in 45+ countries worldwide across more than 400 sites addressing Remote Monitoring, data management, stats, data entry, EDC, medical writing, PM services.

Challenges

Develop an effective working relationship between sponsor HQ and affiliates in over 40 countries, with tasks being split between PAREXEL, sponsor HQ and the affiliates.Convince investigator sites in several emerging markets that EDC was a viable option.

Solutions

1. Use of EDC enforced as a criteria for participation in the study
2. Sister Study approach (Lung & Breast studies)
3. Very high affiliate involvement
4. Both Lung & Breast studies would start up at the same time.

Outcome

Studies both ongoing – client feedback is very positive and another long-term safety surveillance study recently awarded with this client.

Objectives

Study to be conducted as a label extension from Colorectal Cancer and now to Breast cancer. The data is to be used for publication purposes only.
The primary objective: To assess the safety profile when combined with Taxane monotherapy or in combination as first line treatment of patients with LR or MBC.
Secondary objective: To assess the efficacy of when combined with Taxane monotherapy or in combination as first line treatment of patients with LR or MBC as measured by time to disease progression and overall survival. To assess the safety in patients who develop CNS metastases during and for 6 months following the treatment period.

Scope

Expose new future markets to the product for a new indication, make the study technologically innovative (via EDC) and collect additional safety data- approx. 2,000 patients currently enrolled in 45+ countries worldwide across more than 400 sites addressing Remote Monitoring, data management, stats, data entry. EDC, medical writer, PM services

Challenges

Develop an effective working relationship between sponsor HQ and affiliates in over 40 countries, with tasks being split between PAREXEL, sponsor HQ and the affiliates
Convince investigator sites in several emerging markets that EDC was a viable option.

Solutions

1. Use of EDC enforced as a criteria for participation in the study
2. Very high affiliate involvement
3. On site monitoring provided by affiliates

Outcome

Study ongoing – client feedback is very positive, and another long-term safety surveillance study recently awarded with this client.