5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Newcastle-CCLG - Newcastle Children's Cancer and Leukaemia Pharmacology Studies Group |
|
| Evidence of collaboration with regulatory authorities | Yes | Members of the network have been involved in successful bids for FP7 projects relating to adapting off-patent medicines to the specific needs of paediatric populations, involving interaction with regulatory authorities (EMEA) in terms of study design. In addition, based on EC directive documents relating to the design of clinical trials in paediatric populations, studies have been carried out to investigate the issue of acceptable blood volumes and frequency of blood sampling in children participating in research studies (see 4.2). |
| Capacity to provide competent consultation to regulatory authorities | Yes | Members of the network have participated in EMEA meetings relating to the European Network of Paediatric Research in addition to being members of CCLG and SIOPEN committees as well as local ethics committees. |
| Formal meetings for clinical trials | Yes | Investigator meetings and initiation meetings with clinical centres. |
| Training courses given over the last 2 years | Yes | Training provided to research nurses at paediatric oncology clinical centres relating to study management, sample handling, data analysis and GCP issues. Training Day held in October, 2013, attended by 25 nurses from national clinical centres. |
| Training courses received over the last 2 years | Yes | Appropriate GCP training received by all staff and current competence maintained in compliance with sponsor requirements. |
| Promotion of participation in clinical trials in countries with limited resources | Yes | A study has been published involving patients recruited to clinical trials in Malawi and the UK (Israels et al., 2010). A collaborative paediatric oncology study has recently been initiated with the Tata Memorial Hospital in Mumbai, India. Support for these trials is provided by the reporting party. |
| List of Countries | Malawi, India. |