The meeting provided an update on the achievements and difficulties encountered toward the implementations of specific project tasks, the reasons for some delays and the mitigation strategies set into place in order to overcome such obstacles.

The meeting opened with an overview of the pharmaceutical company, Dompè, on the new liquid formulation specifications of Gabapentin as well as with a timeline for the drug production, setting the 3rd week of July as starting point, followed by packaging and final release from Quality Assurance.

Moreover, an update of the clinical studies has been provided, with a particular focus on:

• the description of the finalized GABA-1 protocol design, inclusion-exclusion criteria, study schedule, patient enrolment and eligibility criteria, study drug titration, optimization and end of study tapering;
• the description of the GABA-2 protocol highlighting the specificities of GABA-2 and the potential difficulties due to morphine handling and administration;
• the progression state of every Work Package (WP) and deliverables and a general update of GABA-3 study.

This meeting gave also the chance to discuss the main changes occurred in relation to the project plan and activities’ responsibilities.

The second meeting day provided an update on the GABA-1 Study management procedures, also including a full account about the informative consent set up for the study trials.

After presenting the web-based ICH-Good Clinical Practice Training Course, the organization of the trial infrastructure, that PHARM set in place for the management of GABA-1 and GABA-2, has been described. The meeting ended with the presentation of the e-CRF, created according to the study protocol in order to enable data to be systematically reviewed and analyzed, and a practical simulation on how data can be inserted in the e-CRF.

The meeting represented an excellent opportunity to foster fruitful scientific debates and to exchange information. Advancement in the work packages and partner involvements where discussed in order to build a perfect working basis for the forthcoming activities.

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CCI is the largest patient support organization for childhood cancer. It is a global, parent-driven non-profit association that represents 181 parent organizations, childhood cancer survivor associations, childhood cancer support groups, and cancer societies, in 90 countries, across 5 continents.

Representatives from European parent- and survivors- organisations as well as professionals from 24 European countries attended the event. In the context of the conference an introduction round on “CCI work & EU projects overview” has been organised on Friday 22nd of April 2016, where Patty Brouwer (CCI) presented the GAPP Project to this wide and receptive audience. After providing a general overview of the GAPP project, she explained the CCI role in the project explaining that: ”These trials will include many oncology patients. For their parents pain is one of the most concerning and frightening aspects of the journey. CCI wants to ensure that children receive the best possible care (pain treatment) wherever they are in the world at the time of diagnosis and beyond”.

She further presented the patient information material for both GABA-1 and GABA-2 trials composed of:

• 3 booklets for 3 age groups aimed to help children to decide in participation
• Video aimed to provide an explanation of trials in general
• Patient diary to be used by children and parents at home to record pain scores

She underlined that the information booklets have been reviewed by children in focus groups in Italy at the children’s hospital of Padova and in The Netherlands at the pain department Rotterdam and at VOKK (Vereniging Ouders, Kinderen en Kanker) patients association.

Here you can see the GAPP presentation entitled “Pain treatment in children. GAbapentin in Paediatric Pain (GAPP)”.

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The meeting provided an update on the achievements and difficulties encountered toward the implementations of specific project tasks, the reasons for some delays and the mitigation strategies set into place in order to overcome such obstacles, and dedicated specific session to the steps necessary for the implementation of the clinical studies.

With this specific aim, divided into six thematic sessions, the meeting allowed to address various aspects and issues of the gabapentin clinical development, such as protocols’ challenges and procedures, data management, clinical operations, dissemination and communication strategies as well as all the ethics and regulatory aspects.

The meeting represented an excellent opportunity to foster fruitful scientific debates and networking and to set project priorities. Indeed, it provided a great opportunity for exchanging information while discussing advancement in the work packages and partners’ involvement, in order to build up a perfect working basis for the forthcoming activities.

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The meeting was promoted in the framework of the EU-funded project DEEP (DEferiprone Evaluation in Paediatrics) and aimed to foster clinical research in Albania and raise attention on the importance of European Networks for the creation of synergies to spread excellence and attract European funding.

Structured into 2 thematic sessions (Clinical Research in Albania and Networks and Projects in a Global Context), the meeting provided the opportunity to discuss many topics related to the conduct of pediatric clinical trials, such as the barriers that researchers encounter to the timely development of safe and efficacious medicines especially for children; the related need to set up infrastructures for each study in each site; the role of collaborative efforts in medicine and research. In particular, participants stressed the importance of the international cooperation in the activities performed in clinical research as a way to promote interdisciplinary participation through high-impact, mission-driven collaborations with leading health providers, governments and educational institutions.

On this occasion, the GAPP Project was presented by Alketa Hoxha (University Hospital Center “Mother Teresa, Faculty of Technical Medical Sciences, University of Medicine Tirana, Albania), in the “Networks and projects in a global context” session with a presentation entitled “Participating in an international research network: the experience of Mother Teresa University Hospital in the GAPP Project”.

Here you can download the GAPP presentation.

For further information on the scientific events, please download the brochure of the event and the abstracts. Here you can download all the presentations of the Open Meeting.

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The “Nextwork” Forum represents a large-scale event where all project managers and dissemination leaders from European Member States and the neighbouring States can discuss about EU-funded projects by sharing opinions and evaluations with stakeholders and other interested people, thus creating a benchmark of awareness, perception, opinion and action.

The GAPP Project has been presented in the “Project – Best practice presentations” session and a dedicated page on the project was published on the Nextwork Forum official website.

The initiative was an important occasion to showcase the GAPP Project, compare experience at European level, create awareness in different audiences and develop international relations with the various protagonists of EU-funded projects (academic and educational institutions, universities, companies, public authorities, associations and research centres).

For further information on all the scientific events, please refer to the brochure of the event and visit the page where all EU projects are presented.

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The teaser video describes the scope and objectives of the project through the voice of scientists, patients and patient families, focusing on the prospects for an enhancement of the patients’ quality of life.

It includes touching moments resulting from the personal and direct experiences of children affected by chronic pain, who were interviewed last December in Athens with the collaboration of AGIA SOPHIA, reporting their situation, describing how their diseases are affecting their daily life and how they live with their pain.

The GAPP Project has entered in their homes and in their private lives, and it has given us the possibility to understand how we can really support them and how clinical studies can definitely help in finding a suitable cure.

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Representatives of the project leader, Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF, Bari, Italy) and project partners from 9 different European and non‐European countries gathered in the kick-off meeting to set the general organisation and communication basis of what is considered to be a scientific challenge within pharmacological research: finding a new drug and its appropriate dosage to improve the lives of children under 18 suffering from chronic pain.

In particular, GAPP aims to study gapapentin, a drug for which a great therapeutic interest has already been demonstrated, and make it available on the market in order to improve the quality of life in children with chronic pain, a widespread but poorly recognised problem that is in most cases treated with drugs which are not approved or used off-label.

Not only requiring high expectations from professionally dedicated clinical trials but also from a social and communication area, as the population to whom it is addressed, it’s a sensitive and vulnerable research subject; the project is seen, according to all involved parties’ statements, as a hopeful, revolutionary endeavor aiming to relieve young patients of one of health dire issues: chronic pain.

Through the development of two appropriately controlled clinical trials (GABA-1 e GABA-2), sponsored by Pharmaceutical Research Management Srl (PHARM), as decided during the General Assembly in June 2014, the project will investigate appropriate dosages, efficacy and safety of this drug in the treatment of paediatric pain. If the results of the studies lead to positive results, gabapentin will be able to respond to an unmet therapeutic need. PHARM is also the Applicant of the PIP (EMEA-001310-PIP01-12) submitted to the PDCO for the development of gabapentin in paediatric chronic pain with neuropathic component and will coordinate the clinical operations for the conduction of the two clinical trials. The new formulation of gabapentin for paediatric use will be developed, produced and distributed to participating clinical centres by Dompé SpA, one of the main biopharmaceutical industries in Italy, that will also coordinate the nonclinical development of the juvenile toxicity study.

The GAPP Kick-off Meeting press release entitled “EU FP7 GAPP – GAbapentin in Paediatric Pain Project Kick-off. Toward new therapies to challenge chronic pain in children”, was published on CORDIS – Community Research and Development Information Services (for a list of press releases please visit the dedicated Press Releases section of this website).

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Introducing the meeting, Prof. Ceci underlined the importance of the project in the context of European funding and paediatric research, while Dr. Aringhieri outlined that the GAPP Project is very challenging and Dompé will provide its contribution.

The GAPP non-clinical studies covered the topics of the first session, while two other sessions dealt exclusively with the implementation of the clinical study. A clear working framework for the project was provided by the appointment of the GAPP project bodies.

This first Project Assembly saw the appointment of the GAPP Project Scientific Committee as well as of the Scientific Coordination Body composed by the Chair Dr. Dick Tibboel, Dr. Laura Mangiarini, Dr. Mariagrazia Felisi, Dr. Rebecca Lundin, Dr. Tijtske Van der Zanden.

Dr. Donato Bonifazi, Managing Director of the Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) also informed the GA that the GAPP Ethics Board (EB), coordinated by CVBF through its Third Party Gianni Benzi Pharmacological Research Foundation (FGB), was appointed, with members Dr. Helen Sammons, Prof. Annagrazia Altavilla, Dr. Anouk Nijenhuis.

The post GAPP General Assembly appeared first on GAPP.

To this wide and receptive audience Patty Brouwer presented the GAPP Project, which final goal is to demonstrate the efficacy and safety of gabapentin both as monotherapy and as add-on therapy for the treatment of chronic pain, which affects children with various illnesses, including cancer.

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