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Disclosure UK: transparency should no longer be an optional extra

BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i3730 (Published 06 July 2016) Cite this as: BMJ 2016;354:i3730
Read all the latest BMJ articles on Disclosure UK and view the linked infographics here.

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Conflicts Of Interest management in an Italian Pediatric Ethics Committee

The letter by Andrea Messori and Roberta Rampazzo in response to Kate Adlington and Fiona Godlee editorial (Published on July 6, 2016) indicates a poor application of the principles of the Conflicts Of Interest (COI) disclosure at local level in Italy.
They report in fact that only 3 out of the 10 Regions answering their questionnaire have settled rules that obliges the Drugs and Therapeutic Committee members to periodically fill a COI form.
At our knowledge also the ethics committees (EC) for the evaluation of clinical trials, recently reorganized in preparation of the new European Regulation (Regulation EU n° 536/2014), apparently lack substantive initiatives for COI management. The European Regulation underlines (art.9) the need to auto-disclosure of any COI and highlights the financial features of the COI.
For this reason, in this letter we wish to point out the meritorious and compulsory activities of the Evaluation Committee of COI, established as part of the Pediatric Ethics Committee of the Tuscany Region to promote and manage this important issue.
The Tuscany Region has set up a Regional Pediatric Ethics Committee (CEP), following the Decree of February 8, 2013 on the reorganization of the Italian Ethics Committees, and based on the model the Pediatric Committee (PDCO) of the European Medicines Agency (EMA).
CEP evaluates all the pediatric clinical trials involving pediatric clinical centers of Tuscany.
According to the DM February 8, 2013 (art. 3) and the European Regulation n. 536/2014 on clinical trials of medicinal products (art. 9), the EC members should have no conflict of interest either direct or indirect and therefore each member should annually declare his/her COI. Somehow, the COI management is fully delegated to the correct behavior of the individual member.
Being aware of the delicate task of evaluating studies on such a vulnerable population, i.e. pediatric, where the so called no-profit trials are more than 60% of the studies, the CEP itself has decided, starting March 2016, to be supported by an independent commission (IC) in the process of COI management.
The IC evaluates the potential COI of any member of the CEP not only on the annual basis, but also before any single session.
This IC, set up by the CEO of Meyer Hospital, where the Scientific Technical Secretariat (STS) of the CEP is located, is chaired by an independent legal expert and includes a forensic scientist and a representative of the patients' associations.
Prior of the meeting of the CEP, the IC meets and evaluates the potential COI on the basis of the agenda and of the annual declarations of COI by the committee members. If the IC detects a potential COI for a member of the EC, the CEP is informed and, depending on the level of COI, the member is obliged to abstain from the evaluation process either completely or from the final part (approval).
The IC operates according to specific Standard Operative Procedure (SOP), developed by the STS and IC itself and highlights financial and other-type of COI, validating the auto-disclosed COI. The SOP is related to the procedures of the STS and CEP and it is included within the Quality Manual of the STS-CEP, approved by the "Quality Office" of the Meyer Children Hospital.
The annual disclosure form was developed according to that adopted the by 'International Committee of Medical Journal Editors’, but also refers to the Italian anti-corruption and transparency law with specific items for clinical trials. All these indications of transparency are published on the Meyer Children hospital website.
The IC has highlighted an incomplete filling in 40% of the declared annual forms asking for their proper reprocessing.
The main advantage of this system lies in raising the awareness on the issue of COI from a purely bureaucratic act to a necessary duty for every person involved in a clinical study.
While the process could be improved, the institution of an IC supporting the EC hopefully will increase the local attention to such a sensitive issue as the conflict of interest in an evaluation process of clinical trials.

Competing interests: No competing interests

17 July 2016
Alessandro Mugelli
President of the Pediatric Ethics Committee of the Tuscan Region
Leo Maria Carmela, Pharm D, Technical-scientific Secretariat of the Pediatric Ethics Committee, and De Masi Salvatore, Technical-scientific Secretariat of the Pediatric Ethics Committee
Department of Neuroscience, Drug Research and Child's Health (NeuroFarBa), Division of Pharmacology
University of Florence, Italy