IPWSO supports the undertaking of clinical trials including: pharmaceutical agents to treat specific aspects of PWS, such as trials of treatments for the initial failure to thrive, to improve social development and to reduce hyperphagia; and also trials of growth and sex hormone replacement and interventions, such as medical devices or psychological therapies, to treat problem behaviours. IPWSO recognises that properly conducted trials, the results of which are published in established peer-reviewed scientific journals, are a necessary part of developing and providing safe and effective treatments for people with PWS and we wish to see such new treatments become available to all people with PWS in the future.
This document has been prepared by the Clinical and Scientific Board of IPWSO and was considered by the Board of Trustees of IPWSO at their teleconference on 15th July 2019 and subsequently approved by the Board of Trustees on 19th August 2019.
This policy has been prepared in response to the fact that IPWSO receives requests from Pharmaceutical companies or from agents acting on their behalf to facilitate recruitment to clinical trials. IPWSO also receives support from Pharmaceutical companies towards its international conferences and other activities. The Board of Trustees of IPWSO therefore recognises that there is a risk that conflicts of interest may arise, actual or perceived, and that IPWSO may be unduly influenced, or perceived to be unduly influenced, by such sponsorship in the decisions it takes and in its subsequent actions with regards to their support for such trials.
This policy paper sets out the principles that govern IPWSO’s approach to pharmaceutical companies or other sponsors of trials.
IPWSO may choose to support requests for help for clinical trials providing the trial has the full approval of the necessary regulatory authorities and of ethical (IRB) committees and aims to evaluate treatment that may bring benefit to the health and/or wellbeing of people with PWS.
General principles include:
- IPWSO, as a charity registered in the UK, is bound by the relevant charity law and by European data protection legislation. Details of our members and of others, which are held by IPWSO, are private and would only be released and given to a third party with the consent of the organisation or person concerned.
- IPWSO will treat all applications to facilitate the undertaking of a clinical trial similarly and will not benefit or promote one trial over another due to IPWSO receiving any form of financial gain from one or other of the companies involved. IPWSO will, in no manner, be limited by any company in the support of trials by another company.
- IPWSO expects that potential participants with PWS and other relevant people (e.g., family members when children are involved) are fully informed prior to entering a trial and that appropriate consent procedures are followed at all times in accordance with the Declaration of Helsinki and other relevant conventions. People with PWS should not be under undue pressure to take part or be enticed to become a participant by promises, such as the provision of food.
- The fact that IPWSO, with the agreement of the relevant parties, introduce a Pharmaceutical company or other trial organisation to a national or local organisation that might aid recruitment to the trial should not in itself be interpreted as IPWSO endorsing the trial.
- The company concerned and the product being tested must meet the requirements of the regulatory authorities in the country concerned. It is these national (or international such as the European Medicines Agency) authorities who are responsible for such approval and it is for the company or those delegated by the company undertaking the trial and for those clinicians involved to ensure that these regulations are followed and that the trial is ethically and safely undertaken.
- IPWSO shall ensure that it does not incur any liability to any party conducting, participating in, or otherwise involved in any clinical trial and to the extent required shall only enter into any agreement relating to a clinical trial that contains appropriate wording excluding or (solely where agreed by the Board) limiting all liability of IPWSO in connection with that trial. Any introductions or recommendations of pharmaceutical companies, agencies or medical practitioners to any relevant parties for the purpose of or in connection with clinical trials shall contain a statement excluding any liability of IPWSO that may or does arise from that introduction or recommendation. Sample wording for such a statement is indicated below. “IPWSO does not promote any specific clinical trial and this introduction is made without any liability on the part of IPWSO to any person conducting or participating in any clinical trial.”
When receiving a request to facilitate the undertaking of a clinical trial IPWSO will:
- Seek the advice of the IPWSO Clinical and Scientific Advisory Board (CSAB) regarding whether the proposed is in line with accepted theories and that the company company concerned is known to have a sound reputation within the PWS research community. If necessary they will seek outside advice. The CSAB is not expected to make a detailed scientific evaluation of the trial as the trial will have received the necessary approvals from expert authorities and factors, such as risk, will have been evaluated. However, if any member of the CSAB had concerns he/she should report them to the Chair of the CSAB and to the IPWSO President who would be responsible for making any final decision.
- Depending on the nature of the request, the administrative officer of IPWSO will contact the appropriate individuals or those individuals representing national associations to ask if they wish to be put in contact with the proposing company and whether they consent to IPWSO passing on their contact details. For those who do not wish to be put in contact, no further action will be taken. For those who do, their contact details will be passed on to the company. The outcome of this will then be a matter between the company and the contact.
IPWSO may from time to time write commentaries for its website on trials that are either in progress or which have been completed and results published and peer reviewed. Such commentaries will be prepared by a suitably qualified and informed person on behalf of IPWSO and will be approved by the CSAB before being made public.
This policy will be kept available on our website and sent directly to all organisations seeking support with clinical trials, as well as to those to whom they are seeking introductions.
IPWSO was established so that PWS associations, families, clinicians and caregivers around the world could exchange information and support and have a united global voice under one umbrella.
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