Recommendations

 

Strategies to manage interests

• Organisations and working groups involved in the development of guidelines and other resources should establish clearly defined and transparent processes for declaring and managing dualities and conflicts of interests.
  
• All researchers, academics, committees and people involved in such development should be required to make declarations of their dualities of interests, both pecuniary and non-pecuniary, and to give consideration to the potential influence of these dualities on the emerging products. This should occur at the outset of the development process and it should be revisited at every meeting.
  
• Where possible, the number of participants and authors with dualities or conflicts should be limited.
  
• Published materials should include rigorous documentation both of the process for managing dualities and conflicts and of the actual interests of participants, sufficient to demonstrate how the independence and integrity of the final guideline or resource was safeguarded. This may entail detailed annotations in relation to each part of the discussion explaining any relevant issues relating to interests and how they were managed.
  

 

Improvement of critical appraisal skills

• Researchers, ethics committees, clinicians, consumers, and newspaper and media journalists should undergo training in techniques for critically appraising clinical trial information.
  

 

Reform of regulatory requirements relating to new drugs

• Approval of new drugs should be subject to the criterion of ‘added value’, in addition to present requirements for proof of quality, effectiveness and safety, to ensure a therapeutic advantage over drugs already on the market.
  
• It should be a requirement that at least one of the two pivotal phase III randomised controlled trials should be carried out by an independent not-for-profit organisation.
  
• Pharmacological, toxicological and clinical trial data (appropriately de-identified) should be made freely available for scrutiny, preferably through publicly accessible trial registration websites.
  
• Regulatory authorities should be fully funded from public sources, independently of the industry they are meant to regulate.
  

 

Public funding of clinical trials

• Trials to answer important clinical questions without potential commercial benefit should be publicly funded. Such research would include trials to assess drug safety and effectiveness compared to existing best therapy, drug therapy in children and the elderly, non-drug therapies and orphan drugs used for rare and neglected diseases.
  
• Public funding for research could be largely derived from a levy on drug companies (e.g. a percentage of their marketing budget).
  
• All drug trial protocols and results should be publicly available to regulators, researchers, guideline developers and the public.
  
• Areas of unmet patient need should be identified and should receive priority public funding.