Care Bill [HL]

Debate between Baroness Wheeler and Lord Turnberg

Monday 10th June 2013 Lords Chamber

[Lord Turnberg]

My Lords, the point of Amendment 63, which is in my name, is the need for the HRA to emphasise transparency in the reporting of clinical trials because patients and the public must have confidence that research in which they have been involved will be used in the best way to spread the message for the good of other sufferers. They have to know that results, whether negative or positive, are published. As my noble friend Lord Warner has said, it is particularly important if they are negative, for at least two reasons. First, it is to stop the unnecessary, wasteful repetition of the research by others who are unaware that it has already been done. Equally important is to prevent a bias in reports towards research that shows only that a new drug works when other, unpublished, research shows that it does not. This is particularly important when we consider what is called meta-analysis, whereby an analysis is made of all relevant published reports, brought together to provide a large database on whether a drug works or does not. If only the positive results are reported, we have a biased result at the end, which could result in all sorts of problems.

Open access to research data provides researchers with a much better picture of their field than if research results are held too closely to the chest, perhaps by researchers jealous of their findings or by drug companies fearful of rivals gaining an advantage. It is heartening to know that GSK seems to have learnt the lesson: it is the first pharmaceutical company to lead the way in transparency. Members of the Association of Medical Research Charities make it a condition of their grants that results are published. We are pushing on an open door and we just need the HRA to have some capacity to ensure transparency in NHS research.

[Baroness Wheeler]

My Lords, I support Amendments 58 and 63. It is right for my noble friends Lord Warner and Lord Turnberg and the noble Lord, Lord Patel, to press the Government on this important issue. As we have heard, the Joint Committee proposed including the promotion of transparency in research and ensuring full publication of the results of research—consistent with the preservation of patient confidentiality—in the Bill and we strongly support this.

This is our first opportunity to welcome the establishment of the Health Research Authority as a statutory body and we do so wholeheartedly. We recognise the vital importance of research and innovation to the NHS, the very real progress that is being made in these areas and the scale and pace of change in medical science. The HRA’s objectives not only promote and protect the interests of patients and the public in health and social care research but ensure that it is ethical and safe research, which inspires the public confidence that my noble friend Lord Turnberg spoke about.



Alongside other bodies, the HRA has a key role in promoting transparency, and we acknowledge that its recent guidance on how it will undertake this role sets out important measures that will go some way towards underlining that it takes its duty seriously. These include: gaining approval from research ethics committees before clinical trials can go ahead; a new timescale for registrations; the commitment to work with research funders and sponsors to set the standards for the publication and dissemination of research outcomes; taking steps to facilitate further analysis of detailed data; and plans to look at how patient consent forms can be amended to provide early consent and understanding on how data will be used, as well as how the HRA will be informed of the outcome of study findings.

There is no doubt that the HRA is committed to working with others to overcome barriers to transparency and create a culture of openness. The amendment and Amendment 63, which provide for the publication of research findings “fairly and frankly” and transparency in the reporting of clinical trials, would enshrine the HRA’s commitment in statute, and ensure that clinical research benefits patients and that the findings are available for others to learn and benefit from. As we have heard from my noble friend Lord Turnberg, the advice of the Association of Medical Research Charities to its members to ensure that there is a requirement to publish in the terms and conditions of all their research awards has played an important role in providing greater transparency and would be reinforced by greater HRA authority in this matter.

Finally, like other noble Lords, I received a valuable briefing from the National Advisory Council to the Thalidomide Trust on the need for transparency and a change in the law for the disclosure of clinical and healthy volunteer trial data in relation to the drugs available on the market. The briefing states:

“Adverse effects caused by drugs that are designed to lead to a health improvement can be difficult to prove, and easy for the pharmaceutical companies to dismiss ... At the core of the problem is the fact that the safety assessments of a drug, undertaken in clinical trials done prior to the drug’s launch, remain hidden once the drug is on the market. A patient experiencing adverse effects therefore has no access to data that could be used to prove their claim … the onus is on patients to prove it was a drug that harmed them rather than the company that already holds that evidence”.

The Thalidomide Trust proposes changes to the informed consent form to allow sharing of anonymised data and making data from clinical trials available and accessible to the public once a drug has been released on the market. The trust acknowledges that this is a difficult issue. Have the Government had any discussions with the trust on this matter? I should be grateful if the noble Earl would comment on this, either today or in a written response.