Science and Technology CommitteeWritten evidence submitted by The Migraine Trust

1. The Migraine Trust is the health and medical research charity for migraine in the United Kingdom. We are committed to supporting people living with migraine by providing them and their families with evidence based information. We seek to raise migraine as a serious public health issue. The Migraine Trust funds and promotes research into migraine in order to better understand it, to improve diagnosis and treatment and ultimately to find a cure for this debilitating condition.

Migraine

2. Migraine is a complex condition with a wide variety of symptoms. For many people the main feature is a painful headache. Other symptoms include disturbed vision, sensitivity to light, sound and smells, feeling sick and vomiting. There are approximately eight million migraine sufferers in the UK and, there are an estimated 190,000 migraine attacks every day. One third of sufferers will experience significant disability as a result of their migraines at some stage of their lives. The World Health Organisation ranks migraine in the top 20 most disabling conditions, stating that a day with migraine is comparable to a day with dementia, quadriplegia and active psychosis. Treatment options exist for sufferers but there is no known cure for migraine.

Migraine Research and Clinical Trial Data

3. Despite the prevalence of the condition funding for research into migraine and headache worldwide is not prioritised. Migraine is the least publically funded neurological illness relative to its economic impact. In the UK very little clinical trial data is collected from sources other than pharmaceutical companies. This is because independent research bodies have not shown willingness to sponsor clinical trials in this area. The overall effect of these funding decisions is to reduce the likelihood of research developments changing the course of the condition for people with migraine.

How could the occurrence and results of clinical trials be made more open to scrutiny? Who should be responsible?

4. Openness and transparency of clinical trial data is essential to ensure that clinicians have access to the best data to make decisions about how to treat their patients. Greater transparency in clinical trials can be achieved by public sector part or full sponsorship. The involvement of public sector would necessitate greater scrutiny in the peer-review process which would mean more openness and rapid assessment. Funding streams provided by independent public bodies would ensure that smaller organisations could take responsibilities for clinical trials that may otherwise be unable to compete with large organisations.

5. Independent co-sponsorship could also be provided by charitable organisations. This can be facilitated by educational grants provided by the pharmaceutical industry which enables independent people to carry out the research. Strong and well regulated charity policies, for example requiring clinical trial registration and transparency of methodology, data and results would require the trial data to be more open to scrutiny. Strict regulations would be required to ensure that pharmaceutical companies adhere to the terms and conditions of the trials. Part of the educational grant could also be used for independent scientific research beyond the clinical trials.

6. This system could also be managed as “Research Deposit Fees” provided by pharmaceutical companies to fund independent research for each commercial led study that occurs. Monies could be returned on registration and open availability of the trial data by the pharmaceutical companies. This would allow funded research to occur and cash flow availability to the researchers independent of pharmaceutical companies. The allocation of these grants via public sector funding would ensure accountability and transparency and ensure trials were accountable to peer scrutiny.

7. Co-sponsorship and ownership of clinical trials is important to independent organisations such as charities as it enables these sponsors involvement in clinical trials who would otherwise be restricted by finances. Imposing this requirement on the pharmaceutical industry will lead to more openness and accountability of the system in the UK.

8. Statutory legislation to ensure that all parties adhere to the requirements of openness and transparency of clinical trials is required to effectively change the current system.

February 2013

Prepared 16th September 2013