Dear Imperial College London,

To build a picture of your adhesion to the EU registry requirements as part of ongoing research into university clinical trial transparency for UAEM, we have questions regarding your transparency on clinical trials.

Imperial College are currently being out performed by many other top UK research institutions in terms of published data on clinical trials. At present, only 31.6% of due trial results have been published. As students, we demand greater transparency from our university, considering the impact of, and trust in, Imperial's medical research worldwide.

1. Is trial 2010-023875-24 published anywhere?
2. Is trial 2010-021515-17 published anywhere?
3. Is trial 2009-017636-41 published anywhere?
4. Is trial 2004-000798-71 still ongoing?
5. Who is responsible for ensuring that Imperial College clinical trials are registered and published on time?
6. What is your process for cleaning up trial registry data?
7. When do you plan to have 100% of due clinical trial results published?

Yours faithfully,

Toby Pepperrell and Florence Rodgers
Representatives of UAEM Imperial College London

IMPFOI, Imperial College London

Dear Mr Pepperrell,

This is to acknowledge receipt of your request below, made under the Freedom of Information Act. The College aims to respond to your request within twenty working days of receipt of your request.

We will contact you again in due course.

Kind regards,
Catherine Harpham

dangos adrannau a ddyfynnir

Dear IMPFOI,

Your response to the freedom of information request is long overdue.

This information is important to review your clinical trial transparency, which could have massive implications for healthcare outcomes and access down the line.

Yours sincerely,

Toby Pepperrell

IMPFOI, Imperial College London

1 Atodiad

Dear Mr Pepperrell

Thank you for your recent Freedom of Information request. I apologise for the delay in responding to you.

Please find below the College's response to your questions.

1. Is trial 2010-023875-24 published anywhere?

No. This is because recruitment was too low to gain any useful results from this study. The results were presented to a group of ASCOT 10 investigators in an informal meeting, but were never published.

The study team now plan to combine the results with a larger morbidity study in the same ASCOT 10 cohort, using Hospital Episode Statistics (HES) data from NHS Digital.

The final papers will contain a mixture of HES data and questionnaire data from the regional ASCOT 10 study.

EudraCT is in the process of being updated.

2. Is trial 2010-021515-17 published anywhere?

Yes. Please see the following link: https://www.ncbi.nlm.nih.gov/m/pubmed/28...

EudraCT has now been updated for this study.

3. Is trial 2009-017636-41 published anywhere?

Yes. Please see the attached pdf.

4. Is trial 2004-000798-71 still ongoing?

No.

The trial ended in 2005 after 6 patients had been entered. Unfortunately the subsequent paper was not accepted by the journals it was submitted to, so the results were never published.

Please see an abstract of the study below.

Objective: To investigate the efficacy of Levetiracetam in reducing the degree of pendular nystagmus and oscillopsia.

Methods: Levetiracetam (max. dosage, 750 mg/day) and a placebo were compared using a double-blind, crossover design in 6 patients with acquired pendular nystagmus. Eye movement recording and a symptomatology questionnaire were used to measure the efficacy of the treatment.

Results: A marked reduction of mean eye velocity was obtained in 3 out of 6 patients. The patients that exhibited a marked improvement were able to identify the treatments before unblinding.

Interpretation: Levetiracetam should be considered for use as a symptomatic treatment for pendular nystagmus.

5. Who is responsible for ensuring that Imperial College clinical trials are registered and published on time?

Imperial College London guidance to Chief Investigators is that the trial’s results should be published on a public platform (i.e. clinicaltrials.gov or EudraCT) or in a journal within 12 months of end of study.

The College's Joint Research Compliance Office has further information about registering and publishing available here: https://www.imperial.ac.uk/joint-researc...
https://www.imperial.ac.uk/joint-researc...

6. What is your process for cleaning up trial registry data?

As advised above, oversight of updating trial registry data resides with Chief Investigators. The Joint Research Compliance Office supports the CIs and has issued reminders to report, and is currently working on a system of flagging up delayed reports.

7. When do you plan to have 100% of due clinical trial results published?

This is being worked on in line with the Health Research Authority mandate for reporting of clinical trials. The College is aiming for 100% compliance.

I am obliged, under the Freedom of Information Act, to inform you of our complaints procedures in case you are unhappy about the way in which your request has been dealt with. If you wish to complain about this response, you should contact the College Secretary at the address below.

The College Secretary
Imperial College London
Exhibition Road
London
SW7 2AZ
E-mail: [email address]

If you are unhappy about the way in which the College Secretary handles your complaint then you may have recourse to the official regulator for the Freedom of Information Act who is:

The Information Commissioner
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
http://www.ico.gov.uk

Kind regards,

Catherine Harpham

dangos adrannau a ddyfynnir