Clinical trials completed >12 months ago lacking summary results
Dear London School of Hygiene and Tropical Medicine,
please provide the following information:
1. How many of the clinical trials sponsored by the university that have been registered on WHO-approved primary registries have a primary completion date that is more than 12 months in the past? Please provide a list of all trials, including their corresponding registry trial number(s).
Please note that this information is NOT publicly available via trial registries as the university does not consistently maintain registry entries, as documented by a 2017 TranspariMED study:
https://www.transparimed.org/single-post...
Therefore, this question cannot be answered from publicly available sources.
2. How many of the trials identified in response to question (1) have not posted summary results on the registry/registries where they are registered? Please list these trials with their corresponding registry trial number(s).
3. How many of the trials identified in response to question (1) have not published their outcomes in academic journals? Please list these trials with their corresponding registry trial number(s).
4. Please indicate by what date the university plans to have posted the summary results for all trials identified in response to question (1) onto all registries where they have been registered.
5. Who within the university is responsible for ensuring that clinical trial results (a) get posted on registries, and (b) get published academically?
Please provide the information requested by Question 1-3 in Excel format if possible.
For the purposes of this FOI request, the definition of a clinical trial is that adopted by the WHO: "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials."
Background FYI:
https://www.transparimed.org/single-post...
https://www.transparimed.org/single-post...
https://www.transparimed.org/single-post...
https://docs.wixstatic.com/ugd/01f35d_de...
Yours faithfully,
Till Bruckner
Dear Ms Bruckner
Thank you for your request of 31 May 2018 for information under the Freedom of Information Act. We will process your request as soon as possible, and will respond by 28 June 2018.
Information on how we process Freedom of Information requests is available on the LSHTM website at : https://www.lshtm.ac.uk/aboutus/organisa...
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Please do not hesitate to contact me (email to [London School of Hygiene and Tropical Medicine request email]) if you have any questions relating to our processing of your request.
Best wishes
Victoria Cranna
Archivist & Records Manager
Library & Archives Service
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT UK
+44 (0)20 7927 2966
[email address]
www.lshtm.ac.uk/library/archives
Twitter: @LSHTMArchives
Dear Mr Bruckner
Thank you for your Freedom of Information request of 31st May 2018. The School does not routinely collect the information that you require so therefore does not hold this information. In any event, the cost of compiling the information you have requested would very likely exceed the appropriate limit applicable pursuant to section 12 of the Freedom of Information Act 2000, and specified under regulation 3 of the Freedom of Information and Data Protection (Appropriate Limit and Fees) Regulations 2004.
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Please do not hesitate to contact me (email to [London School of Hygiene and Tropical Medicine request email]) if you have any questions relating to our response to your request.
Yours sincerely
Victoria Cranna
Archivist & Records Manager
Library & Archives Service
London School of Hygiene & Tropical Medicine Keppel Street London WC1E 7HT UK
+44 (0)20 7927 2966
[email address]
www.lshtm.ac.uk/library/archives
Twitter: @LSHTMArchives
Dear Victoria Cranna,
thank you for your response.
You stated that: "The School does not routinely collect the information that you require so therefore does not hold this information. In any event, the cost of compiling the information you have requested would very likely exceed the appropriate limit applicable..."
I accept that this (disappointing) state of affairs explains your inability to respond to questions 1-4.
However, Question 5 does not refer to information collected by the university:
5. Who within the university is responsible for ensuring that clinical trial results (a) get posted on registries, and (b) get published academically?
Please do respond to Question 5.
Yours sincerely,
Till Bruckner
Dear Mr Bruckner
Apologies for not responding to Question 5 in the original response, the individual who can answer this question is on leave and back in the office on 12th July so we will respond after that date.
Best wishes
Victoria Cranna
Archivist & Records Manager
Library & Archives Service
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT UK
+44 (0)20 7927 2966
[email address]
www.lshtm.ac.uk/library/archives
Twitter: @LSHTMArchives
Dear Victoria Cranna,
thank you for the update. I look forward to hearing from you within the next two weeks.
Yours sincerely,
Till Bruckner
Dear Mr Bruckner
Apologies for the delay in getting back to you, here is the response to Question 5: Who within the university is responsible for ensuring that clinical trial results (a) get posted on registries, and (b) get published academically
It is the responsibility of each individual Project Investigator to ensure that clinical trial results get posted on registries and get published academically. PI's are offered support from the Research Governance Office in terms of training to do this but the office does not have the capacity to follow this up with each PI.
Best wishes
Victoria Cranna
Archivist & Records Manager
Library & Archives Service
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT UK
+44 (0)20 7927 2966
[email address]
www.lshtm.ac.uk/library/archives
Twitter: @LSHTMArchives
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