How transparent are LEO Pharma’s clinical trials?

LEO Pharma

Registration 200/500
(40%)
Summary results 375/500
(75%)
Clinical study reports 250/500
(50%)
Individual patient data 205/500
(41%)

Transparency rank

2nd

Est. sales (USD)

$1.5bn

Known for

Picato gel, Xamiol, Daivobet/Dovobet/Taclonex

The results of clinical trials are routinely and legally withheld from doctors, researchers, and patients. We have assessed every company’s policy on clinical trials transparency to see whether they meet a series of standard transparency criteria, and checked our findings with the companies. We have then applied a score to each commitment, and used these to rank the companies. You can see all our raw data, and review our methods, on this site.

Below, you can read in more detail about the specific commitments made by this company on each of the four domains: registration, summary results, CSRs, and IPD.

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Registration

Why Registration is important

Before a trial is started, it should be “registered”: a description of the trial is posted on a publicly accessible trial registry, recognised by the World Health Organisation. This means that everyone knows the trial is happening, and will know if it is left unreported. It also helps readers detect if the trial has been designed, analysed, and reported correctly. This graph shows how LEO Pharma’s policy on registration compares to others’.

Measures

We assess every company’s policy by reading through their commitments, and checking off whether they meet a range of criteria. We send every company our assessment, then apply a scoring system to each element. You can read about the scoring system here. You can read our detailed assessment of whether LEO Pharma meets each of our criteria, below.

registration_1: Do they have a policy to register all trials (excepting specific exclusions in later columns) from now?
Yes
registration_2: Do they say they conduct any kind of audit of compliance with their registration policy? (If they don't mention it, then no.)
No
registration_3: If they do conduct an audit of compliance, do they share the summary results of this audit publicly?
No
registration_4: If they do conduct an audit of compliance, do they share the line by line individual trial data from this audit publicly? (That is: the names of trials, and then whether they were in compliance with the policy, or not.)
No
registration_5: Does the policy include phase 4 trials? If they say "all" then this is assumed to include phase 4.
Yes
registration_6: Does their current policy describe the registration policy covering past trials?
Yes
registration_7: From what date does this policy apply? (Give explanation of how year is used eg "trials initiated after 2001" or "trials used in regulatory approval since 2003" etc, or if not other details given then "200x NOS" [not otherwise specified]).This date is normalised after the second "/" to permit comparisons between companies. The average duration of a clinical trial is 2 years, as per Pregelj 2015. Therefore we normalise to NOS date. If a company commitment is "trials initiated after 2010" then this becomes "2011", if the commitment is "trials completing after 2012" then this becomes "2011", and so on. Whole years are used for simplicity.
No date given / note this was problematic to score for our audit: the company give no date, but they stated to us that this is because their policy covers all trials and there is no start date.

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Summary results

Why summary results are important

It is important that doctors, researchers, and patients have access to the summary results of every trial. These are the kinds of results you would typically find in an academic journal article: how the people in each arm of the trial did, over the course of the trial, measured by various criteria. This graph shows how LEO Pharma’s policy on sharing summary results compares to others’.

Measures

We assess every company’s policy by reading through their commitments, and checking off whether they meet a range of criteria. We send every company our assessment, then apply a scoring system to each element. You can read about the scoring system here. You can read our detailed assessment of whether LEO Pharma meets each of our criteria, below.

results_1: Do they have a policy to make all summary results available? (Excepting specific exclusions in later columns).
Yes
results_2: Do they commit to post summary results on pre-specified primary and secondary outcomes to clinicaltrials.gov within 12 months of completion? (Here, we are strict on 12 months, because without a time commitment there is effectively no commitment; where there is a longer time commitment, we give no and specify the delayed time period in a comment. If a company only says it commits to comply with legislation they get "no" here, as legislation does not cover all trials.)
Yes
results_3: Do they commit to post summary results to their own website within 12 months of completion? (Note same conditions on "within 12 months" apply as for posting results on clinicaltrials.gov).
Yes
results_4: Do they commit to submit all trial results to an academic journal within 12 months of completion. (This cannot be with caveats, eg "we submit all medically important results" scores "no").
No / no timeline given, not all trials
results_5: Does this commitment to post summary results include unlicensed treatments?
Yes
results_6: Does this commitment to post summary results include unlicensed uses of licensed treatments? (In the absence of a clear commitment either way: if the company does not post summary results on unlicensed treatments, the answer on unlicensed uses of licensed treatments is assumed to also be "no"; if the company has a clear theme of "all" trials throughout their policy, then the answer is assumed to be "yes").
Yes
results_7: Does this commitment to post summary results include phase 4 trials? (In the absence of a clear commitment either way, if there is a clear theme of "all" throughout the policy document, for example if they have made commitments to phase 2-4 trials for other aspects of their policy and there is no reason to believe that this issue would be an exception to that, then this is "yes").
Yes
results_8: Does their current policy cover results of past trials, committing to make all results available (excepting specific exclusions in later columns)? If this commitment is only for a poorly defined subset of trials, such as "medically important results", this is coded as "no".
Yes
results_9: Do they commit to post summary results of all past trials (excepting specific exclusions in later columns) on pre-specified primary and secondary outcomes to clinicaltrials.gov? (Note this does not require a 12 month criteria for posting results).
Unclear
results_10: Do they commit to post summary results of all past trials (excepting specific exclusions in later columns) to their own website? (Again, the retrospective commitment does not include a "within 12 months" requirement).
Yes
results_11: Do they commit to submit all trials to an academic journal. (Note this must be all trials, not "all interesting trials" etc).
No
results_12: Does this commitment to posting summary results of past trials include trials on unlicensed treatments?
No
results_13: Does this commitment to posting summary results of past trials results include unlicensed uses of licensed treatments? (In the absence of a clear commitment either way: if the company does not post summary results on unlicensed treatments, the answer on unlicensed uses of licensed treatments is assumed to also be "no"; if the company has a clear theme of "all" trials throughout their policy, then the answer is assumed to be "yes").
No
results_14: Does this commitment to post summary results of past trials include phase 4 trials? (In the absence of a clear commitment either way, if there is a clear theme of "all" throughout the policy document, for example if they have made commitments to phase 2-4 trials for other aspects of their policy and there is no reason to believe that this issue would be an exception to that, then this is "yes").
Yes
results_15: From what date does this policy on posting summary results for all trials apply? (Give explanation of how year is used eg "trials initiated after 2001" or "trials used in regulatory approval since 2003" etc, or if not other details given then "200x NOS" [not otherwise specified]).This date is normalised after the second "/" to permit comparisons between companies. The average duration of a clinical trial is 2 years, as per Pregelj 2015. Therefore we normalise to NOS date. If a company commitment is "trials initiated after 2010" then this becomes "2011", if the commitment is "trials completing after 2012" then this becomes "2011", and so on. Whole years are used for simplicity. For "drugs approved after year x" an additional year is added. So "approved after 2013" would normalise to "2011". There is no perfect method to make dates comparable between companies.
1990 nos / 1990

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Clinical study reports

Why Clinical Study Reports are important

Clinical Study Reports (CSR) are large detailed documents, sometimes thousands of pages long, which contain a wealth of detail on the methods and results of a trial. That information is often missing from other sources: one recent study estimates that CSRs contain twice as much information on benefits and harms as academic papers on trials. CSRs are routinely created for industry trials, but are less well known in the academic community. They follow a standard format set out under international guidance. This graph shows how LEO Pharma’s policy on sharing CSRs compares to others’.

Measures

We assess every company’s policy by reading through their commitments, and checking off whether they meet a range of criteria. We send every company our assessment, then apply a scoring system to each element. You can read about the scoring system here. You can read our detailed assessment of whether LEO Pharma meets each of our criteria, below.

csrs_1: Do they have a policy on sharing Clinical Study Reports (CSRs) at all?
Yes
csrs_2: Do they commit to share CSRs?
Yes
csrs_3: Is access to CSRs on request only, rather than prospectively posting CSRs online? (If only on request, summarise in comment how onerous the request process is, e.g. is it the same high level of workload as for a full IPD request, with extensive review of request and requesters; or is this just being used to prioritise which CSRs to share by the company?)
No
csrs_4: Spare coding space for CSR issues [not currently used].
csrs_5: Does this commitment to sharing CSRs include trials on unlicensed treatments?
No
csrs_6: Does this commitment to sharing CSRs include unlicensed uses of licensed treatments? (In the absence of a clear commitment either way: if the company does not share CSRs on unlicensed treatments, the answer on unlicensed uses of licensed treatments is assumed to also be "no"; if the company has a clear theme of "all" trials throughout their policy, then the answer is assumed to be "yes").
No
csrs_7: Does the policy commit to sharing synopses only? (This means: are synopses the only part of the CSR ever made available? If actual CSRs are available on request, and the synopses are routinely published, then this field is coded "no", and the CSR sharing policy is coded as for their policy on sharing CSRs proper).
No
csrs_8: Does their current policy cover CSRs of past trials?
Yes
csrs_9: Is access to CSRs on request only, rather than prospectively posting CSRs online? (If only on request, summarise in comment how onerous the request process is, e.g. is it the same high level of workload as for a full IPD request, with extensive review of request and requesters; or is this just being used to prioritise which CSRs to share by the company?)
No
csrs_10: Does this commitment to sharing past CSRs include trials on unlicensed treatments?
No
csrs_11: Does this commitment to sharing past CSRs include unlicensed uses of licensed treatments? (In the absence of a clear commitment either way: if the company does not share CSRs on unlicensed treatments, the answer on unlicensed uses of licensed treatments is assumed to also be "no"; if the company has a clear theme of "all" trials throughout their policy, then the answer is assumed to be "yes").
No
csrs_12: Does the policy commit to sharing synopses only? (This means: are synopses the only part of the CSR ever made available? If actual CSRs are available on request, and the synopses are routinely published, then this field is coded "no", and the CSR sharing policy is coded as for their policy on sharing CSRs proper).
No
csrs_13: From what date does this policy on sharing CSRs apply? (Give explanation of how year is used eg "trials initiated after 2001" or "trials used in regulatory approval since 2003" etc, or if not other details given then "200x NOS" [not otherwise specified]).Note after the second "/" this date is normalised, as per previous date column. "Filed with regulator" assumed to be same as "completed".
1990 nos / 1990
csrs_14: Details on additional exclusions and redactions regarding CSR sharing may be posted here, but the definitive source is the full text of the policy.
They share csrs publicly, it's only the appendices that are on request only. with the position on public access to clinical trials information, leo pharma commits to publishing clinical study reports for all leo pharma sponsored clinical studies on our corporate website, once the product has been approved or the project has been terminated and the results have been published in the scientific literature, regardless of whether the results reflect positively or negatively upon our products. if publication in scientific literature is not pursued, the clinical study report will be available within 12 months following the completion of the study.this commitment will be implemented from january 2014 for on-going and future clinical trials. clinical study reports and summaries for trials dating back to 1990 will be made available gradually from 2014 to 2017. publishing clinical study reports and summaries from older trials is resource-intensive, and it will therefore take some time for all clinical study reports dating back to 1990 to be made available. where necessary, data will be removed in order to be able to maintain patient confidentiality and commercially confidential information. appendices will only be available upon request. clinical study reports for abandoned projects will be posted on our corporate website from 2014 and moving forward.

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Individual patient data

Why Individual Patient Data is important

Individual Patient Data (IPD) is the raw data collected during a clinical trial, with detailed information on each individual participant. It presents significant opportunities for research. For example, access to IPD can allow third parties to verify that trialists analysed their data correctly and fairly. It helps researchers combine data from lots of trials for more accurate comparisons of treatments. It helps see if a treatment is particularly effective, or unhelpful, in a subset of patients. It also allows entirely new hypotheses to be explored in existing data, helping to devise or refine new treatments. However it also presents a risk: individual patients can often be re-identified, and their privacy compromised, even with partially anonymised data. Because of this, IPD is not generally posted in public, but shared through various controlled access mechanisms, as with other forms of electronic health record data already used by medical researchers. This graph shows how LEO Pharma’s policy on sharing IPD compares to others’.

Measures

We assess every company’s policy by reading through their commitments, and checking off whether they meet a range of criteria. We send every company our assessment, then apply a scoring system to each element. You can read about the scoring system here. You can read our detailed assessment of whether LEO Pharma meets each of our criteria, below.

ipd_1: Do they have a policy to make individual patient data (IPD) from clinical trials available on request?
Yes
ipd_2: From what date does this policy on sharing IPD apply? (Give explanation of how year is used eg "trials initiated after 2001" or "trials used in regulatory approval since 2003" etc, or if not other details given then "200x NOS" [not otherwise specified]). Note after the second "/" this date is normalised, as per previous date column. "Filed with regulator" assumed to be same as "completed".
2000 nos / 2000
ipd_3: Does this commitment to sharing IPD include trials on unlicensed treatments?
No
ipd_4: Does this commitment to sharing IPD include unlicensed uses of licensed treatments? (In the absence of a clear commitment either way: if the company does not share IPD on unlicensed treatments, the answer on unlicensed uses of licensed treatments is assumed to also be "no"; if the company has a clear theme of "all" trials throughout their policy, then the answer is assumed to be "yes").
No
ipd_5: Does the policy include phase 4 trials? If they say "all" then this is assumed to include phase 4.
Yes
ipd_6: Are there any additional exclusions? (For IPD sharing the answer is almost always "yes").
Yes
ipd_7: Do they say they consider requests for IPD on additional trials not explicitly covered by their policy?
No
ipd_8: Details on additional exclusions and redactions regarding IPD sharing may be posted here, but the definitive source is the full text of the policy, and a structured review of all restrictions in IPD sharing policies is beyond the scope of this audit.
After the leo pharma position on public access to clinical trials information has come into effect, itwill be possible for researchers to request access to anonymised patient level data from clinical trials sponsored by leo pharma for approved products dating back to 2000 when the clinical study report is listed on our website.starting in 2014, clinical study reports will be made available on the leo pharma website once the medicine studied has been approved or terminated from development, and when publication of the results has been pursued. in the case that publication of the results of studies and terminated projects is not to be pursued, the data from such studies will be available within 12 months of study completion. requests to access individual data from these trials will be evaluated by an independent patient and scientific review board. a review process is necessary to ensure that the request has a valid scientific rationale, is in the best interest of patients, and that granting access will not violate principles of informed consent or patient confidentiality.application forms and instructions for how to request access to data will be available on our corporate website, www.leo-pharma.com, from january 1, 2014.the patient and scientific review boardrequests for access to patient level data will be reviewed by a patient and scientific review board. the board will comprise three independent researchers, and two seats on the board are reserved for representatives from patient associations.the patient and scientific review board will accept or reject requests for data from clinical trials sponsored by leo pharma. data must only be used for addressing a scientific question or conducting analysis in the interest of public health. the request for access to data must explain the aim of using the data and a description of the proposed analytical practice. in order not to compromise patient confidentiality, clinical trials data may not be used for any purpose outside of the boundaries of patients’ informed consent. the results of the research must be made publicly available.the board will meet four times a year to review requests for access to data from clinical trials sponsored by leo pharma. detailed information on the composition and procedures of the board will be available in the patient and scientific review board charter, which will be available on the leo pharma website january 1, 2014.
ipd_9: Changes since 2015? Notes.