How transparent are Takeda Pharmaceuticals, Inc.’s clinical trials?

Takeda Pharmaceuticals, Inc.

Registration 312/500

(62%)

Summary results 315/500

(63%)

Clinical study reports 152/500

(30%)

Individual patient data 190/500

(38%)

Transparency rank

Est. sales (USD)

$16bn

Known for

Velcade, Protonix, Entyvio

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.

Registration
Summary results
Clinical study reports
Individual patient data

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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 Takeda Pharmaceuticals, Inc.’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 Takeda Pharmaceuticals, Inc. 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.: 2002 nos / 2002

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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 Takeda Pharmaceuticals, Inc.’s policy on sharing summary results compares to others’.

Measures

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
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).: No
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.: Medicines approved since 2005 / 2003

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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 Takeda Pharmaceuticals, Inc.’s policy on sharing CSRs compares to others’.

Measures

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?): Yes / laborious process like ipd
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?): Yes
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".: Medicines approved since 2005 / 2003
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.: "clinical trials will be listed for takeda-sponsored phase 1-4 interventional trials supporting approved products as described below. commercially available new medicines or vaccine products that have received marketing approval for a given indication or formulation since 01 january 2005 as follows: • us and eu approval.• us or eu approval (when regulatory submissions in both regions are not planned).• japan approval (when us or eu regulatory submissions are not planned).clinical trials will also be listed for takeda-sponsored phase 1-4 interventional trials relating to terminated compounds. terminated compounds are unapproved medicines or vaccines for which clinical development is completely terminated on or after 01 january 2014.takeda will only share clinical data when it is feasible to anonymize the data without compromising the privacy of trial participants. this may affect small clinical trials of rare diseases or trials with a very small number of patients, which will be reviewed on a case-by-case basis. prematurely discontinued trials that have insufficient enrollment/exposure to warrant analysis may not be listed. interim data from completed or ongoing clinical trials will generally not be shared. in rare cases, information may be restricted by takeda in order to protect commercially confidential information (cci) and intellectual property (ip) rights. takeda consumer healthcare products will not be subject to data sharing.clinical trials will be eligible for listing once the above criteria are met and the primary manuscript has been accepted for publication. for approved products, clinical trials supporting subsequent local approvals (including registration trials that specifically support approval in japan), new indications, combination products, or major formulation changes will be eligible for listing after the corresponding regulatory approvals have been achieved. takeda is in the process of listing trials in scope. takeda will regularly update this list to add trials meeting the criteria. for in-scope trials that are not yet listed, takeda will assess the feasibility of data provision as part of the review of enquiries...... documents will be redacted to protect personal data of trial participants, trial personnel, and takeda employees (consistent with applicable privacy laws/regulations), and to protect takeda’s cci and ip rights when required. takeda will not share case narratives, documentation for event adjudication, imaging data (e.g., x-rays, mri scans, etc.), genetic data, or other information that takeda considers may compromise trial participant privacy."

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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 Takeda Pharmaceuticals, Inc.’s policy on sharing IPD compares to others’.

Measures

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".: Medicines approved since 2005 / 2003
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.: Clinical trials will be listed for takeda-sponsored phase 1-4 interventional trials supporting approved products as described below. commercially available new medicines or vaccine products that have received marketing approval for a given indication or formulation since 01 january 2005 as follows: • us and eu approval.• us or eu approval (when regulatory submissions in both regions are not planned).• japan approval (when us or eu regulatory submissions are not planned).clinical trials will also be listed for takeda-sponsored phase 1-4 interventional trials relating to terminated compounds. terminated compounds are unapproved medicines or vaccines for which clinical development is completely terminated on or after 01 january 2014.takeda will only share clinical data when it is feasible to anonymize the data without compromising the privacy of trial participants. this may affect small clinical trials of rare diseases or trials with a very small number of patients, which will be reviewed on a case-by-case basis. prematurely discontinued trials that have insufficient enrollment/exposure to warrant analysis may not be listed. interim data from completed or ongoing clinical trials will generally not be shared. in rare cases, information may be restricted by takeda in order to protect commercially confidential information (cci) and intellectual property (ip) rights. takeda consumer healthcare products will not be subject to data sharing.clinical trials will be eligible for listing once the above criteria are met and the primary manuscript has been accepted for publication. for approved products, clinical trials supporting subsequent local approvals (including registration trials that specifically support approval in japan), new indications, combination products, or major formulation changes will be eligible for listing after the corresponding regulatory approvals have been achieved. takeda is in the process of listing trials in scope. takeda will regularly update this list to add trials meeting the criteria. for in-scope trials that are not yet listed, takeda will assess the feasibility of data provision as part of the review of enquiries.data sharing is constrained by the requirements of the informed consent obtained at the time each clinical trial was conducted. in general, new research conducted on shared data must assess the specific medicine, disease or objective that was assessed in the original trial. for takeda clinical trials initiated after this policy is enacted, patients will be asked to give permission for broader research beyond the original trial, so that other research may be possible with these data. where data is subject to legal, contractual, or consent provisions that restrict transfer to third parties, data access may be precluded. other practical constraints to providing access to the data may also preclude sharing.where available, the following anonymized patient level data and/or supporting documents are provided for each clinical trial. information/documents will not be translated and in rare instances practical issues relating to redaction and availability of non-english documents may limit sharing. raw dataset. this is the data collected for each patient in the clinical trial.analysis-ready dataset. this is the dataset used for takeda’s analysis.protocols with any amendments. this describes the objectives, design, methodology, statistical considerations, and organisation of a clinical trial.annotated case report form. this is a blank case report form with descriptions of the data collected and how they are described in the dataset.reporting and analysis plan. this describes methods of analysis, procedures for data handling and data displays (figures and tables) takeda used for the trial.dataset specifications. this is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.clinical study report. this is the report of efficacy and safety data from the trial. it forms the basis of submissions to regulatory authorities such as the food and drug administration (fda) and the european medicines agency (ema). appendices which include patient level data are generally not included as these data are provided in the datasets takeda provides. documents will be redacted to protect personal data of trial participants, trial personnel, and takeda employees (consistent with applicable privacy laws/regulations), and to protect takeda’s cci and ip rights when required. takeda will not share case narratives, documentation for event adjudication, imaging data (e.g., x-rays, mri scans, etc.), genetic data, or other information that takeda considers may compromise trial participant privacy.
ipd_9: Changes since 2015? Notes.