How transparent are Roche’s clinical trials?

Roche

Registration 0/500

(0%)

Summary results 180/500

(36%)

Clinical study reports 224/500

(45%)

Individual patient data 103/500

(21%)

Transparency rank

Est. sales (USD)

$50bn

Known for

Rituxan, Avastin, Herceptin

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

42 out of 46

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 Roche’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 Roche 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?: Unclear / this is hard to code. roche's policy pdf "roche global policy on sharing of clinical trials data" does not appear to make a clear statement about registration. it has a section header that mentions it, but the text only refers to "summary reports": "clinical trial registration and posting of results on public web sitesroche is committed to providing comprehensive information on clinical trials conducted by roche to healthcare professionals and to the public, regardless of the outcome of these trials. roche posts summary reports on clinicaltrials.gov (ct.gov) for all roche-sponsored phase i clinical trials in patients, all phase ii–iv interventional and observational clinical trials, and all roche-sponsored interventional trials that use diagnostic products." there is another mention related to registration in a second roche policy document titled "roche global policy on sharing of clinical study information" that reads: "we publish information from our protocols and clinical study results information on clinical trial registries. clinical trial registries are an important source of information for physicians and patients because they help them to know if a study is recruiting, ongoing or is completed. clinical trial registries also help physicians and patients access results once available." again we do not view that as a clear commitment to register all trials. in addition, on the webpage "our commitment to data sharing", a third policy document containing information about roche's commitments, (http://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm ) they say: "roche's clinical trials registry was launched in 2004 with the aim of ensuring researchers and other interested parties could access protocols and also the results of our phase i to iv clinical studies" and "roche is committed to sharing data from clinical trials and has registered and posted summary reports for trials involving patients on appropriate clinical registries since 2005." collectively this may mean that roche register all trials, since 2005, but this is not made clear. this lack of clarity is made more problematic by the apparent conflict with the 2013 start date (see relevant field) for sharing all summary results: i.e., one could accept this vaguely worded commitment for 2005 as covering registration of all trials from 2005, but that would then naturally imply accepting that all summary results are shared from 2005 as well; however the parts of the roche policy document (or rather, documents) that discuss results policy appear to suggest 2013 as the start date for all trials to share summary results. therefore, although it is an edge case, this can only be realistically coded as unclear on registration, because it lacks a clear commitment to "all", and the most permissive/generous reading of the text produces a result that is inconsistent with other aspect of roche's policies.
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?: Unclear / this is hard to code. roche's policy pdf "roche global policy on sharing of clinical trials data" does not appear to make a clear statement about registration. it has a section header that mentions it, but the text only refers to "summary reports": "clinical trial registration and posting of results on public web sitesroche is committed to providing comprehensive information on clinical trials conducted by roche to healthcare professionals and to the public, regardless of the outcome of these trials. roche posts summary reports on clinicaltrials.gov (ct.gov) for all roche-sponsored phase i clinical trials in patients, all phase ii–iv interventional and observational clinical trials, and all roche-sponsored interventional trials that use diagnostic products.". in addition, on the webpage "our commitment to data sharing" (http://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm ) they say: "roche's clinical trials registry was launched in 2004 with the aim of ensuring researchers and other interested parties could access protocols and also the results of our phase i to iv clinical studies" and "roche is committed to sharing data from clinical trials and has registered and posted summary reports for trials involving patients on appropriate clinical registries since 2005." collectively this may mean that roche register all trials, since 2005, but this is not made clear.
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.: 2005 nos this is hard to code. roche's policy pdf "roche global policy on sharing of clinical trials data" does not appear to make a clear statement about registration. it has a section header that mentions it, but the text only refers to "summary reports": "clinical trial registration and posting of results on public web sitesroche is committed to providing comprehensive information on clinical trials conducted by roche to healthcare professionals and to the public, regardless of the outcome of these trials. roche posts summary reports on clinicaltrials.gov (ct.gov) for all roche-sponsored phase i clinical trials in patients, all phase ii–iv interventional and observational clinical trials, and all roche-sponsored interventional trials that use diagnostic products.". in addition, on the webpage "our commitment to data sharing" (http://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm ) they say: "roche's clinical trials registry was launched in 2004 with the aim of ensuring researchers and other interested parties could access protocols and also the results of our phase i to iv clinical studies" and "roche is committed to sharing data from clinical trials and has registered and posted summary reports for trials involving patients on appropriate clinical registries since 2005." collectively this may mean that roche register all trials, since 2005, but this is not made clear. / 2005

10 out of 46

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 Roche’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 / "roche is committed to providing comprehensive information on clinical trials conducted by roche to healthcare professionals and to the public, regardless of the outcome of these trials. roche posts summary reports on clinicaltrials.gov (ct.gov) for all roche-sponsored phase i clinical trials in patients, all phase ii–iv interventional and observational clinical trials, and all roche-sponsored interventional trials that use diagnostic products."
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.): No / no timelines "roche posts summary reports on clinicaltrials.gov (ct.gov) for all roche-sponsored phase i clinical trials in patients, all phase ii–iv interventional and observational clinical trials, and all roche-sponsored interventional trials that use diagnostic products."
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).: No
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
results_5: Does this commitment to post summary results include unlicensed treatments?: Yes / "roche posts summary reports on clinicaltrials.gov (ct.gov) for all roche-sponsored phase i clinical trials in patients, all phase ii–iv interventional and observational clinical trials, and all roche-sponsored interventional trials that use diagnostic products."
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).: Yes / "roche's clinical trials registry was launched in 2004 with the aim of ensuring researchers and other interested parties could access protocols and also the results of our phase i to iv clinical studies. we established this site because the independent platforms available at the time did not enable us to publish all of the details we wished to share. since this time the regulations governing existing independent registries have changed and we are now able to share all relevant protocols and information on these platforms. as such, we are working to transition the information contained on the roche clinical trials registry to the nih clinicaltrials.gov and the ema eudract platforms."
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).: No
results_11: Do they commit to submit all trials to an academic journal. (Note this must be all trials, not "all interesting trials" etc).: Yes / "regardless of outcome, roche commits to submit the primary clinical study results for publication in a peer- reviewed journal in a timely, objective and clinically meaningful manner."
results_12: Does this commitment to posting summary results of past trials include trials on unlicensed treatments?: Yes / "roche posts summary reports on clinicaltrials.gov (ct.gov) for all roche-sponsored phase i clinical trials in patients, all phase ii–iv interventional and observational clinical trials, and all roche-sponsored interventional trials that use diagnostic products."
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").: Yes / "roche posts summary reports on clinicaltrials.gov (ct.gov) for all roche-sponsored phase i clinical trials in patients, all phase ii–iv interventional and observational clinical trials, and all roche-sponsored interventional trials that use diagnostic products."
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.: 2013 nos "the policy set forth in this document was adopted on 17 april 2013 and entered into force on 1 june 2013." note previous years' policies had other dates (e.g. 2002) but the current document gives no insight on dates beyond 2013. in addition: "this policy applies to clinical study reports and summary reports that have been used for regulatory purposes since 1 january 1999. it will also apply to reports that have not been used for regulatory purposes and are finalized on or after 1 january 2013." 1999 commitment covers limited set / 2013

3 out of 46

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 Roche’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 / simple request process and share with the public, i.e. no cvs or project description. "firstly, we will make the reports that we write on the clinical trial (called clinical study reports or csrs, periodic safety reports, and clinical trial summary reports) available to members of the public on request."
csrs_4: Spare coding space for CSR issues [not currently used].
csrs_5: Does this commitment to sharing CSRs include trials on unlicensed treatments?: Yes / depends on date but scoring most complete commitment 2013 "roche established the processes we use today for managing clinical study reports and the data from clinical trials in 1999. we will provide data from trials and clinical study reports from studies conducted as far back as 1999 if those studies have been used for regulatory purposes. in certain circumstances we may be able to provide csrs or other reports from trials conducted earlier. for trials which were not used for regulatory purposes, we will provide csrs from 1st january 2013." however note this is discrepant with their clinical study data request page which reads: "all phase 2 and 3 clinical studies or phase 4 studies that were used as part of a regulatory approval or where the product was terminated from development (all indications) with a first patient enrolled as of 1 january 1999 onwards. roche is in the process of compiling a list of studies in scope. roche will regularly update this list to add studies going back to january 1999. in the event that you cannot see a specific study in the roche list, an enquiry form can be submitted to confirm the availability of the specific study" and includes a commitment to share csrs. however since csr applications are open to all, including the public, not just academics requesting through csdr, then for csrs we have coded the commitment in their standalone policy document.
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").: Yes / depends on date but scoring most complete commitment 2013 "roche established the processes we use today for managing clinical study reports and the data from clinical trials in 1999. we will provide data from trials and clinical study reports from studies conducted as far back as 1999 if those studies have been used for regulatory purposes. in certain circumstances we may be able to provide csrs or other reports from trials conducted earlier. for trials which were not used for regulatory purposes, we will provide csrs from 1st january 2013."
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?: Yes / depends on date but scoring most complete commitment 2013 "roche established the processes we use today for managing clinical study reports and the data from clinical trials in 1999. we will provide data from trials and clinical study reports from studies conducted as far back as 1999 if those studies have been used for regulatory purposes. in certain circumstances we may be able to provide csrs or other reports from trials conducted earlier. for trials which were not used for regulatory purposes, we will provide csrs from 1st january 2013."
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").: Yes / depends on date but scoring most complete commitment 2013 "roche established the processes we use today for managing clinical study reports and the data from clinical trials in 1999. we will provide data from trials and clinical study reports from studies conducted as far back as 1999 if those studies have been used for regulatory purposes. in certain circumstances we may be able to provide csrs or other reports from trials conducted earlier. for trials which were not used for regulatory purposes, we will provide csrs from 1st january 2013."
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".: Depends on date but scoring most complete commitment 2013 "roche established the processes we use today for managing clinical study reports and the data from clinical trials in 1999. we will provide data from trials and clinical study reports from studies conducted as far back as 1999 if those studies have been used for regulatory purposes. in certain circumstances we may be able to provide csrs or other reports from trials conducted earlier. for trials which were not used for regulatory purposes, we will provide csrs from 1st january 2013." / 2013
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.

19 out of 46

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 Roche’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".: Initiated since 1999 / 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.: No / "exceptions... phase 4 clinical studies conducted for non-registrational purposes or local affiliate studies."
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?: Yes
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.: All phase 2 and 3 clinical studies or phase 4 studies that were used as part of a regulatory approval or where the product was terminated from development (all indications) with a first patient enrolled as of 1 january 1999 onwards. roche is in the process of compiling a list of studies in scope. roche will regularly update this list to add studies going back to january 1999.clinical studies with a sample size of less than 50 patients or in rare diseases. this is because anonymisation of these data is more difficult to achieve. for these studies roche will assess the feasibility of anonymisation as part of the review of enquiries. phase 4 clinical studies conducted for non-registrational purposes or local affiliate studies.after the medicine studied has been approved by regulators for the indication in both the us and eu or terminated from development (all indications). 18 months after completion of the study report (to enable a publication to be submitted).when patients agreed to take part in roche clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease roche were researching. further research must therefore study the medicine or disease that was researched in the original studies. for future studies (2014 onwards) patients will be asked to give permission for broader research so other research may be possible with data from these studies. a condition of providing the data is that the external requester seeks publication of their research results. roche are to be provided with a copy of the manuscript after journal submission for information. roche may chose to provide the requester with comments on the document as a courtesy, but the external requester is not obliged to incorporate any feedback resulting from this review.
ipd_9: Changes since 2015? Notes.