The Ethics of Reporting all the Results of Clinical Trials

Iain Brassington

CSEP/ School of Law, University of Manchester

Correspondence to

Iain Brassington

CSEP/ School of Law, University of Manchester, Oxford Road, Manchester M13 9PL

Tel (0161) 275 35 63

iain.brassington@manchester.ac.uk

Short Title: The Ethics of Reporting all the Results

ABSTRACT

Introduction or background

The terms “publication bias” and “reporting bias” describe aspects of a phenomenon by

which data from trials are not publicised, and so remain inaccessible. This may generate a

false impression about the world; but those facts may have important implications for clinical

decisions. Thus the bias may leave patients worse off than they might be.

Sources of data

Published journal articles

Areas of agreement

There is general agreement that the phenomenon happens, and that to the extent that it

happens, it is undesirable for moral rather than simply epistemic reasons

Growing points

There is a growing demand across the board for data to be better publicised

Areas timely for developing research

There is room for further work on how protocols requiring that data be publicised might be

enforced; should it be statutory, or non-statutory? Who should decide what should be made

public? There is also room for work on what it is necessary to share, and on whether and

how IP law should be reformed.

KEYWORDS

Clinical trials; publication bias; reporting bias; AllTrials; research ethics; data-sharing

THE ETHICS OF REPORTING ALL THE RESULTS OF CLINICAL TRIALS

Here is a letter published by the Journal of the American Medical Association in 1927:

One of the things we practitioners sometimes neglect is the reporting of failures. In THE JOURNAL, Oct.

2, 1926, Dr. Richard L. Sutton, with proper scientific reserve, reported the treatment of six consecutive

cases of warts with intramuscular injections of sulpharsphenamine. As a result of this communication,

I venture to guess that not less than a hundred physicians, perhaps several hundred, injected

sulpharsphenamine into patients with warts. Supposing that 99 per cent get negative results, what

happens? Each of them gives up the method as a failure and does not say anything more about it, and

the treatment remains on record as an undisputed success. Possibly 1 per cent who meet with success

will communicate with Dr. Sutton, so that by and by he will have quite an impressive series of cases,

comparable with the mercurochrome successes published in a recent number of THE JOURNAL.

To practice what I am preaching, let me now report that on November 30, I injected 0.4 Gm. of

sulpharsphenamine (Squibb) into the left buttock of E.M.B., a girl, aged 18, who was at that date

complaining of the presence of twenty-four warts distributed mostly over the hands and arms. At the

present date, there are twenty-eight warts, and evidence of regressive changes in the original twenty-

four has not been seen.1

The phenomenon that the letter discusses calls attention to an instance of what we would

today call reporting bias or publication bias: a phenomenon whereby the results from some

trials never make it into the public domain, and a false impression of a treatment’s

effectiveness is thereby given. Though some have claimed to be unable to find compelling

evidence of this phenomenon2, others have found that it is real3,4. To whatever extent that it

does occur, several sources insist that the non-publication of data is in some sense

“unethical”5-9, or that publication of all results is an ethical imperative10. What is not so clear

is whether and why that would be true. More importantly, if not reporting all the results is so

obviously unethical, we might wonder why people don’t. What, then, is the moral status of

publishing all the results of clinical trials?

To answer that question, I shall spend a little time looking at the nature of the phenomenon,

and consider a selection of responses. I hope to be able to show is that there is a genuine

problem here, at least formally: that there are reasons both to publish and not to publish all

trial results; but that (at least when considered from an ethicist’s perspective), it is a problem

that to which the desirable response is fairly straightforward.

Why does Non-Publication Matter?

It is not difficult to ascertain why the phenomenon might is important. It is surely desirable

to have as good an idea as possible about the effectiveness and safety of drugs and treatments

before they are used in the clinic. Presumably, we would want information on promising

treatment modalities to be publicised; but there same would apply to information on

unpromising ones. By “information”, we may mean the raw data from a trial, or the results

that are yielded by the analysis of those data. The moral arguments may alter slightly

depending on which we mean when talking about publication, but their general thrust is

likely to be similar; I shall pare them as necessary as the paper progresses, but many of the

arguments apply to at least some extent to both.

There are four lines of argument at play. The first is perhaps the least obviously an ethical

concern in the everyday sense of the word; it relates to the character – the ethos – of scientific

research. Ferguson and Heene note that the integrity of science draws on replication and

falsifiability;11 this sentiment is echoed in a letter to The Lancet from Francoise Baylis and

Matthew Herder from 201512. This suggests that we might be able to insist that science that

does not accommodate replication and falsification is imperfect science. We might even be

able to push things further, making a recognisably Popperian claim that falsifiability is crucial

to distinguishing science from non-science, and that therefore an experiment that is not

replicable or falsifiable may not count as scientific at all, let alone as imperfectly scientific.

This would matter for the problem under consideration here, because both replication and

falsifiability are undermined when some outcomes remain unpublished.11 Not publishing

data (or, at least, not aspiring to publish them), the argument goes, therefore corrodes the

nature of the scientific endeavour, and so violates its “internal morality” – the set of standards

that make an endeavour the endeavour it claims to be. But is not only the ethos of research

that suffers; clinical research is supposed to generate further goods, and replication and

falsification processes are crucial to that. It seems to follow that anything that undermines

this process will be morally problematic on that account as well. This brings us neatly to the

second line of argument, which has to do with patient welfare.

Non-publication may lead to clinicians making decisions based on skewed information (p.

911)13, 14. Suppose a medic is persuaded by promising trial reports to opt for new a drug, ,

in favour of the more established to treat a condition; but suppose also that some

significant portion of the trials into ’s effectiveness had shown it to be less effective than ,

and that these “null” outcomes never reached the journals. In that case, our medic will be

choosing a suboptimal treatment.15 Since using often means not using , the patient will

therefore be worse off than she otherwise might have been, and might also be worse off in

absolute terms if her condition gets worse in the meatime.16 This suggests that there is a

beneficence-based reason to think that researchers should publish whatever clinical trial

results they can. After all, if they are doing that research for the sake of patients (which is at

worst the noble lie of commercial pharmaceutical companies, and may very well be true of

individual researchers), it seems bizarre not to endorse measures that would prevent the

administration of useless treatments. A number of commentators claims that research must

be socially valuable to be morally permissible at all (p. 2703)17, (p. 4)18, (p. 21)4. If that’s

true, then research the outcome of which is not published is prima facie impermissible. More

seriously, there might be cases in which a theoretically promising drug is found to have

undesirable side-effects. If studies reporting this are not published, other researchers may

repeat trials on it, thereby putting more trial participants and, potentially, patients at risk (p.

1577)19,20. (Ben Goldacre provides a particular example of this in respect of VIOXX (p.

95f)21.)

This consideration also raises a concern about justice, an appeal to which provides the third

reason why non-publication matters. If unpublished research was looking at a plausible

hypothesis, it would not be unreasonable to expect that more than one group would be

investigating it; non-publication increases the chance of time and treasure being wasted

chasing the same wild goose repeatedly. Thus the desirability of replication as part of the

ethos of science has a mirror image in the desirability of avoiding unnecessary duplication (p.

2)16.

There is another element to the justice argument. Drugs have to be paid for, whether by the

taxpayer or the patient. It is straightforwardly unjust to be expected to contribute to the cost

of drugs that are known by some to be ineffective, or the ineffectiveness of which is obscured

by means of an incomplete publication record (p. 21)4. An example of this comes from the

UK government having paid £424m stockpiling Tamiflu despite the absence of any

consensus about its effectiveness;22 this is presumably public money that need not have been

spent, or that could have been better spent. Furthermore, resources spent on work that

languishes in researchers’ bottom drawers are resources wasted;23,6 and since medical

research is often partially funded by charities, this seems to be particularly worrisome.

(There is an important aside to be made here. In all these cases, users and funders may have

been deceived into prescribing or paying for things that cannot provide what they appear to

promise. Still, this does not imply that there must be deliberate deceit for any of these

arguments to bite. It might be that results are withheld in bad faith; but there are good faith

reasons to withhold them, too, and I shall consider them in a moment. That deception occurs

does not mean that anyone intends it.)

Finally, Dickersin and Chalmers make an argument for publication of data that appeals to the

motivations of trial participants: “[p]articipants in clinical research are usually assured that

their involvement will contribute to knowledge; but this does not happen if the research is not

reported publicly and accessibly” (p. 532)6. This concern has been echoed in a recent

statement by the ICJME:

The International Committee of Medical Journal Editors (ICJME) believes that there is an ethical

obligation to responsibly share data generated by interventional clinical trials because participants have

put themselves at risk.24

Tacit in these statements is an appeal to a social contract: participants make sacrifices, and it

is owed to them that this sacrifice should be given the greatest possible chance of having an

impact.25 Whether this argument generates anything like an obligation to publish data is

uncertain; but there would seem all the same to be at least a reason to consider publication

based on respect for patients’ motivations.

However we approach it, there would seem to be plenty of reasons to think that morality

requires that the outcomes of clinical trials be published in some form.

Why Aren’t Results Published?

If the moral arguments against non-publication of trial data are so straightforward, why aren’t

all trial outcomes published? Two kinds of answer to that are possible, one framed as

explanation, and the other framed as justification.

One of the most mundane explanations for non-publication of clinical trial data and results is

that experiments that yield apparently uninteresting results – results that are not (or are not

held to be) statistically significant – may not even be submitted for publication, on the basis

that there is simply nothing to report, or that a null finding does not merit the effort of

reporting it.21, 26 Thus some reporting bias may creep in before papers’ (non-)submission to

journals.27 Importantly, Chan et al report having found no evidence that non-positive results

are less likely to be published once submitted, “indicating that investigators do not submit

reports of studies with negative results” (p. 259)26 – although, of course, we may never know

whether non-positive results would have been published if they had been submitted for

publication. They may not have been: peer-reviewers are often directed to evaluate the

novelty of research28. Thus research may vanish on the fallacious assumption that null results

make no scientific contribution. This fallacy may explain non-publication, but if there is an

all-else-being-equal moral reason to publish, it will not excuse it.

A related reason for results having gone missing is the importance of impact metrics from

published papers. In an academic culture in which success is measured by citation rates,

there is less incentive to put the work into a paper that is not expected to attract citations (p.

30)21 – and there is evidence that non-statistically significant results are cited less often (p.

272)29. At the same time, journals can afford to be selective about which papers they accept,

and will themselves have a bias towards eye-catching claims: after all, “journals… compete

for readers” (p. 33)21. In passing, this would militate against publishing the replication

studies that lend credibility to a claim but are obviously secondary to it; and since researchers

know this, they would be less likely to carry them out, thereby increasing the chance of a

fluke result having a greater importance than it merits. Yet, again, explaining behaviour

won’t necessarily justify it; and so reviewers and editors may come in for criticism for

fostering the kinds of fallacy that inhibit researchers.

Why Shouldn’t Results be Published?

If non-publication may sometimes be explicable by a kind of reticence from researchers, the

outcome may still be that it leads to clinically sub-optimal outcomes. What it does not imply

is bad faith. Potentially more worrisome is the possibility that the (commercial) funders of

trials deliberately choose to withhold data that are not supportive of a particular product.

There is a business reason to do this, and no shortage of examples: Ben Goldacre provides

handy lists of instances (passim, but esp. p. 59)21,30. Such practices look like actions that can

only be performed in bad faith; as we shall see, they need not always be.

There are several available lines of positive argument against publishing everything. One

concern is that there can be too much information. Castellani worries explicitly that

“dumping millions of pages of clinical trial information into the public domain” would

ultimately undermine public trust in medical research by making it easier for the public to

second-guess expert decisions.31 At the very least, having millions of pages of documentation

visible may make no positive difference to the good.

A second reason not to publish all results has to do with protecting the rights of the research

subjects. It is more or less a given that pains should be taken to protect the identities of

people who participate in trials; but the more information about trials is published, the greater

the risk that participants will be identified.31 Indeed, some have suggested that the greater the

steps to maintain anonymity, the harder to interpret the data might be32; this generates a

problem because there’s less justification for sharing data that are less likely to be useful. If

we think that participant privacy is a primary concern, it would therefore seem permissible or

obligatory to withhold certain trial results from publication, especially if they appear not to

make a positive contribution to knowledge that might offset the risk of identification.

A third objection to publishing everything rests on an appeal to intellectual property rights

and commercial sensitivity. Broadly, the argument is that information from trials is the

intellectual property of the researcher or sponsor, and is commercially valuable. This gives

researchers a reason to be careful about publication that can be framed in terms of data being

legally-protected trade secrets (p. 484)33. One only needs to add a (fairly unremarkable)

claim that companies have a moral obligation to do the best by their shareholders to see how

a moral argument for not publishing might be generated.32 On this, Hopkins et al have noted

that data generated in the course of a trial have a history of having been considered the

private property of the researcher (p. 17)34. Though they are considering data sharing by

means other than publication of results, the principle would stand that, if the sponsor of a trial

preferred not to publish data that counts as a trade secret, there would be at least a prima facie

reason to think that that was their prerogative. (Kesselheim and Mello seem at least vaguely

sympathetic to this argument (p. 489)33.) And though an appeal to law is unlikely to settle

moral disputes, it does seem reasonable to assume that the legal protections offered to

intellectual property offer a possible moral defence of non-publication, since preferring not to

break a law that is not gratuitously unjust is generally morally permissible.

It is the fact that there are reasons not to publish all results in principle that turns a

phenomenon about publishing – presumably undesirable, but something that can be fixed –

into a moral problem: there obtain moral reasons to publish, and competing moral reasons not

to. There are legitimate concerns that should be addressed,24 even if they are in the end

overcome. So how compelling are the reasons not to publish? Probably not very.

In Defence of Publication

Castellani’s worry about wide dissemination of information being counterproductive is easily

dismissed. People are wont to second-guess expert decisions anyway, drawing on all kinds of

sources; having trial data available cannot make the situation any worse, and it may improve

matters. Indeed, having data available to be analysed by outsiders may be desirable,

precisely because they may find things that would otherwise be missed. Neither does

dissemination create worrying levels of confusion: as Goldacre writes,

disputed interpretations are widespread throughout science and medicine, they are normal, and this

open debate is how we get closer to the truth. [… W]e do not silence medical scaremongers in the

media by hiding information about trials; if anything, routinely withholding trial results is more likely

to undermine public trust.30

Even fairly minimal data sharing will bring benefits. Therefore even if we allow that

publishing all results is undesirable, that does not preclude limited publication, or at least a

public register of trials. Clinicians and researchers could then perform fairly straightforward

searches to see how the trials supporting ’s success stand in relation to the total number of

trials. This would make for easier treatment decisions, and help to direct future research;

after all, if 20 trials on have been registered over a given period but only 3 published, that

tells us something about the justification for using . (In an interesting sense, whether

actually does work is neither here nor there; what matters for treatment decisions is whether

the evidence supports it.)

Neither should concerns about privacy and confidentiality be insurmountable. Consent for

data-sharing can be made explicit; and (as Hopkins et al note) “even if explicit consent to

share anonymized data has not been requested from patients in ongoing or completed trials,

this does not preclude the sharing of anonymized data” (p. 23)34. While the risk of

identification does grow each time trial outcomes are shared, it would not take much to keep

it small all the same. Correspondingly, Ben Goldacre states explicitly that the AllTrials

campaign is not calling for routine publication of individuals’ data anyway.30 It ought to be

possible to give “broad” results a public airing as a matter of course; granted that some

researchers may have a legitimate cause to see detailed results, possibly including subjects’

medical histories, a mechanism to allow that could be devised. I shall return to this in a

moment.

The idea that laws designed to protect intellectual property might militate against data-

sharing in some form is also not obviously correct, though there is more of a debate to be had

here. Admittedly, we should admit that there are commercial interests that merit

acknowledgement: it is not unreasonable to think that there ought to be some non-zero level

of protection for clinical trial results. Moreover, even if one thinks that the IP regime ought

to be much more liberal, the fact remains that there is such protection as a matter of fact;

while breaking unjust laws may be permissible in some cases, whether the current legal

situation is sufficiently unjust to warrant that kind of action, and who should carry the burden

of performing it, are further questions. We might admire someone who leaks information,

and think that it should have been leaked, but still predict that he would and think that he

should face legal sanction on the basis that the law is what it is, that the rule of law is a good

thing, and that long as the law is valid it ought to be enforced, even if it ought to be changed.

In other words, researchers might well be able to say, with some hope of success, that

publishing results is desirable all else being equal, but that morally legitimate responsibilities

to partners give a reason not to.

Yet the law protecting IP is at root a set of conventions that can, and sometimes should, be

changed; the arguments outlined above provide us with good reasons to think that publication

is morally desirable, and therefore with a reason to think that the law should accommodate it.

Mathias Risse has begun to chip away at the intellectual foundation of the IP argument by

raising questions about the very ownability of the products of scientific endeavour (passim

but esp. p. 30)35. If there is anything to his argument, we could use it to discount the worries

about commercial sensitivity. Even if Risse’s claims are unconvincing, we might still note

the difference between data and results. Results might be enforcably ownable insofar as that

they are data with which an agent has “mixed his labour”; but it does not follow from that

that intellectual property claims over the raw data would be as strong. And, of course, in both

cases, we might be inclined to think that the only reason not to publish negative data and

results is based in commercial concerns that are easily trumped by the public interest in their

dissemination. After all: it is not as though a firm would want to make a public case for the

importance of securing the market in a drug that it knows to be ineffective.

Indeed, there is a perceptible movement in the law towards favouring publication. Section

801 of the American Food and Drug Administration Amendments Act 2007 requires that trial

data be published online.36 At the very least, it creates a database that makes it possible to see

what research has been undertaken, even if full results are not published.37 The EU has its

own regulations about publicising research data,38 and the case law is not unsympathetic to

publication – see, for example, the eventual outcome of EMA v AbbVie.39 In fine, the IP-

based arguments against publication are not conclusive, and do not rebut the moral arguments

for publication.

What Should be Done?

American law has required the registration of all trials and results for almost a decade, via

clinicaltrials.gov;40 the AllTrials campaign has been making the case for a comprehensive

register in the UK since 2013.41 In 2015, the World Health Organisation formally called for

“key outcomes” from all trials to be made public – “key outcomes” here meaning, at

minimum, “participant flow, baseline characteristics, primary and secondary outcome

measures, and adverse events including all serious adverse events and important anticipated

or unanticipated adverse events” – with the results submitted for publication in a peer-

reviewed journal.10 The potential problem that researchers’ good faith may be held hostage

by peer-reviewers is answered by the requirement that research only needs to have been

submitted, and that the outcomes should be publicly visible even without formal publication.

Even so, we might still want to know more about where those results should be publicised,

what kind of embargo there might be, what counts as “serious” and “important”, and how all

these considerations should be weighed against legally-protected commercial interests.

A big set of questions concerns enforceability. Should the moral ideal of publication be

handled by law – and if so, how? – or simply by public pressure? It is tempting to say that

statutory or quasi-statutory means are the only options. However, they may not be all that

reliable: a 2011 study found that only 22% of the trials that ought to have been registered

under the terms of the American law had been;42 later studies indicate that improvement is

slow,43 and that registration rates do not correlate with publication rates, which may be

lower4, (p. 257-8)26 (though van Lent et al are more upbeat43). One possible explanation for

this is that large pharmaceutical companies may expect to make so much profit from

blockbuster drugs that any legal liabilities incurred from not publicising all trials can be

written off quite straightforwardly32 – if a penalty is ever applied in the first place.43

There are options to encourage publication of data that stop short of law. The UK’s Health

Research Authority sets non-statutory standards for transparency (in the form of trial

registration) that go beyond what would be required by the European directive.44 Since the

standards are more demanding than the EU’s, they are unlikely to change post-Brexit. Non-

statutory standards allow for a kind of soft pressure to be put on researchers and sponsors to

ensure at least some degree of publicity for trials. As well as indicating who is doing what

kind of work, a public registry would potentially shame research sponsors who do not behave

according to accepted best practice into being more forthcoming with their data.9 The system

would not be foolproof; one might imagine a devious pharmaceutical developer withholding

results from a registered trial to make it look as though an avenue of research is sterile in

order to discourage competitors – but then again, that does take an effort of imagination, and

it can hardly be worse than the situation as it stands.

Clearly, researchers are the focus of these policies. However, some have suggested that the

moral responsibilities can and should be spread more widely. Drazen et al suggest

interestingly that “[p]eople interested in participating in trials should consider only studies

whose sponsors have fully registered them in an appropriate public database and agreed to

publish their results”37. This may be too demanding to be a requirement – the layman may

not know about how reporting works. Moreover, while someone participating in research

may feel resentment if that participation is nixed, it doesn’t follow that she has a duty to

ensure that data are published. Thus there does seem to be an argumentative gap between a

virtuous motivation to participate in research and any kind of responsibility for what happens

to that research. It’s a gap that might be closed; but it does have to be closed before this

suggestion is wholly compelling.

There is a more plausible role to be played by others involved in the research process. As far

back as 1995, Pearn was suggesting that the ethics committees that scrutinise research could

demand publication of results as a condition of allowing the research to go ahead in the first

place,45 and this is reflected in the HRA’s standards.44 Yet while ethics committees may have

some such responsibility, and while – as Begum and Kolstoe have suggested46 – they may

have the capacity to do something about monitoring publication, how publication might be

enforced is another matter.12 This is not least because, by the time researchers decide whether

or not to submit a paper, the research has been done and cannot be undone. Moreover, peer

reviewers may reject a paper for all kinds of reason – Glasziou et al note that research reports

may be so badly written that they are unusable (p. 268)29, and an ethics committee cannot

realistically be expected to monitor that. Hence demands for publication would have to be

backed up by some means to publicise research outcomes outside of journals while

maintaining their quality.

Nevertheless, it is likely that trial registration might be all that could be reasonably required

with any kind of enforceability. Proposed trials could be registered provisionally on an

accessible database even before being seen by ethics committees; registration would therefore

become a prerequisite of research going ahead at all.47 Since all research on humans is ethics

committee approved, and since papers are presumably written with the intention of

publication, all trials would therefore be visible even if they don’t yield any data that could be

submitted to journals. Some means of publicising results that don’t make it to the journals

would remain as a further aspiration.

Journal editors may have a complementary role: they could require that data be shared as a

condition of publication.24 Glasziou et al address the role of publishers head on, noting that

[n]either the profit motive of commercial research nor the academic reward system of non- commercial

research encourage clear, correct, and complete reporting and access to materials, methods, and data of

the research

before adding more optimistically that “[t]his situation can be changed” (p. 273-4)29. In a

similar vein, Chan et al are surely correct to indicate that any solution to the problem of

incomplete reporting must involve the cooperation of researchers, funders, editors, and

regulators (p. 261-2)26. If the problem is systematic, so must be any solution. There is much

more to be said for this kind of approach to the problem than would be inferred from a

motion passed by the BMA in 2013, which asserted that

selective non-publication of unflattering trial data is research misconduct and […] registered medical

practitioners who are believed to have been involved in such conduct should have their fitness-to-

practise assessed by the GMC.48

Asserting that something is misconduct does not make it so; and as we have seen, there are at

least prima facie reasons to withhold trial data that do not indicate unfitness to practise.

These reasons are what make the phenomenon a problem.

Publishing all results can be good public relations for “big pharma”, too, so a sense of honour

might be relevant16,32; and we might look to the insurance industry’s self-denying ordinance

concerning genetic data to see how large companies’ sometimes doing what others would

have the law make them do means that the law doesn’t make them do it. That is: the

commercial sector may come up with data-publicising protocols of its own to anticipate

legislators’ imposing them. For example, the Pharmaceutical Research and Manufacturers of

America and the European Federation of Pharmaceutical Industries and Associations

published a joint statement in 2013 outlining what they called “principles for responsible

clinical trial data sharing”, saying that

[b]iopharmaceutical companies commit to sharing upon request from qualified scientific and medical

researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical

trials in patients for medicines and indications approved in the United States (US) and the European

Union (EU) as necessary for conducting legitimate research. […] Companies will provide access to

patient-level data and other clinical trial information consistent with the principle of safeguarding

patient privacy…49

On the other hand, we would want also to ensure that there is more to these protocols than

PR: virtue may be good PR, but good PR is not the same as virtue.

In this light, it is worth pointing out that, under the terms of the PhARMA/ EFPIA statement, it

is up to outsiders to initiate a request for information, which includes a rationale for the

request. This request is then assessed by a review board put together by the company of

which the request is made. Finally,

[c]ompanies will evaluate, among other things, whether the research proposed has a legitimate

scientific or medical purpose, including whether there is any potential conflict of interest between the

data requestor and the company or competitive use of the data. In the latter case, it may be assumed

that the data requestor may intend to use the company’s patient-level data or other information to help

gain approval of a potentially competing medicine. While companies may enter into agreements to co-

develop medical products, these data sharing Principles are not intended to allow free-riding or

degradation of incentives for companies to invest in biomedical research. Accordingly, it would be

appropriate for companies to refuse to share proprietary information with their competitors.49

Arguably, this creates a conflict of interest in its own right, since the gatekeepers to research

data would be those who are most likely to lose out from data sharing (assuming for the

moment that there are losses to be made). On top of that, by making data-sharing subject to

considerations about commercial interests, the statement might be held to miss the point that

campaigners for more openness about trials have been making; besides, it may be in

everyone’s commercial interests to share data, since that avoids unnecessary duplication of

experiments7,50. Finally, there is little guidance on what a “legitimate scientific or medical

purpose” is. It seems reasonable to think that statements such as this may be little more than

PR in the absence of stronger regulations, whatever their provenance.

Avoiding these problems while retaining some kind of control of information need not be

such a hard task; it is easy enough to imagine a system of accreditation, which would allow

researchers at a signed-up institution (whether commercial or educational) to access full

information by default. This would work in parallel to a system like the one Goldacre

proposes. Exactly how the details of publication or registration might work is beyond the

scope of this paper. It’s enough to say here that the first-order question of whether as much

information from trials as possible should be published in some form is fairly easily settled in

the affirmative, on the understanding that publishing all results would be the ideal. The

remaining second-order question about the best policy to bring this about should not distract

us. There are moral reasons not to publish all clinical trial results; but they are easily

overcome by the moral reasons to publish.

Incidentally: I became aware of the JAMA letter with which I began this survey when an

image of it was posted to Facebook by one of its author’s descendants, whom I happen

vaguely to know. It got over 130 likes, compared to only 2 citations detected by Google

Scholar. What this says about the best way to publicise research, I am not sure.

References

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