Publishing information about ongoing clinical trials for patients
BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c725 (Published 24 February 2010) Cite this as: BMJ 2010;340:c725
All rapid responses
We read with interest the article of Godlee and Chalmers[1] on
patients' information about ongoing clinical trial. Like these authors, we
are convinced that this informing is crucial and that it would be done
only if investigators enter information once instead of duplicating
information.
However we would like to emphasise that information should nevertheless be
entered a second time when the trial results become available. Informing
patients about trial results is not routinely done.[2] Even if Internet is
not the preferred source of information for patients that had participated
in a trial,[3] it could be a good way to inform patients who want to take
part in clinical trials and general population. Transparency concerns the
trial protocol but also its results.[4]
References
[1] Godlee F, Chalmers I. Publishing information about ongoing
clinical trials for patients. BMJ 2010;340:c725.
[2] Dalal HM, Wingham J, Evans P, Taylor R, Campbell J. Patients
deserve more than a "Thank you" BMJ 2009;339:b4522.
[3] Mancini J, Genre D, Dalenc F, Ferrero JM, Kerbrat P, Martin AL,
et al. Participants’ uptake of clinical trial results: a randomised
experiment. Br J Cancer in press (doi:10.1038/sj.bjc.6605592).
[4] Anonymous. Establishing transparency to restore trust in clinical
trials. Lancet Neurol 2006;5(8):645.
Competing interests:
None declared
Competing interests: No competing interests
This article notes that the "continuing lack of information to help
people decide whether and how to take part in research is surprising : not
only "surprising " but also dangerous.
My experience and research has shown that there can be no "free access to
information about ongoing research" because the pharmaceutical industry
,apparently aided by the MHRA ,does not permit it. In correspondence with
the
MHRA I discovered that information contained in the trial patient
information sheet ( which forms the contract between the volunteer and the
sponsoring company ) can be " abridged ": How far may this abridgement go
? The information I was given was shown to be selective and there was no
mention of trials being run concurrently with the one that I was on, and
there was no mention of previous trials.
Competing interests:
None declared
Competing interests: No competing interests
We firmly support the call by Drs Godlee and Chalmers for progress to
be made in providing easier access for the public to information on
research trials. Inadequate or slow recruitment of patients to clinical
studies is a long-standing problem that affects the majority of studies.
Although many factors influence this issue, public awareness of clinical
research is a major one.
Using television, radio and newspaper advertisements involving
leading clinical researchers from across Scotland we conducted a media
campaign called “Get Randomised” during a 3-month period in 2009 to try to
promote the public profile of clinical research (1) . Using opinion polls
before and after the campaign we showed a significant increase in the
degree of public awareness in research trials, but no difference in public
attitudes to actual engagement in research.
Our pilot campaign lacked an ingredient well recognised by the
advertising industry in whose territory we were dabbling – a “Call to
Action”. In the commercial world this crucial next step involves
converting the interest generated by the advertisement into, usually, a
sale of the product on show. We were unable to provide a suitable
destination for our audience, even the interested ones, to go and find out
about specific research that might have been relevant to them, and this is
what we badly need.
The information needs to be easily understood - a look at the “lay
summaries” on the NRES site (www.nres.npsa.nhs.uk/researchsummaries) gives
a flavour of how much a gulf can exist between medical and ordinary
language, even when one is trying to be comprehendible. The information
needs also to be navigable, so that potential research participants are
guided easily and well to information on studies that are relevant to
them. A comprehensive internet-based service is the logical form this new
facility should take. Pulling together information from existing databases
could be part of how one might go about this, but it would indeed still be
a large undertaking.
Failure to meet recruitment targets is a serious threat to any
clinical research study. Making it much easier for researchers and the
public to meet up could go a long way to addressing this difficulty.
(1) Mackenzie I S et al. Promoting public awareness of randomised
clinical trials using the media: the ‘Get Randomised’ campaign. B J Clin
Pharmacol 2010 69:2;128-135
Competing interests:
None declared
Competing interests: No competing interests
Clinician engagement is critical to public engagement with clinical trials
Five years on from Godlee and Chalmers’ advocacy of greater information for patients regarding ongoing clinical trials [1], we have conducted research indicating that addressing clinicians’ information needs and engagement with local research is as critical, if not more so in enabling research participation.
Access to the latest treatments and diagnostic tests through participation in research studies is a right for all patients under the NHS constitution, with clear instruction to providers to enable access to research studies [2]. Similarly, the National Institute of Health Research (NIHR) seeks to ensure that all NHS patients are made aware of research of relevance to them [3] . Despite this, and several public polls reporting 90-95% support for clinical research, NHS clinical trials in England recruited only 0.94% of the total population in 2013-14[4,5,6,7], and experience on the ground across the NHS is that full, timely recruitment to open trials is challenging.
To explore factors in this disconnect between public opinion and research participation we have conducted the first detailed, regional-scale survey of public and clinician opinion to identify key perceptions, motivations and barriers to trial participation.
Following a literature review and pilot study to design the quantitative questionnaire, we conducted 1101 telephone interviews with adults in Wessex; Dorset, South Wiltshire, Hampshire and Isle of Wight (representative of the population by key demographics such as gender, age and location), 30 in-depth follow-up interviews and carried out interviews of 26 clinicians including hospital Trust consultants, nurses, and primary care physicians. The full and summary reports can be downloaded from www.uhs.nhs.uk/engagingforparticipation .
The public interviews showed that only 10% had participated in research at some point in their life despite 90% of public respondents agreeing that it is important for the NHS to support research, and 47% saying they would be likely to take part in trials if approached. Importantly, 80% of people who have taken part in clinical research would recommend taking part to a friend or family member, whilst around 44% of people who know someone who has taken part in clinical research said that they are more likely to participate as a result.
Clinical trial participation was discussed in only 5% of medical consultations in the previous 12 months, whilst only 15% of public respondents could recall being asked about trial participation by a clinician at any point in their life.
Motivations for participation were focussed on the personal health benefits for the individual, whilst the principal barriers were perceived risks of harm and/or being subjected to the ‘unknown’. In addition, time commitments and time off work were also identified as significant barriers to participation. Of particular interest to us was the fact that respondents reported that they would be more likely to take part in research if their own NHS clinician was explaining the research.
Through in-depth interviews with clinicians, a clear perception emerged amongst primary care physicians and hospital consultants that their peers divide into those that are ‘researchers ‘ (an academically orientated minority), and those that are ‘practitioners’, with these groups having separate motivations and priorities.
Whilst ‘practitioners’ are supportive and positive towards research, their involvement generally extended no further than providing referral. Respondents said that a lack of accessible and reliable local trial information was a barrier to referral or discussion, and that such tools would increase the likelihood of discussing research with patients.
Time and workload pressures were almost universally cited as barriers to discussion of research with patients, both in terms of clinicians finding and familiarising themselves with the necessary information, and in building such discussions into consultations.
Bureaucratic burdens associated with research governance were also noted to be ongoing barriers to direct involvement in clinical research, although we did not explore whether this is linked to depth of knowledge of the resources available locally.
The finding that 95% of clinicians are not currently discussing trial treatment options with a clearly willing public is critical if increased engagement with research is to be achieved. Our study has confirmed the inherent trust placed in NHS clinicians to deliver clinical trial information [5], suggesting that interventions focused on clinical consultations and patients’ immediate health concerns could dramatically increase engagement with relevant research.
Detailed recommendations can be found in the reports, however it is clear that NIHR regional resources could be further targeted to support NHS clinicians’ engagement with local clinical trials, and to explore management and education interventions to make communication with patients about trials a routine part of all NHS consultations.
Additionally, altered clinical research staff work times and practices to provide greater flexibility to allow potential participants to fit research participation around work and home commitments.
References
[1] Godlee F, Chalmers I. Publishing information about ongoing
clinical trials for patients. BMJ 2010;340:c725.
[2] NHS Constitution, 2013 http://www.nhs.uk/choiceintheNHS/Rightsandpledges/NHSConstitution/Docume...
the-nhs-constitution-for-england-2013.pdf
[3] National Institute for Health Research Annual Report 2010/11 www.gov.uk/government/uploads/system/uploads/attachment_data/file/215416...
[4] IPSOS-MORI / Association of Medical research Cahrities J11-02572 Public support for research in the NHS, http://www.ipsos-mori.com/researchpublications/researcharchive/2811/Publ...
[5] Butt, S., Clery, E., Abeywardana, V., and Phillips, M. (2010). Wellcome Trust Monitor 1. London: Wellcome Trust.
[6] NIHR Clinical Research Network Annual Report 2013/14
http://www.crn.nihr.ac.uk/wp-content/uploads/About%20the%20CRN/13_14%20A...
[7] Office for National Statistics mid 2013 UK population estimates http://www.ons.gov.uk/ons/rel/pop-estimate/population-estimates-for-uk--...
Competing interests: No competing interests