Public interest in clinical study data and the right to privacy

SpotOn London: November 2014

Dr Trish Groves

Head of Research, BMJ

& Editor-in-chief BMJ Open

@trished

Competing interests

I’m editor in chief of BMJ Open and Head of Research at BMJ, awholly owned subsidiary of the BMA

BMJ (the company) receives revenues from drug & device manufacturersthrough advertising, reprint sales, & sponsorship

I receive a bonus based partly on the financial performance of TheBMJ. The BMJ is an open access journal that charges author feesfor publication of research articles, as does BMJ Open

The BMJ was a co-founder of the AllTrials campaign

The BMJ is campaigning for reproducible research

Advice to patients entering trials

Agree to participate in a clinical trial only if:

(1) the study protocol has been registered and made publicly available;

(2) the protocol refers to systematic reviews of existing evidence showing that the trial is justified; and

(3) you receive a written assurance that the full study results will be published and sent to all participants who indicate that they wish to receive them.

Evans I, Thornton H, Chalmers I, Glasziou P. Testing treatments. Pinter and Martin, 2011 www.testingtreatments.org

Should researchers share patient data?

To maximise fidelity of evidencebase ...and:• allow testing of secondary

hypotheses • aid design of future trials• facilitate individual patient

data meta-analysis • aid developing/evaluating

novel statistical methods• ensure analyses can be

reproduced and checked• provide incentive to ensure

accuracy of dataset• reduce deliberate misconduct

Vickers A. Trials 2006;7:15 doi:10.1186/1745-6215-7-15

• How to minimize risks to privacy and confidentiality?

• Are anonymization or de-identification methodologies sufficient?

• Could re-identification of trial participants ever be beneficial?

• Any instances of re-identification of participants, with what impacts?

Which data might reveal identity?

In a collection of patient observations used to produce summary results of a study:

• identifying information is either direct or indirect

• publication of any direct identifiers could lead to personal identification

• no indirect identifier alone would point to individual, but dataset with several indirect identifiers could

• dataset including at least 3 indirect identifiers should be assessed by independent researcher or ethics committee to evaluate risk to privacy

Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG.Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers BMJ 2010; 340:c181

Clinical study identifiersIndirect

Place of treatment, name of doctor

Sex, ethnicity

Year of birth or age

Place of birth

Socioeconomic data eg occupation, income

Household & family composition

Sensitive data eg illicit drug use

Rare disease or unusual treatment

Anthropometry eg height, weight, BMI

Number of pregnancies

Small denominators—population size of <100

Very small numerators—event counts of <3

Verbatim quotes, transcripts of interviews

Direct

Name/initials

Address with full/partial postcode

Phone/fax/email

Unique ID eg study participant number

Vehicle registration number

Medical device ID (eg hip implant serial no.)

Website URL

Biometric data

Photo of face or other unique image eg tattoo

Audio- or videotaped interview

Relatives’ names

Personal dates eg D.O.B.

• For all new centralised drug marketing authorisations submitted after 1 January 2015 the European Medicines Agency (EMA) will provide public access to the core content of clinical study reports and will allow researchers to use the reports for further analyses

• After further debate on the ethical and technical challenges, the agency intends to also provide access to anonymised individual patient data

https://www.clinicalstudydatarequest.com/

AllTrials campaign

THE PROBLEM

Thousands of clinical trials have not reported results.

Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials needlessly repeated.

All Trials Registered | All Results Reported

#AllTrials www.alltrials.net

WHAT CAN YOU DO?

• Join the >81,000 individuals who have signed the petition for all clinical trials to be registered and the results reported.

• Ask your organisation to join the campaign (520+ organisations have joined so far)

• Write a feature, blog post, editorial, or tell your members in your organisation’s newsletter

• Ask your friends, family, and colleagues to sign up

• Donate to the campaign

• Get involved in other ways via www.alltrials.net

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@trished tgroves@bmj.com