Are investigators’ access to trial data and rights to publish restricted and are potential trial participants informed about this? A comparison of trial protocols and informed consent materials

Abstract Objectives To determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators. Methods Cohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvement approved by ethics committees in Denmark. The main outcome measures used were: proportion of trials where data was owned by the industry partner, where the investigators right to publish were constrained and if this was mentioned in informed consent documents, and where the industry partner could review data while the trial was ongoing and stop the trial early. Results The industry partner owned all data in 20 trials (48%) and in 16 trials (38%) it was unclear. Publication constraints were described for 30 trials (71%) and this was not communicated to trial participants in informed consent documents in any of the trials. In eight trials (19%) the industry partner could review data during the trial, for 20 trials (48%) it was unclear. The industry partner could stop the trial early without any specific reason in 23 trials (55%). Conclusions Publication constraints are common, and data is often owned by industry partners. This is rarely communicated to trial participants. Such constraints might contribute to problems with selective outcome reporting. Patients should be fully informed about these aspects of trial conduct.

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PROTOCOL: Are clinical trial participants informed about potential benefits and harms? A comparison of informed consent materials and trial protocols

10.1101/2020.05.18.20100917 ◽

2020 ◽

Author(s):

Asger Sand Paludan-Mueller ◽

Karsten J Joergensen ◽

Peter C Goetzsche

Keyword(s):

Clinical Trial ◽

Informed Consent ◽

Trial Protocols ◽

Potential Benefits ◽

Trial Participants

This is a protocol for the project entitled: 'Are clinical trial participants informed about potential benefits and harms? A comparison of informed consent materials and trial protocols.'

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PROTOCOL: Are investigators' access to trial data and rights to publish restricted and are trial participants informed about this? A comparison of trial protocols and informed consent materials.

10.1101/2020.08.13.20174177 ◽

2020 ◽

Author(s):

Asger Sand Paludan-Muller ◽

Karsten J Joergensen ◽

Peter C Goetszche

Keyword(s):

Informed Consent ◽

Trial Data ◽

Trial Protocols ◽

Trial Participants

This is a protocol for the project entitled: "Are investigators' access to trial data and rights to publish restricted and are trial participants informed about this? A comparison of trial protocols and informed consent materials"

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P092 NICE biologics pathways for inflammatory arthritis exhibit regional variability due to modification by CCG’s: results from a national survey of pathways in England

Rheumatology ◽

10.1093/rheumatology/keab247.090 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

Jatin Mistry ◽

Diane Hill ◽

Ailsa Bosworth ◽

Arvind Kaul

Keyword(s):

Inflammatory Arthritis ◽

Good Practice ◽

National Study ◽

Freedom Of Information ◽

Inadequate Response ◽

Limited Sample ◽

Regional Variability ◽

Nice Guidance ◽

Information Requests ◽

Individual Funding

Abstract Background/Aims NICE publishes guidance underpinned by act of Parliament and legally enforceable, on the use of biological therapies in the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) which should allow harmonisation of access independent of region. However, sufficient guidance is not provided on the use of sequential biologics nor is a numerical cap placed on the number of biologics a patient can attempt if they have had an inadequate response. We have previously reported that in a limited sample, Clinical Commissioning Groups (CCGs) interpret NICE guidance variably and restrict access to NICE approved treatments depending on geography, the so-called “postcode lottery”. We determined the variability of biologics pathways in all CCG’s in England to examine whether a potentially unfair postcode lottery exists for sequential biologics use. Methods All 135 England CCGs covering over 55 million people, were sent Freedom of Information requests, for their biologic pathways for RA, PsA and AS. Where CCGs did not have this information, the relevant acute trusts were contacted, with responses recorded under that CCG. For every CCG the local biologics pathways were examined for detail on the number and type of biologics commissioned before an Individual Funding Request was needed. “No Cap” was recorded if CCG’s responded with no restriction on the number of biologics. Results Responses were obtained from 124/135 CCG’s for RA, 122/135 for PsA and AS, all covering an estimated population in excess of 45 million people. For RA, 55% CCG’s had no cap on the number of commissioned RA biologics. 45% had a variable cap from 3 to 6 commissioned biologics. For PsA, the figures were 54% with no cap and 46% with variable capping between 2-5 biologics allowed, for AS the figures were 51% and 49% respectively. In total this represented 41 different local pathways for RA, 29 different pathways for PsA and in AS where fewer biologics choices exist, 25 different pathways depending on CCG and location. Conclusion There is wide regional variation in the interpretation of NICE guidance by CCG’s resulting in many different local pathways depending on geography. Approximately 50% of pathways restricted biologics prescribing by mandating the type and sequence of biologics used, potentially compromising patient care and delaying treatment by requiring an IFR for a NICE approved biologic. Moreover, pathways varied as to which biologics could be used at any point of management by region as well. As exemplars of good practice, approximately 50% of CCG’s had no cap, allowing clinical freedom to prescribe the most appropriate biologic. The results of this national study demonstrate the variability of biologics pathways in many areas of England ensuring a postcode lottery still exists in many regions. Disclosure J. Mistry: None. D. Hill: None. A. Bosworth: None. A. Kaul: None.

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Cyber-Situational Awarenss in Clinical Trials Using Wearable Device Technology

Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care ◽

10.1177/2327857921101011 ◽

2021 ◽

Vol 10 (1) ◽

pp. 33-36

Author(s):

Elizabeth A. Johnson ◽

Jane M. Carrington

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Best Practices ◽

Situational Awareness ◽

Implantable Devices ◽

Wearable Device ◽

Sleep Habits ◽

Privacy Issues ◽

Trial Participants ◽

Device Technology

It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness (CSA) as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age. This paper reviews integrated elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.

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The use of freedom of information requests in medical audit and research

British Journal of Hospital Medicine ◽

10.12968/hmed.2016.77.7.382 ◽

2016 ◽

Vol 77 (7) ◽

pp. 382-383

Author(s):

Samuel S Folkard ◽

Arun Ray ◽

David Ricketts ◽

Benedict A Rogers

Keyword(s):

Freedom Of Information ◽

Medical Audit ◽

Information Requests

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Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

BMC Medical Ethics ◽

10.1186/s12910-020-00536-9 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Daria Kim ◽

Joerg Hasford

Keyword(s):

Clinical Trials ◽

Health Risks ◽

Ethics Committees ◽

Medical Community ◽

Significant Extent ◽

Regulatory Requirements ◽

Trial Participants ◽

Clinical Trials Regulation ◽

Clinical Trial Regulation ◽

The Eu

Abstract The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

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