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Concept: Trial

176

We report information about an unpublished 1970s study (“8-way” Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial’s findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published.

Concepts: Epidemiology, Randomized controlled trial, ClinicalTrials.gov, Efficacy, The Trial, Nausea, Trial, Morning sickness

170

Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation.The ‘open access’ approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism.The ‘restricted access’ approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who ‘needs to know’ about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial.It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results.

Concepts: Clinical trial, ClinicalTrials.gov, Law, Clinical research, The Trial, Trial, Intellectual property law, Legal documents

31

In recent decades, social scientists have shown that the reliability of eyewitness identifications is much worse than laypersons tend to believe. Although courts have only recently begun to react to this evidence, the New Jersey judiciary has reformed its jury instructions to notify jurors about the frailties of human memory, the potential for lineup administrators to nudge witnesses towards suspects that they police have already identified, and the advantages of alternative lineup procedures, including blinding of the administrator. This experiment tested the efficacy of New Jersey’s jury instruction. In a 2×2 between-subjects design, mock jurors (N = 335) watched a 35-minute murder trial, wherein identification quality was either “weak” or “strong” and either the New Jersey or a “standard” instruction was delivered. Jurors were more than twice as likely to convict when the standard instruction was used (OR = 2.55; 95% CI = 1.37-4.89, p < 0.001). The New Jersey instruction, however, did not improve juror's ability to discern quality; rather, jurors receiving those instructions indiscriminatingly discounted "weak" and "strong" testimony in equal measure.

Concepts: Supreme Court of the United States, Law, Jury, Trial, Judge, Court, Jury instructions, Legal procedure

13

The UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Units (CTUs) Network aims to support high-quality, efficient and sustainable clinical trials research in the UK. To better understand the challenges in efficient trial conduct, and to help prioritise tackling these challenges, we surveyed CTU staff. The aim was to identify important inefficiencies during two key stages of the trial conduct life cycle: (i) from grant award to first participant, (ii) from first participant to reporting of final results.

Concepts: Clinical trial, Medical statistics, ClinicalTrials.gov, United Kingdom, Clinical research, The Trial, Trial, Harold Pinter

11

Deborah Zarin and Tony Tse of ClinicalTrials.Gov consider how sharing individual participant data can and cannot help improve the reporting of clinical trials.

Concepts: Clinical trial, ClinicalTrials.gov, The Trial, Trial

9

How objective are forensic experts when they are retained by one of the opposing sides in an adversarial legal proceeding? Despite long-standing concerns from within the legal system, little is known about whether experts can provide opinions unbiased by the side that retained them. In this experiment, we paid 108 forensic psychologists and psychiatrists to review the same offender case files, but deceived some to believe that they were consulting for the defense and some to believe that they were consulting for the prosecution. Participants scored each offender on two commonly used, well-researched risk-assessment instruments. Those who believed they were working for the prosecution tended to assign higher risk scores to offenders, whereas those who believed they were working for the defense tended to assign lower risk scores to the same offenders; the effect sizes (d) ranged up to 0.85. The results provide strong evidence of an allegiance effect among some forensic experts in adversarial legal proceedings.

Concepts: Critical thinking, 2002 albums, Law, Meta-analysis, Jury, Trial, Common law, Civil law

8

Previous meta-analyses have found that exercise prevents falls in older people. This study aimed to test whether this effect is still present when new trials are added, and it explores whether characteristics of the trial design, sample or intervention are associated with greater fall prevention effects.

Concepts: Evidence-based medicine, Systematic review, Effect size, The Trial, Geriatrics, Meta-analysis, Publication bias, Trial

7

Selection bias occurs when recruiters selectively enrol patients into the trial based on what the next treatment allocation is likely to be. This can occur even if appropriate allocation concealment is used if recruiters can guess the next treatment assignment with some degree of accuracy. This typically occurs in unblinded trials when restricted randomisation is implemented to force the number of patients in each arm or within each centre to be the same. Several methods to reduce the risk of selection bias have been suggested; however, it is unclear how often these techniques are used in practice.

Concepts: Randomized controlled trial, The Trial, Publication bias, Trial, Bias

5

Pragmatic trials of implementation interventions focus on evaluating whether an intervention changes professional behaviour under real-world conditions rather than investigating the mechanism through which change occurs. Theory-based process evaluations conducted alongside pragmatic randomised trials address this by assessing whether the intervention changes theoretical constructs proposed to mediate change. The Ontario Printed Educational Materials (PEM) cluster trial was designed to increase family physicians' guideline-recommended prescription of thiazide diuretics. The trial found no intervention effect. Using the theory of planned behaviour (TPB), we hypothesised that changes in thiazide prescribing would be reflected in changes in intention, consistent with changes in attitude and subjective norm, with no change to their perceived behavioural control (PBC), and tested this alongside the RCT.

Concepts: Psychology, Evaluation, Randomized controlled trial, Pharmaceutical industry, The Trial, Diuretic, Thiazide, Trial

5

Some reasons for registering trials might be considered as self-serving, such as satisfying the requirements of a journal in which the researchers wish to publish their eventual findings or publicising the trial to boost recruitment. Registry entries also help others, including systematic reviewers, to know about ongoing or unpublished studies and contribute to reducing research waste by making it clear what studies are ongoing. Other sources of research waste include inconsistency in outcome measurement across trials in the same area, missing data on important outcomes from some trials, and selective reporting of outcomes. One way to reduce this waste is through the use of core outcome sets: standardised sets of outcomes for research in specific areas of health and social care. These do not restrict the outcomes that will be measured, but provide the minimum to include if a trial is to be of the most use to potential users. We propose that trial registries, such as ISRCTN, encourage researchers to note their use of a core outcome set in their entry. This will help people searching for trials and those worried about selective reporting in closed trials. Trial registries can facilitate these efforts to make new trials as useful as possible and reduce waste. The outcomes section in the entry could prompt the researcher to consider using a core outcome set and facilitate the specification of that core outcome set and its component outcomes through linking to the original core outcome set. In doing this, registries will contribute to the global effort to ensure that trials answer important uncertainties, can be brought together in systematic reviews, and better serve their ultimate aim of improving health and well-being through improving health and social care.

Concepts: Game theory, Systematic review, Research, The Trial, Outcome, Trial, Researcher, Register