Inclusion and Exclusion Criteria of Clinical Trials for Insomnia

Huls, Hendrikje; Abdulahad, Smedra; Mackus, Marlou; Loo, Aurora J. A. E. van de; Roehrs, Timothy; Roth, Thomas; Verster, Joris C.

doi:10.3390/jcm7080206

Cited by 19 publications

(21 citation statements)

References 17 publications

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“…Eligibility criteria are used in trials to recruit participants that are representative of the patient populations who will ultimately receive the medication or intervention in clinical practice, and to ensure the safety and protection of participants [33]. However, some trials use very restrictive eligibility criteria that exclude groups without valid reasons resulting in research samples that do not represent the diversity, symptom complexity or daily challenges of the clinical population [22].…”

Section: Restrictive Eligibility Criteriamentioning

confidence: 99%

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An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

Shepherd

2020

Trials

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Background: There is increasing international recognition that populations included in trials should adequately represent the population treated in clinical practice; however, adults who lack the capacity to provide informed consent are frequently excluded from trials. Addressing the under-representation of groups such as those with impaired capacity to consent is essential to develop effective interventions and provide these groups with the opportunity to benefit from evidence-based care. While the spotlight has been on ensuring only appropriate and justifiable exclusion criteria are used in trials, barriers to the inclusion of adults lacking capacity are multifactorial and complex, and addressing their under-representation will require more than merely widening eligibility criteria. This commentary draws on the literature exploring the inclusion of adults lacking the capacity to consent in research and a number of recent studies to describe the methodological, structural, and systemic factors that have been identified. Main text: A number of potentially modifiable factors contributing to the under-representation of adults lacking the capacity to consent in trials have been identified. In addition to restrictive eligibility criteria, methodological issues include developing appropriate interventions and outcome measures for populations with impaired capacity. Structurally determined factors include the resource-intensive nature of these trials, the requirement for more appropriate research infrastructure, and a lack of interventions to inform and support proxy decision-makers. Systemic factors include the complexities of the legal frameworks, the challenges of ethical review processes, and paternalistic attitudes towards protecting adults with incapacity from the perceived harms of research.

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Section: Restrictive Eligibility Criteriamentioning

confidence: 99%

“…However, some trials use very restrictive eligibility criteria that exclude groups without valid reasons resulting in research samples that do not represent the diversity, symptom complexity or daily challenges of the clinical population [22]. This negatively impacts on the external validity of the trial [33].…”

Section: Restrictive Eligibility Criteriamentioning

confidence: 99%

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

Shepherd

2020

Trials

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“…Unfortunately, applying a large number of eligibility criteria usually results in a considerable number of screening failures (i.e., participants not meeting all criteria for participation) or drop-outs and compliance failures (i.e., participants discontinuing or failing to adhere to the study protocol). This is commonly seen in RCTs [16][17][18]. In addition, a number of people may not participate in the first place when they are informed about the strict lifestyle rules and the hassle of screening procedures (e.g., blood drawings and medical examinations).…”

Section: Recruitment Screening and Test Daysmentioning

confidence: 99%

“…The extent to which RCT participants in drug development are representative for the patient population can therefore be questioned [17,18]. While some 'safety-related' eligibility criteria are obviously necessary, other eligibility criteria (e.g., cut off values for body weight ranges) are often not strongly justified by supporting scientific evidence [16].…”

Section: Recruitment Screening and Test Daysmentioning

confidence: 99%

Advantages and Limitations of Naturalistic Study Designs and Their Implementation in Alcohol Hangover Research

Verster

Loo

Adams

et al. 2019

JCM

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In alcohol hangover research, both naturalistic designs and randomized controlled trials (RCTs) are successfully employed to study the causes, consequences, and treatments of hangovers. Although increasingly applied in both social sciences and medical research, the suitability of naturalistic study designs remains a topic of debate. In both types of study design, screening participants and conducting assessments on-site (e.g., psychometric tests, questionnaires, and biomarker assessments) are usually equally rigorous and follow the same standard operating procedures. However, they differ in the levels of monitoring and restrictions imposed on behaviors of participants before the assessments are conducted (e.g., drinking behaviors resulting in the next day hangover). These behaviors are highly controlled in RCTs and uncontrolled in naturalistic studies. As a result, the largest difference between naturalistic studies and RCTs is their ecological validity, which is usually significantly lower for RCTs and (related to that) the degree of standardization of experimental intervention, which is usually significantly higher for RCTs. In this paper, we specifically discuss the application of naturalistic study designs and RCTs in hangover research. It is debated whether it is necessary to control certain behaviors that precede the hangover state when the aim of a study is to examine the effects of the hangover state itself. If the preceding factors and behaviors are not in the focus of the research question, a naturalistic study design should be preferred whenever one aims to better mimic or understand real-life situations in experimental/intervention studies. Furthermore, to improve the level of control in naturalistic studies, mobile technology can be applied to provide more continuous and objective real-time data, without investigators interfering with participant behaviors or the lab environment impacting on the subjective state. However, for other studies, it may be essential that certain behaviors are strictly controlled. It is, for example, vital that both test days are comparable in terms of consumed alcohol and achieved hangover severity levels when comparing the efficacy and safety of a hangover treatment with a placebo treatment day. This is best accomplished with the help of a highly controlled RCT design.

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“…The patients in phase III clinical trials are included from the treatment target population using eligibility criteria, which often lead to a ‘selected’ trial population that is not always representative of the target population [3–10]. For example, various racial/ethnic populations, elderly people and women were shown to be underrepresented in 59 trials in heart failure [11].…”

Section: Introductionmentioning

confidence: 99%

From Clinical Trial Efficacy to Real-Life Effectiveness: Why Conventional Metrics do not Work

Boissel¹,

Cogny²,

Marko

et al. 2019

Drugs - Real World Outcomes

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Background Randomised, double-blind, clinical trial methodology minimises bias in the measurement of treatment efficacy. However, most phase III trials in non-orphan diseases do not include individuals from the population to whom efficacy findings will be applied in the real world. Thus, a translation process must be used to infer effectiveness for these populations. Current conventional translation processes are not formalised and do not have a clear theoretical or practical base. There is a growing need for accurate translation, both for public health considerations and for supporting the shift towards personalised medicine. Objective Our objective was to assess the results of translation of efficacy data to population efficacy from two simulated clinical trials for two drugs in three populations, using conventional methods. Methods We simulated three populations, two drugs with different efficacies and two trials with different sampling protocols. Results With few exceptions, current translation methods do not result in accurate population effectiveness predictions. The reason for this failure is the non-linearity of the translation method. One of the consequences of this inaccuracy is that pharmacoeconomic and postmarketing surveillance studies based on direct use of clinical trial efficacy metrics are flawed. Conclusion There is a clear need to develop and validate functional and relevant translation approaches for the translation of clinical trial efficacy to the real-world setting. Electronic supplementary material The online version of this article (10.1007/s40801-019-0159-z) contains supplementary material, which is available to authorized users.

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Inclusion and Exclusion Criteria of Clinical Trials for Insomnia

Cited by 19 publications

References 17 publications

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

Advantages and Limitations of Naturalistic Study Designs and Their Implementation in Alcohol Hangover Research

From Clinical Trial Efficacy to Real-Life Effectiveness: Why Conventional Metrics do not Work

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