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Methodology Monday January Roundup
In January's #MethodologyMonday Roundup we close the series on pregnant women and open a new focus on disability.
The last article in our #MethodologyMonday series on pregnant women comes from Ren, Bremer and Pawlyk. They take us through the recent history of clinical trials and research during pregnancy through to the development of the Obstetric-Fetal Pharmacology Research Units in the US and the impact of such centres. The article also covers elements related to the physiological changes that affect drug disposition in pregnancy as well as pharmacometrics tools in maternal pharmacological research.
For the remainder of the month, #MethodologyMonday will focus on disability. To open the topic, we share the scoping review by Shariq and colleagues on barriers and facilitators to the recruitment of disabled people to clinical trials. The work brought about 5 themes: risk vs benefit, design and management of recruitment protocol; balancing internal and external validity; consent and ethics; and systemic factors. The review brings about a number of key findings and shares key principles to be implemented in future research to support the inclusion of persons with disabilities.
A second scoping review covering the link between people with disabilities and their exclusion from trials by Camanni et al is the focus of the next #MethodologyMonday. With over 2500 trials analysed in the review, the reader is given a clear quantification of the extent of the problem. It looks more closely at the categories of disability with higher rates of exclusion and the appropriateness of the exclusions identified in relation to the primary objective of the trials. Through their review, the authors highlight the importance of inclusive design, which enables people with disabilities to become active participants in studies that concern them.
To conclude this month's #MethodologyMonday discussion on the inclusion of people with disabilities, we share this article by McDonald and colleagues on the inclusion of adults with intellectual disability in NIH-funded (US) clinical trials. Spoiler alert, they found a substantial cause for concern: adults with intellectual disability experienced widespread exclusion. With rare exception, no studies directly included adults with intellectual disability and ¾ of the NIH-funded trials had eligibility criteria that could exclude this population.
