Demographic characteristics

A total of 45 people completed the survey. Of these, 26 (58%) were disabled people, 8 (18%) were carers/family members and 11 (24%) were trial staff. To tabulate results, numeric characters were assigned for disabled people (Disabled person 1–26), carers (Carer 1–Carer 8) and clinical trial staff (Staff 1–Staff 11). A focus group was conducted with five disabled people. To ensure anonymity, participants were assigned random alphanumeric characters (Participant 1–Participant 5). Table 1 explains the number of responses we received and the detailed characteristics of the survey respondents. Detailed demographic characteristics of focus group participants are available in Additional File 3.

Table 1 Numbers of survey responses received

The following sections discuss the results from the survey and focus group in an integrated manner. Tables 2 and Table 3 provide the summary statistics derived from the survey’s closed-ended questions. The results for each of these elements are elaborated upon in the following section. Additional file 4 provides supplementary information on the frequencies of themes derived from the focus group discussion.

Table 2 Descriptive results from survey multiple choice questions (disabled people and carers/family members)Table 3 Descriptive results from survey multiple choice questions (clinical trials staff)Theme 1: Opportunity barrier—inadequate recruitment strategy and ambiguous eligibility criteria (a)

Inadequate recruitment strategy

Survey closed-ended questions

There were gaps in participants’ and researchers’ awareness and perceptions regarding clinical trial recruitment. The survey results show that 47% of disabled people and carers/family members said that advertisements were not fully accessible and understandable. In contrast, 55% of the staff involved in clinical trials reported that the trial venue was accessible to participants, while a higher percentage, 64%, reported that the advertisement for the trial call was accessible to participants.

Survey open-ended questions

A response from one disabled person pointed out that the current recruitment strategy for clinical trials is predominantly led by clinicians. This approach tends to limit inclusivity for people outside of the clinic, as the target population is often too selectively chosen. To reach disabled people, different recruitment tactics should be employed, such as approaching local communities, local media and pharmacies and using relatable promotional materials. For example, disabled people described what they thought would be an effective approach for enhancing recruitment.

“Use ‘real’ case examples of disabled people with different impairments and ‘conditions’ to recruit” [Disabled person 19].

Focus group discussion

Focus group participants highlighted how information tends to be less accessible to disabled people. They mentioned that clinical trial participants are mainly recruited directly from clinics or hospitals and trials are often not openly advertised. They underscored a need for broader access to information on how people can participate and which clinical trials are currently ongoing. Additionally, they highlighted that disabled people are more likely to be overlooked as part of the target audience for clinical trials.

(b)

Ambiguous eligibility criteria

Survey closed-ended questions

Sixty-four of staff perceived that certain groups of disabled people are excluded from participating in clinical trials. Eight-two percent of staff indicated that eligibility criteria for disabled people are sometimes ambiguous and lead disabled people to be unnecessarily excluded from participating in clinical trials.

Survey open-ended questions

It was reported, mainly by clinical trial staff, that the eligibility criteria for disabled people largely depend on the discretion of the principal investigators and co-investigators. Clinical trial staff who responded to the survey questionnaire described the eligibility criteria of many clinical trials as a “grey area” for recruiting disabled people.

“This is ambiguous and leaves it up to the Investigator to interpret, they may be over cautious and exclude people ‘to be on the safe side’ when in fact these people are eligible” [Staff 2].

To improve this, respondents suggested that tailored inclusion and exclusion criteria for disabled people should be used, and disability and capacity to consent should be assessed at the individual level. However, it was also mentioned that implementing such adjustments takes time and financial consideration.

“To allow for patients with fluctuating capacity; however, they may then not be able to give informed consent if it is a more complex trial. The patients would have to be assessed individually to ensure they can retain and understand the information to give consent” [Staff 3].

Focus group discussion

The focus group highlighted that the current eligibility criteria of clinical trial designs are not grounded in “realistic expectations” of disabled people. Disabled people also mentioned that researchers feared that by including a small number of disabled people would hamper statistics and potentially introduce confounding factors in the model.

“Funders, e.g., NIHR, need to recognise the requirements for inclusivity can be unrealistic” [Participant 2].

Theme 2: Awareness barrier—perception of disabilities Survey closed-ended questions

Ninety-four percent of disabled people and carers/family members stated that their disability interfered with their activities of daily living, and 88% of them said it affected their communication. Of these, 26% of disabled people and carers/family members said their daily tasks were always affected.

Survey open-ended questions

Disabled people who responded to the open-ended questions in the survey stated that the perception of disability that clinical trial staff have remains superficial and sometimes over-medicalised, thereby highlighting the need to understand better how having a disability affects peoples’ daily lives in different ways. It is often challenging to fully understand the extent of disability, particularly in individuals with invisible disabilities (conditions that are not immediately obvious, e.g., chronic pain, hearing loss, mental health conditions). These individuals run the risk of not being perceived as disabled.

“People think that I’m lazy, that losing weight and exercise would solve all my problems. They do not understand the pain with every single task” [Disabled person 10].

Focus group discussion

In addition to the survey respondents, focus group participants highlighted that invisible disabilities and multiple conditions are often not recognised in the research. Participant 5 described the importance of invisible and multiple disabilities being recognised, along with her experience of having a visual impairment but not being recognised by others as having a disability. Thus, understanding different dimensions of disability by staff and sponsors involved in clinical trials is essential; this also relates to whether support and adjustments are available to disabled people.

“Visual impairments fall off the radar, disabilities aren’t necessarily declared. And having multiple conditions is not always recognised in surveys or trials” [Participant 5].

Theme 3: Acceptance/refusal barrier—available support and adjustment, sharing results (a)

Available support and adjustment

Survey closed-ended questions

Although 82% of staff were aware that the assessments and site visits could be burdensome for disabled people, only 42% of disabled people had been asked about the need for support/adjustment when participating in clinical trials.

Survey open-ended questions

Survey respondents highlighted that having a disability had several consequences in the lives of disabled people and their participation in clinical trials — these burdens on disabled people include time and financial, physical and mental constraints. Twenty-one percent of survey respondents stated that they were not asked in advance about the support and help they would need when taking part. Although the need for support is recognised among staff, staff responses revealed that this is subject to resources and financial constraints, such as whether funders are willing to support such as sign language interpreters and cover travel expenses.

“For me, length of travel, accessibility to trial rooms, and how long the trial might take would all be factors, and I understand these factors may well be outside the researchers’ scope” [Disabled person 12].

Focus group discussion

Similarly, disabled people who participated in the focus group discussed the need for providers to recognise that participating in clinical trials, in addition to their usual care and treatment, is not easy and that they would need to make considerable preparation to participate, such as transport, whether the venue clinic has soft seating, and whether there are places for refreshments and breaks. They highlighted that support and adjustment for participation in clinical trials need to reflect the realities and needs of people with disabilities more accurately.

“I would like to ‘do my bit’, I might be in a unique position because of my disability but also can’t do much because of my disability” [Participant 4].

“It is hard work, you always have to plan, plan, plan. If I need to go to the shops, how far is it, can I get there, will I need the bathroom. All these worries make it difficult before you even leave the house” [Disabled person 5].

(b)

Sharing results

Survey closed-ended questions

Interesting data on the sharing of clinical trial results were obtained. Out of the 19 participants in the study who indicated they had participated in clinical trials, only seven (37%) of the carers/family members and disabled individuals were informed about the trial results.

Survey open-ended questions

The clinical trial staff did not raise any issues regarding sharing results and content. However, the disabled people and carers who responded to the questionnaire highlighted this issue. The following quote stated that the results were unacceptable as the participants felt they had been misrepresented. This highlights the unpicked issue of “how” and “when” results should be shared with disabled people/carers.

“I received information on the study results but not before I had read about it in the national press, and the way that the results were presented made me feel that I had been an inadequate mother….” [Carer 8].