Potential Barriers and Challenges

Planning an ID trial may take longer than a mainstream trial. Because of the range of needs, abilities and disabilities of potential participants, their carers or their families, you may need to make a series of adjustments to your recruitment resources, your intervention plan and/or your outcome measures. This may require additional time, expertise and resources.
Not everyone agrees that RCTs can, or should, be conducted with people with intellectual or cognitive disabilities. Some people do not fully understand the RCT methodology. Be prepared, you may encounter resistance from fellow research, academic or clinical colleagues regarding the utility of conducting RCTs with people with intellectual disabilities.
Because of the specialist nature of researching with people with disabilities, your funding application is more likely to be successful if it includes personnel with a range of specialist skill sets; including statisticians, epidemiologists, health economists, qualitative experts, user involvement, and someone who has direct experience recruiting and researching in this field.
Although there are many researchers working world-wide to help improve the lives of people with intellectual disabilities, very few of them have experience in conducting RCTs. It may be a challenge then to gather an effective team with the required RCT skill set.

Reasonable adjustments in an ID trial require funding for additional time and resources (e.g. extra staff, easy read documents and other communication aids, specialist equipment); some funders do not always understand or appreciate the importance and cost of these adjustments.
.

planning