Clinical trials are a crucial part of medical research, helping to develop new treatments and improve patient care. But what about people with diminished capacity? Can they participate in these important studies? Let’s explore this complex and sensitive topic.
Understanding Diminished Capacity
Diminished capacity refers to a reduced ability to make decisions or understand information. This can affect people with various conditions, including:
- Mental health conditions
- Age-related cognitive decline
- Dementia
- Intellectual disabilities
- Alzheimer’s disease
It should be noted that having one of these (or other) conditions does not automatically disqualify someone from participation in a trial. It requires different treatment with extra attention to their rights and well-being.
Inclusive Research Matters
Involving those with reduced capability in clinical trials is important for several reasons:
- It leads to treatments tailored for their needs.
- It makes sure that drugs are safe and work for everyone.
- It advances equity and inclusion in health research.
As a colleague once said to me (I am paraphrasing here) ” “By including people with diminished capacity in clinical trials, we can gain valuable insights that benefit not only this population but potentially all patients.”
Ethical Considerations
The ethical considerations in conducting clinical trials with people who lack capacity or have impaired capacity include:
Informed Consent Process
Informed consent is a non-negotiable requirement of ethical research. This process may need modifications for those with reduced capacity. Researchers might use:
- Simplified explanations
- Visual aids
- Extra time for discussions
The participant, or in other cases their legal guardian, can give consent.
Risk Assessment
The potential risks and benefits to individuals with compromised capacity must be carefully scrutinised by the researchers. This includes considering:
- Physical risks
- Emotional impact
- Possible disruption to everyday activities
Protection from Exploitation
We must protect the most vulnerable. To do so this includes:
- A robust ethical review of studies
- Advocates being available to safeguard the interests of participants
- Continuous monitoring during the trial period
Challenges in Conducting Trials
Clinical trials with participants who have diminished capacity presents unique challenges:
- Barriers in Communication: Researchers should find efficient modes of communication with participants who may not be skilled at expressing, remembering, or understanding complex information.
- Monitoring Side Effects: Participants may have difficulty articulating side effects accurately, requiring caregivers to monitor more closely.
- Modifying Trial Protocols: Standard trial procedures may require alteration to suit participant needs and capabilities.
- Confirming Understanding: Researchers need to ensure participants understand what is happening during the trial. This may involve ongoing checks and explanations.
Caregivers and Legal Guardians: Important to the wider landscape
Caregivers or legal guardians are central in supporting participants with diminished capacity:
- Decision-Making Support: They provide clinical trial information and support informed decision-making.
- Continuing Communication: Caregivers often act as intermediaries between the participant and research staff.
- Change Detection: They can inform researchers of any changes in the participant’s status or behaviour.
- Caring for the Participant: Throughout the trial, caregivers provide support to maintain participants’ wellness.
Often, some of the best information comes from caregivers working directly with clinicians and researchers, by offering valuable insights, they meet the participants’ needs.”
Innovations in Clinical Trials to Improve Equity
We are using our growing knowledge and innovation to make clinical trials more accessible to those with impaired capacity, through:
- Leveraging technology to streamline data collection
- Trials in standard of care settings, such as care homes
- Creating tailored training for research staff to cope with a patients need
The objective is to make trials more accessible to all individuals across the spectrum.
The Future of Inclusive Clinical Research
As our understanding of diminished capacity evolves, so too does our approach to inclusive clinical research. By carefully addressing ethical concerns, overcoming challenges, and valuing the contributions of all participants, we can create a more equitable and comprehensive landscape for medical studies.
As always, if you’re considering clinical trials, please discuss them with your healthcare provider. They can offer personalised advice and help connect you with the right clinical studies near you.
Equally important, by incorporating individuals with reduced capacity in clinical trials, we not only improve medical science through accurate representation but also create healthcare and social awareness that includes everyone.