Dr. Michael F. Bone

Communication and

Consent in Clinical Trials

Dealing with incapacitated

participants

Dr. Michael F. Bone

Recommendations

How is participant understanding of written PIS influenced by oral augmentation?

How can potential participants be helped? – Reflection

RECs expect trialists to evaluate information giving – Currently adherence to national guidelines??

Dr. Michael F. Bone

Decisional-making impairment

and dementia

Standard developed initially with a focus on the

capacity to consent to treatment not clinical research

Ability to understand relevant information,

Ability to appreciate the situation and its

consequences

Ability to manipulate information rationally

Laurence Hugonot-Diener 2009

Competency to consent have been defined as the ability to Understand relevant information

Weight the benefits and risks of the proposed procedures

Reach a reasonable decision

Express a choice

The Decision-making Capacity

Physicians have not been well prepared to make competency

decision.

Physicians have difficulty assessing decision making

capacity in older adults and rely almost exclusively on

subjective clinical impressions

Need for objective standardized assessment instrument to

help physicians

Talking about Trials

Lesley Fallowfield

Aims of Project (Jenkins et al, BMJ,2005)

to produce a set of educational training videos, CD-ROM and a comprehensive facilitators’ handbook

to evaluate the training package with health care professionals actively engaged in trial recruitment

if successful to train facilitators to disseminate the package as widely as possible

Module 4 Patients with a preference for one treatment

Professor Pierre Guillou with

Margaret, a demanding patient

discussing CLASSIC where one

treatment arm is NOT available

off trial

Peter, an ‘internet guru’ patient

listens to Dr David Bloomfield

discussing PRO7 where

treatment IS available off trial

Dr. Michael F. Bone

When things go wrong

Cytokine storm

Impaired consent

– Lack of information

– Lack of time

– Length consent form

Capacity and Consent?

Dr. Michael F. Bone

Ethics

Strategy

– Not good enough

Clinicians experienced in assessing

capacity

– Must be specific

In Europe, no gold standard for decision – making capacity assessment

In France, clinician’s judgment based on clinical datas Neuropsychological battery and (correlated to MMSE : Mini-Mental State Examination + ADL +behaviour assessment)

As a Global cognitive assessment does not correlate with the decision-making capacity

State of current tools for decision-making capacity

MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR)

• Positive Points:

Includes the four components of decision-making process

Numerous lines of evidence supporting its reliability and validity in english and French- canadian

Most widely used

• Limits:

Administration time of 15-45 min

Required training for a valid administration and interpretation

Dr. Michael F. Bone

In UK: Mental Capacity Act

2005

Research specifically addressed

Role of Consultee

Newcastle 85+ tool

San Diego for Europe?

UBACC: University of San Diego Brief

Assessment of Capacity to Consent

• Recently described (2008)

• Rapid test (< 5 minutes)

• 10 items scale

• Helps for screening large number of patients

• Basic documentation of decisional capacity

• As reliable and valid as the Mac CAT-CR test

UBACC: 10 questions

UBACC: 10 questions

Dr. Michael F. Bone

Further progress

Translated into German, Polish,

Hungarian, Spanish and Italian

? Validation

? EFGCP