LAY VERSION OF THE CHARTER

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PREAMBLE

Older people are the fastest growing section of the population in Europe and in developed countries. They should be included in research [clinical trials] which deals with their illnesses. Most long-term conditions, such as high blood pressure, become more common as we age. More medicines are prescribed for older people since they often have more than one thing wrong with them and each condition may need a separate drug.

Older people also have the highest risk of problems from their medicines. This is because they take a variety of medications. Although regulators now require that older people are included in clinical trials, this doesn’t often happen. This puts both prescribers and patients in a difficult position. Doctors may have to decide to prescribe a drug even though they might have limited knowledge of its effect and side effects in older people.

Older people receive treatment which has been shown to be effective and safe in
younger adults. However, this does not mean that this will work in the same way on an older person.

The PREDICT project examined why older people are kept out of clinical trials and how this situation might be improved. This research was funded by the EU and took place in the Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain and the United Kingdom.

PREDICT looked at scientific evidence as to how and why older people are excluded and how to correct this. Health professionals, and older adults and carers were also asked for their opinions.

PREDICT researchers found that older people are unjustifiably kept out of clinical trials. Even worse, this exclusion happens for conditions that are common in older age, such as, depression, dementia and heart disease.

PREDICT found that health professionals believe that this under-representation in research puts older people at a disadvantage. They also feel that this should be changed.

PREDICT found that patients, and their carers, believe that older people have the right to be invited to take part in clinical trials. They feel that they should have information from trials that will allow them and their doctors to make an informed decision about new drugs or new treatments including information on improvements in quality of life. This Charter was drafted with information from the above research. This process involved many scientists and other people in all nine countries of the PREDICT project.

For more information see the PREDICT web site:
www.predictEU.org

Charter for the Rights of Older People in Clinical Trials (lay version)

1.

Older people should expect to be offered drugs and other treatments that have been properly evaluated in clinical trials.
► These drugs and treatments should be shown to be effective in people of their age.

2.

The inclusion of older people in clinical trials should be promoted.
► For treatments that are intended for use in older people, older people should be informed about clinical trials and invited to take part.
► Older people should be included in clinical trials without discrimination on grounds of age, gender, ethnicity or social class; nor should they be automatically excluded because other illnesses, disability or existing drug treatment.
► People with several illnesses and those taking commonly prescribed medicines should be encouraged to take part in clinical trials.

3.

Clinical trials should be designed so that older people can participate easily.
► Information about clinical trials should be clear.
► The informed consent procedure should be adapted to any specific needs of older people. It should take into account their level of literacy and any difficulties that they may have with seeing or hearing. If needed their family or caregiver should be involved.
► There should be special training for those carrying out clinical trials in older people so that they can accommodate any special needs that they may have.
► It should be recognised that older people participating in clinical trials may need extra time and extra support.
► Special attention should be paid to those who have difficulties with mobility and communication.
► There should be support for older people in clinical trials who have responsibilities caring for others.

4.

Clinical trials in older people should be as safe as possible.
► Researchers should assess the benefits and risks for older people to take part in clinical trials.

5.

Outcome measures should be relevant for older people.
► Older people and carers should be included in the design of clinical trials and in the choice of outcome measures.
► Clinical trials for common conditions in older people should consider results that they themselves feel are relevant e.g. quality of life measurements.

6.

The values of older people participating in clinical trials should be respected.
► Each older person should be respected as an individual.
► Older people should be able to withdraw from clinical trials without losing any benefit of other treatments or their overall care.

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