Older people excluded and under-represented in clinical trials

“The pharmacoparadox is that the most important healthcare intervention [medication] in older people is inadequately tested in this group,” stated Carmel Hughes, professor of primary care and pharmacy and director of research, University of Belfast, during a session at the RPS conference.

She explains that the evidence for this paradox come from the EU funded project entitled “Increasing the participation of the elderly in clinical trials” (PREDICT). It investigates reasons for the exclusion of older people in clinical trials and provides solutions. The PREDICT project covers many countries including UK, Italy and Spain.  

Professor Hughes said that in a systematic review that older people were being excluded and under-represented in clinical trials because of co-morbidities, concurrent medication, frailty, advanced age and ethical concerns. Using a heart failure systematic review published this year as an example, she explains that it is difficult to extrapolate data from trials using younger people for use in the older population.  

“Doctors, pharmacists and other healthcare professionals are not in a position to be able to make confident decisions about whether or not to start a particular medication in an older person when there is not the trial data to support it,” states Professor Hughes. She gave possible solutions, such as limiting exclusion criteria in trials, providing transport to sites and offering follow up at home.

When addressing the uncertainty of medication effects in the older population, she gave various suggestions made in a study, including balancing efficacy and effectiveness, monitoring adverse effects and close monitoring of older people in protocol.

The opposing end of the spectrum, children, were also considered in the same session by Claire Norton, senior clinical trials pharmacist, Birmingham Children’s Hospital.

Toxicity, lack of studies and variability in children means that drugs are not recommended for use in children, and often drugs are used unlicensed or off-label, explains Ms Norton. “Children were excluded from the drug development process and, as a result, we have exposed children to unwanted side effects, incorrect dosing and uncertain efficacy,” commented Ms Norton.

She explained that the barriers to paediatric clinical trials included financial barriers, children are a small market and there is an increased risk of harm. Logistical barriers include the variability in children, hospital visits, choice of formulation and difficult dosing. Lastly, ethical barriers include vulnerability of children, their easily distressed nature and lack of understanding.

Ms Norton spoke about EU incentives for paediatric research, the latest being the paediatric-use marketing authorisation. The first one was granted in June 2011 concerning Buccolam in severe seizures (PJ, 6 August 2011, p161). In addition, she spoke of the Medicines for Children Research Network in England, which supports paediatric research and promote quality research in various ways, such as providing research infrastructure, adopting suitable studies and monitoring recruitment.

Ms Norton concluded: “We are getting a long way towards licensed use in children. We are not there yet but we have made wonderful progress.”

 By Rakhee Mistry