Why we need more inclusion of older generations in clinical trials


As you get older you may notice that your body doesn’t always work as well with physical activities compared to when you were younger.

Some things are just part of the ageing process, including being more susceptible to illnesses, like colds and flu. This is why you’ll find that over 65 year olds are one of the groups at the top of the list for the Covid-19 vaccine roll out in New Zealand.

We are currently researching vaccines specific to older people and it’s great that we have a large research family of over 60 year olds to connect with for research opportunities.

As medical researchers, we understand the importance of finding ways to treat illnesses that are specific to ageing populations, especially as this hasn’t always been a priority in the field.

Underrepresentation of the elderly in clinical trials

You may assume research on treatments for older people, or trials involving older people, is commonplace, however they are still underrepresented in clinical trials.

Neuroscience technology company Cambridge Cognition explains that in the UK on average, older adults have a disproportionately higher amount of chronic diseases and use of pharmaceutical drugs, but only represent about one third of participants in Phase II and III clinical trials. 1

There are a number of reasons why this is:

Exclusion criteria

As mentioned above, for elderly people there is a likelihood that they are being treated for multiple medical complaints which can exclude them from being able to participate in some clinical trials. Taking additional medicines on top of the trial treatment can mask the results of the trial treatment, which is problematic in getting accurate results. 2

For this reason certain exclusions do have to apply across all age groups but this can also inhibit getting a larger representation of older people in trials.

Less motivation to participate

Some older people can have doubts about the usefulness of their participation in a trial or of the studies in relation to older people. 2

They also may be worried about logistics of how they will get to the clinical appointments on a regular basis if they don’t drive or are particularly frail.

Physical and mental demand

If an older person is quite frail they may find a particular trial quite demanding and this may put them off participating in other trials. 2

Why we need older people to participate in clinical trials

It’s vital we have more inclusion of older people in clinical research because people are generally living much longer than previous generations.

According to the World Health Organisation the world population aged 60 years and over will reach a total of 2 billion by 2050, up from 900 million in 2015. 3

This means there will be a greater need in the future for various treatments specific to older age groups.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) established a guideline in 1993 to support the inclusion of the elderly in trials. It states: “Drugs should be studied in all age groups, including the elderly, for which they will have significant utility. Patients entering clinical trials should be reasonably representative of the population that will be later treated by the drug.”

This has since been adopted by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and pharmaceutical companies worldwide. 2

Even with this guideline there is still the need for more inclusion, so we encourage those who are passionate about improving the quality of life for people through medical research - to volunteer for a future trial.

How Optimal makes it easy for our older participants

As we mentioned above, some elderly people can be put off volunteering for clinical research because of logistics. We strive to make all our participants feel welcome and supported through the research process, that’s why we offer the following:

  • Parking
  • Reimbursements for travel expenses and arrangement of taxis for pick up and drop off
  • Wheelchair/lift access
  • A warm, friendly, experienced team, many of whom are GPs, and older adult medicine specialists (geriatricians)
  • Light snacks, tea and coffee
  • Comfortable waiting areas in our reception and outside our clinic rooms

If you are interested in signing up for future trials or know someone who may be interested, applications can be made here

We look forward to offering more trials for older people in our community in the future.