Clinical trials: risk or reward?

Clinical trials with hefty volunteer compensation sounds like something out of the 60s but it is happening every day in New Zealand.

There are as many as 20 clinical trial units in New Zealand that carry out hundreds of trials a year.

Of course, they need volunteers to participate in trials who receive compensation (they aren't allowed to call it payment) for their expenses, time, trouble and the possible risks.

Chemical engineering student, Mark (not his real name), is about to start a 22-day trial of Hepatitis C medications.

Mark says he was drawn to the trial's compensation of $7500 before tax.

This is the first time Mark will take part in a trial where he is "compensated" for his "time".

To earn the $7500 he will be staying at Auckland's Clinical Studies unit for three weeks, undergoing testing and monitoring.

The possible known side effect of the medication is headaches.

There is also a 33 per cent chance he will receive a placebo sugar pill.

"But if you are shoving something quite dangerous down someone's throat and something might happen then they ought to be compensated," Mark said.

The 24-year-old says he thinks the compensation outweighs the risks and inconvenience.

"If you work out the hourly rate it's pretty worthwhile."

Mark says while he's interested in the trials, which are needed for new drugs to come to market, it is more about the money.

A mixture of people seem to participate in clinical trials, he says.

The ill and desperate looking for a cure, the old and lonely looking for comfort and the young and poor looking for money.

Mark's first experience with medical research studies came after he was made redundant from his fulltimejob last year.

While waiting for Work and Income to process his dole application Mark signed up for as many volunteer jobs as he could find and ended up participating in medical research studies for masters and PhD students.

He was reimbursed for his expenses but the payment was nothing like the big bucks he's looking at for the Hepatitis C trial, codenamed Ninja and sponsored by US company Achillion Pharmaceuticals.

Achillion pays privately-owned Auckland Clinical Studies to carry out the trial.

Auckland Clinical Studies was established in 2006. Its sister company Christchurch Clinical Studies, which was started in 1999, carries out similar trials.

Mark says if this trial goes well he hopes to participate in one for an anti-inflammatory drug.

For this trial he would receive $3000 before tax for short morning visits and tests for 11 weeks.

The Auckland student found out about the trials through job site Student Job Search.

Clinics have trouble finding or retaining healthy trial volunteers so it makes sense to advertise on the job site, he says.

It is not a "predatory" move to lure students in desperate need of money, he says.

"If you don't have healthy participants then drugs don't make it on to the market."

Mark is not part of a select minority in New Zealand.

According to the Australia New Zealand Clinical Trial Registry (ANZCTR) database there are currently 1267 clinical trials registered on the ANZCTR that are recruiting or have recruited participants in New Zealand.

There were 216 clinical trials registered on the ANZCTR that started or planned to start recruiting participants in New Zealand in 2013 and there are 40 clinical trials registered on the ANZCTR that start or plan to start recruiting participants this year.

New Zealand Union for Students' Association president Daniel Haines says clinical trials with compensation are attractive to students who need to earn money while studying.

"You can't study if your table and pockets are empty."

People who participate in clinical trials think the money is worth the possible risks, side effects or inconvenience, he says.

Haines says he doesn't have any issue with the trials themselves.

"I absolutely think what they are doing is fantastic.

"I just wish students weren't in such a desperate situation."

Unfortunately, money comes first, Haines says.

Allowances and living costs are cut off during the holidays and students need to find a way to earn, so clinical trials are an option for them.

The compensation from some trials is greater than a full-time wage, he says.

Haines says he has never heard of a student participating in a clinical trial for the experience or to help advance medical research.

It's always for the money.

However, there are some kiwis who participate in clinical trials for the love rather than the money.

Ruth Fine has emphysema, a hangover from her smoking days.

The 73-year-old Wainuiomata woman has been taking part in trials relating to her lung disease for the past eight years.

At the moment she is volunteering in a clinical trial for P3 Research in Wellington.

The P3 clinical trial unit was formed in 2001, with a second clinic opened in Tauranga in 2005.

The Wellington unit is involved in 25 clinical trials at the moment, with about 20 trials taking place in Tauranga.

P3 says volunteers' costs are covered and they are sometimes compensated for their time.

Fine has been volunteering on the trial since September and spends full days in the clinic about once a month.

She will be compensated $1200 for her time.

But Fine isn't doing it for the money.

She has a daughter and granddaughter who smoke.

"I just think that doing these studies one day might help them."

Fine says taking part in the trials is definitely worth the inconvenience but it is not easy.

"It's silly saying it's hard but because I've got emphysema it's hard."

Fine says for healthy people the blood tests, travel and staying off medication before and during testing is easy.

But someone needs to pave the way.

"If you don't have guinea pigs you don't learn anything."

The Health Research Council is New Zealand's regulatory body, which manages government funding for medical research and ensures trials are necessary, safe and ethical.

Health Research Council chief executive Dr Robin Olds says it's usual for there to be some compensation from clinical trials for out-of-pocket expenses.

Compensation is sometimes granted as recognition of time but the ethics committee ensures companies are not "recruiting" volunteers for a sum of money, Olds says.

"Yes there is usually some compensation but there's great care taken so it can't be seen as inducement."

If the compensation offered for a trial "smacked of any inducement" the committee would not approve the study, he says.

The ethics committee assesses the risk-benefit ratio of the trial is appropriate.

The committee also decides whether the trial method is appropriate, if it's being carried out by the right people in the right place, how participants are recruited and whether they have all the necessary information about the trial.

Olds says the regulatory environment is favourable for clinical studies as it was faster than other countries.

This is only one of the reasons New Zealand is a bit of a hot spot for clinical trials.

Big pharmaceutical companies looking to conduct a trial are seeking a high-quality health care system, a place with available volunteers, a good regulatory environment and well-trained doctors, Olds says.

New Zealand ticks all the boxes.

"But New Zealanders in general are quite altruistic and they want to engage in health research and medical research."

While there is not a lot in it for clinical trial volunteers they want to participate in something that can benefit the community, he says.

However, students or those strapped for cash would disagree with Olds.

There is a lot in it for them: The possibility of raking in thousands of dollars in exchange for being prodded with needles and subjected to a specific diet.

But those considering trials as a way to get rich quick should be careful to always read the fine print.

Olds says a serious adverse event such as a death is "very very rare".

Extensive laboratory and animal testing is carried out before the human testing phase.

In the first phase drugs or procedures are usually tested on small groups of young, healthy people.

If the test results are positive phase two and three human trials are carried out on larger groups.

But even the most stringent safety procedures don't extinguish the risks.

"Any intervention, any drug and procedure always have some risks associated with it."

In 2006 Christchurch man David Oakley took part in a clinical trial at London's Northwick Park Hospital.

Oakley became known as the "Elephant Man" he and five other men had a violent reaction to the drugs.

The now-father had volunteered for the trial to help pay for his wedding and mortgage but was instead left battling for his life.

He remains at high risk of developing cancer and his short-term memory has been destroyed.

In 2008 the only compensation the six men had received was a [POUND] 10,000 ($20,000) interim payment from the German drug manufacturer TeGenero, which has since gone into liquidation.

Parexel, the American company trialing the drug refused to admit liability.

Fairfax Media