Some specialists worry drug trials are compromised when patients getting the placebos are swapped onto medication.
For many cancer patients, clinical trials are both a way to test out new treatments but possibly also their final hope for a recovery.
The scientific trials can put patients at risk of bad side-effects, while for others it can see them end up in the control group on a placebo rather than on the drug.
Australian patient advocate Jenny Wale said the impact on patients needed to be given more consideration.
“Clinical trials are generally designed so that the drug companies can get the drugs through the regulators within each country,” she said.
“They’re just looking at a clear demonstration of the effectiveness of the drug and … safety of the drug without a thought about the people who actually contribute to the clinical trial.”
International conference grapples with ethics
An international conference in Adelaide brought together doctors, pharmaceutical companies, regulators, buyers and patient advocates to consider some of the issues.
It discussed if and when patients should find out if they are in the control group and whether or not they should be able to swap groups.
Conference chairman Emeritus Professor Lloyd Sansom, from scientific and ethical review not-for-profit organisation Bellberry, said swapping from the control group onto the drug was becoming more common during trials.
“We need to be smarter in the way we do these trials because the very nature of the trials is changing and we’ve got to get in front of it,” he said.
“We’ve got to make sure that all the stakeholders come together with a common purpose … does the new therapy improve life for people and does it represent value for the total health system?”
He said it presented a challenge for checking scientific results.
“Because of the very nature of switching from one arm to another, the analysis becomes more complicated,” he said.
“Instead of saying ‘We can’t let it happen because it’s too hard’, [we] have been looking at what are the issues, how can we address them in a fair and equitable way for everyone?”
Experts share views and get new perspectives
Dr Chris Henshaw, a consultant for governments and companies on the development and introduction of health innovations, said the Adelaide conference presented an important opportunity to advance the issues.
“All of these people have got a very valid perspective,” he said. “They don’t always understand where the other person is coming from, so one of the values of these kinds of discussions is actually just getting on the table where everyone is coming from. Interestingly you frequently find more common ground than you’d expected.”
He said the health industry was accepting that crossover during drug trials was inevitable.
“There’s a range of views about when we should allow crossover and even whether we should allow it but it’s absolutely clear that patients are demanding it,” he said.
“Patients will either drop out of trials or refuse to join them if we don’t find a way of accommodating their wishes and interests.
“When we do agree that crossover is a sensible way to manage a trial, we need to think about the wider implications … for how we do other aspects of the trial.
“It may mean we need to collect more data to allow us then to try and figure out what was happening in that trial even though we have the crossover. It may mean we need to collect data in other studies to supplement the data we’re sort of ‘losing’ from the trial, so all of that needs to be thought through.”
A position statement will follow from the Adelaide meeting and be circulated throughout the industry.