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Medical trials in the spotlight -

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TRACY BOWDEN, PRESENTER: Four years ago, a clinical trial in the UK went horribly wrong, causing
systemic organ failure in its participants, a stark reminder of the dangers of drug development.

Fortunately, such bad outcomes are very rare, especially in Australia. In part that's due to the
use of ethics committees which have overseen trials for the past 30 years. But now those committees
are in the spotlight. Fears have been growing in the medical research community that Australia is
falling behind in the lucrative trials industry because of its relatively poor patient recruitment
and slow ethical approvals by overworked volunteer committees. Mary Gearin reports.

MARY GEARIN, REPORTER: A decade ago, Paul Bond couldn't have even imagined walking down the street
in shorts. Severe psoriasis that had started when he was a teenager had spread, worsened and no
treatments at the time helped.

PAUL BOND: It lowers your self esteem, it lowers your confidence, it stops you from doing things
like swimming. I was very introverted as a result of it. It sort of kept me in my shell. It's had a
massive impact on my life, basically.

MARY GEARIN: Finally, his doctor suggested he join a clinical trial for a new class of drug, and
within weeks the condition and his outlook turned around.

PAUL BOND: It was like being really, really overweight and then someone giving you medical that
within a couple of months you were back to normal. It was profound, the effect that it had on me.

MARY GEARIN: While Paul Bond was more than willing to become a guinea pig, it's either fear or
ignorance that's holding most other Australians back.

By international standards, Australia has poor recruitment for clinical trials, despite their
overwhelmingly safe history in this country. The main problem is that patients aren't usually told
about them. Although there are some websites like this one set up by two clinical trial nurses in
Melbourne, there's no one national portal for patients to find all the trials that could help them.

CHRISTINE VELJANOSKI, CLINICAL TRIAL CONNECT: Unless researchers are actually advertising or using
other forms of communication to reach out to members of the public and let them know that these
opportunities exist, it's very difficult for people to find ways to become involved.

MARY GEARIN: But it's feared desperate patients may find even fewer trials on offer unless
Australia's cumbersome ethical approval process has radical surgery of its own to compete with more
efficient nations.

JOHN FUNDER, PRINCE HENRY'S INSTITUTE: I don't think we should cut any corners, but I think that
the ethics is by and large very straightforward in 98 per cent of cases.

MARY GEARIN: Professor John Funder is Senior Fellow at Melbourne's Prince Henry's Institute of
Medical Research and is chairing the Government's reference group looking to overhaul how clinical
trials are approved. At the moment, he says, the process is a mess.

JOHN FUNDER: Ethics committee meetings in the most active institutions are 11 a year. The meantime
in one very good - medium time, in one very good institution, widely regarded as having an
excellent system, is 4.6 months between lodging it and approval. It's a glacial pace for something
that is in ethics terms, really, pretty simple.

MARY GEARIN: Father Bill Uren is one of the architects of the national statement on the ethical
conduct of human research and has sat on a dozen ethics committees over the past two decades.

BILL UREN, ETHICS COMMITTEE MEMBER: I think at times some committees have been too protective. The
spectre of a big pharmaceutical company sort of looms over the whole process and I think people
feel, "Well, we've gotta protect poor innocent civilians from these sort of unethical trials."

MARY GEARIN: What makes it worse, Professor Funder says, is that the delays can be for trifling

JOHN FUNDER: It sounds ludicrous, but one example offered to me was that a logo was missing on page
17 of the application.

MARY GEARIN: A long-time ethics committee chairman, Professor Stephen Leeder, is director of the
University of Sydney's Menzies Centre for Health Policy and he says the delays have been

STEPHEN LEEDER, PUBLIC HEALTH, UNI. OF SYDNEY: Maybe six weeks, four weeks, sometimes eight weeks,
but generally speaking we're not - the idea that this takes five or six months is really

MARY GEARIN: A clinical trial's action group is yet to report to government, but some of the
suggestions to overhaul the system have been dramatic. One is to make what have been voluntary
committees into well-paid professionals.

JOHN FUNDER: This is not to be done by volunteers. You need professionals doing this and doing it
as a job.

MARY GEARIN: How professional should they be? Is this a nominal payment you're talking about?

JOHN FUNDER: No! I'm talking about like we pay judges.

BILL UREN: There's something to be said for the altruism of the people who do this sort of review
and their impartiality. I just think when people are getting paid to do these things they're liable
to be biased - possibly liable to be biased.

MARY GEARIN: Another major change could be removing the requirement to include either a member of
the clergy or Aboriginal elder or pastoral carer on the committees.

SEAN SLAVIN, NAT. ASSN PEOPLE LIVING WITH HIV/AIDS: We simply think this is redundant. In this day
and age, we don't think that being a minister of religion gives you any special capacity to make
decisions about scientific research and their ethics.

MARY GEARIN: Professor Peter Foley is one of many researchers who've had to make changes for
religious reasons.

PETER FOLEY, UNI OF MELBOURNE: At some centres we can recommend that females at child-bearing age
not fall pregnant during the course of the trial, but we cannot advocate contraception. Letting
religious beliefs interfere with the way the wording of a consent form is perhaps unnecessarily

BILL UREN: A lot of research is conducted on - particularly medical research, on people who are
vulnerable. It's about people who are suffering from disease or disability. And so somebody who has
a pastoral relationship with people in that particular cohort is the sort of person we thought
brings a new perspective onto the ethical review. But it's not just a matter of what's up here in
the head, but what's up here in the heart.

MARY GEARIN: Perhaps the most fundamental problem has been that each and every institution involved
in a big trial has wanted to run it past its own ethics committee, causing massive delays. The
report is expected to recommend that in such cases, one leading institution could give ethics
approval on behalf of the others. This streamlining might even eventually lead to fewer, more
centralised, committees.

STEPHEN LEEDER: I think it would be very hard for a central agency to pick up those local nuances.

JOHN FUNDER: Many hospitals outsource almost everything - you know, catering, HR, whatever.
Outsourcing ethics is not a big deal.

MARY GEARIN: And waiting for the outcome of this ethical debate are countless Australians who may
one day be desperate to be guinea pigs.

PAUL BOND: If you're as lucky as me you might have some amazing results and give you back your

TRACY BOWDEN: Mary Gearin with that report.