UK Standard CRO contract

Australia's not the only country trying to tackle the enormous inefficiencies created by trying to agree clinical trial contract between sponsors and individual institutions. But the UK is just one short step ahead of us, having released this week their standard CRO contract. http://www.medicalnewstoday.com/articles/86856.php



With any luck, Australia will manage to tie up our single CRO contract in the next few months. We then just need institutions to accept the standard contracts on a sponsor specific basis, and we should have put an end to the months delays seen at some hospitals and institutions trying to agree these contracts.



I will be interested to hear Nov21 at the ARCS meeting an update on the progress of acceptability of the standard sponsor contract that has been implemented in Australia's Eastern-board states and whether it is achieving the time gains everyone hoped it would.

Refining a chinese herb for breast cancer trial

Here is an interesting article from TIME magazine just released on the challenge of converting chinese medicine into a product to be trialled...
http://time.com/time/health/article/0,8599,1671684,00.html?imw=Y
Time and patience...

A long lost friend and challenges in CAM research

A long lost friend was in touch over the weekend to chat with me about my comments on research in CAM - complementary and alternative medicine. I met this friend, who I'll refer to as SA, while we were both progressing through the challenges of doing a PhD, although she was close to finishing as I was embarking on my journey. I always really enjoyed our conversations, as she was far more broadly read than myself, and always had interesting perspectives to share... an old soul perhaps. As she was finishing her traditional scientific pursuits, SA became interestes in Reiki and CAM. At the time, I listened, but couldn't really understand, and remained a sceptic. SA moved away pursuing her CAM career, and my traditional science career continued.

Four to five years later, I was needing some stress relief in my life, and Reiki again crossed my path. This time, I was more open to the idea as I guess the idea had had time to ferment since SA first introduced me to it. I did the starter course, finding Reiki a useful technique to relax myself somewhat. While still somewhat sceptical, it seemed to work so what harm in using it on myself, even if not necessarily competent (or more likely patient enough) to do it on others.

Some time has passed since then, and it was a welcome surprise to hear again from my old friend and have her share some of her challenges in combining good science with CAM, given the hurdles of acceptability of CAM in the country she now resides in.

So to set the record somewhat straight, there are some places trying to conduct research in CAM, which I was unaware of, due to my surroundings in a conventional medicine environment perhaps, although there remains some challenges in the area. For those interested, here are a few links to interesting CAM websites, both in Aus and overseas, to help balance the debate:

http://nccam.nih.gov/clinicaltrials/ - US National Centre for CAM
http://www.asmi.com.au/Complementary%20Medicine.htm - Australian Self Medication Industry - Complementary Medicine
http://www.uq.edu.au/accmer/ - the Australian Centre for Complementary Medicine Education & Research, a joint venture between the University of Queensland (UQ) and Southern Cross University (SCU).
http://health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2005-cp-pyn010.htm?OpenDocument&yr=2005&mth=3 - Australian Government supports reform for complementary medicine

China's 287 trials beats India's 270 trials, if clinicaltrials.gov is any indication

While my previous discussion of India remains true, it seems perhaps China is ahead of India in its efforts to attract clinical research investment.
http://www.pharmatimes.com/ClinicalNews/ViewArticle.aspx?id=11947
It will be interesting to see who wins the race, and how other countries manage to retain their share of the clinical research pie.

Evidence based medicine - how does alternative medicine contribute?

A couple of weeks ago I met a gentleman at a training event I attended and we got to talking about the businesses we were each in. This gentleman was a naturopath and became quite animated when I discussed my interest in clinical research. As can often be the case when you mention a background of working in the drug industry, I quickly found myself trying to defend the industry I've been a part of. This gentleman was very anti-drug/company, with lots of conspiracy theories about why drug companies do what they do, and how messed up the health system is.

For me personally, I fell into the industry as part of my journey as a scientist. All I wanted to do as a scientist was research that would help people, and clinical research seemed one pathway I could follow to do that. Many of the colleagues I meet in the industry have the same vision. However, it seems that because we work for commercial organisations that make money, our intentions are to be questioned.

One of the arguments presented to me was that drug companies do unnecessary clinical trials that cost lots of money, and then use those costs to justify the price we need to pay for medications. From the naturopath's perspective, these trials are unnecessary, as are the drugs, as he claims to be able to heal many people for whom conventional medicine has not worked.

I have no reason to doubt the naturopath's claimed success rate, but also don't have enough evidence to believe him. As a scientist, you will often come up with ideas about how good something is or how it works, only to find when you test those ideas, they don't always stand up to formal review. This can be a heartbreaking moment, but at least the due diligence has been done and the evidence speaks for itself.

I don't think there is anyone in the health profession that would NOT embrace alternative medicine if there was adequate proof that the alternatives worked. Granted, there is alot of anecdotal evidence that some alternatives do work very well for some people. However, as a scientist, I am always looking for evidence. In fact, our conventional health system is increasingly based on the premise of evidence-based medicine. Without evidence, how can a government hope to be selective about the treatments the limited health budget is able to afford? Equally, how can doctors make decisions on the best treatment if there are not comparative studies to help them draw conclusions.

I challenged the naturopath to perform studies to help build the knowledge based around his treatments of choice, so as to improve their reputation and build the body of evidence around alternative therapies. However, he was not personally willing to put his treatments to the test through formalised research - especially since he knows it works. After all, trials are expensive and time consuming, and there is so much paperwork. He'd prefer to leave that to others to do. From an article I recently came across, it would appear however there isn't necessarily much good quality research going on to help his cause... (A systematic review of randomised clinical trials of individualised herbal medicine in any indication http://www.docuticker.com/?p=16983).

If then, drug companies choose to spend their money on trials in order to provide evidence to help prove either way the safety, tolerability and ability of their drugs to work, and then to share that information with doctors proactively, is it any surprise that this then forms the foundations of the health system that doctors dish out and governments help fund?

And it is not only drug companies doing clinical research, so money, while less readily available, can be sought from other more independent sources. Governments, consumer organisations, charities, philanthropic organisations, all fund medical research, including that on humans. To attract the funding, researchers increasingly need to collaborate, produce good scientific questions, and quality output, making it in theory just as within the reach of alternate medicine practicitioners as those in conventional medical research to attract funds to conduct that research.

One argument I've heard for not conducting research in alternative medicine is the individual nature many of those treatments take on, such that it would be hard to compare groups of individuals such as happens in randomised clinical trials. My counter to that however is that is can be just as difficult for drug companies to test their drugs in large populations of people. I think it would be recognised, particularly as scientists understand our genes and diseases better, no two individuals are perfectly alike, nor are the effects they will have from a drug alike. People experience different side effects, they have different success rates with different drugs. It may take doctors some time to define the right dose, or right drug, if it exists for a particular individual for a particular condition. The journey with alternative medicine can be just as much trial and error.

Yes, alternative medicine can work for some people, but it does fail others. I've had personal experience of such a failed journey with someone close. Whether alternative medicine techniques are any more successful on a population basis than conventional medicine, I don't know. I don't believe that conventional medicine has all the answers for everyone, just as alternative medicine does not, so an integrated approach is of value.

I say provide the evidence through formalised clinical research, and whatever the treatment, whether conventional or alternative, and it will lead to health practitioners being more comfortable to offer it as a treatment option for their patients.

Industry sponsorship of trials

It's nice for a change to see a balanced discussion of industry-sponsored clinical trials... http://reason.com/news/show/122020.html.
This article deliberates the pros and cons of industry sponsored research and the debate around conflict of interest vs . Coming from an industry background, it's nice not to be completely beat up for doing a job you hope will help people feel better in the future by helping bring new medicines to the market.

I've attended a few industry meetings of late where there have been a greater proportion sitting on the researcher side of the fence than the industry and I have come away feeling disappointed with the level of respect for the contribution of industry to research. Industry is always the bad guy - work with them so you get money to do the REAL research you want to do. After all, industry is only interested in making profits, so have plenty of cash to throw around, right?

I don't mind saying I get a little worn out by this attitude. Can you really tell me that doctors do what they do just for the love of it? Of course not... they too expect to be paid, as does anyone who works for a living, especially when they have spent so long developing their expertise in an area. Industry is no different in this respect, and they too need to appropriately manage their resources to ensure they are able to continue to deliver new treatments, continue to employ the thousands they employ and deliver a return to their shareholders.

Yes, industry makes profit. But who are they making the profit for?... the shareholders. Why do it for the shareholders? So they can continue to fund the development of more products. Only 1 in 10,000 compounds identified will ever make it to the clinic and it costs upwords of a billion dollars today, taking into account the discovery, development, manufacture, approval, distribution and marketing to bring that new drug to market. That's quite a burn rate. We've all seen when companies development pipelines are not strong what this does to the value of companies (their share price), or for those companies starting out, the impact had when a product in development does not meet expectations and has to be canned. This can end a new company. That's alot of pressure on anyone, and one might suggest this is reason to doubt the intentions and trial results delivered by industry. However, you can't tell me that in today's litigious environment companies are all about making drugs that are knowingly going to do bad things to people's health on purpose! Where is the sense in that argument?

Things do go wrong sometimes, as we've seen with a few drugs over the past few years. Partly this is because it just took thousands and millions of people to take the drugs in the 'real world' outside controlled clinical trial conditions and patient groups to see the effects sufficiently, over a longer period of time than is possible in the drug development process with a few thousand patients over 8-10 years. Industry, researchers and regulators are continually learning from these events, and try to ensure appropriate oversight to reduce the risk of such events in the future. Maybe I'm naive, but I can't think that industry would send these drugs out onto the market knowing the benefits wouldn't outway the risks.

Anyway, back to the original subject... It would seem researchers are happy to put their hand out for industry sponsorship of studies, but don't readily publicly acknowledge very often the role industry plays in helping them progress their own research objectives. Yes, industry compensates for the time and resources needed to conduct a study, and they try to be fair about this, although this is an ongoing process of negotiation. But industry also know that this compensation helps fund a considerable amount of non-industry research, which can apparently be performed at a fraction of the cost of industry sponsored research.

I had a bit of a debate with someone at the ICTS in Sydney this week over just this. They told me industry should pay them more money for the work they do, because their research unit struggles to survive. I then asked whether the reason they couldn't survive is because the balance of investigator initiated studies to sponsor studies was out of kilter? That did cause a moment's pause, but it didn't last very long, and it was back to industry should pay us more. Oh well...

The article above suggested "Collaboration between academia and industry should be encouraged, not attacked. " I heard the same catch-cry at the ICTS on Monday. However I think before we will ever get the public and media to take on a more balanced view of industry sponsored research, we need the researchers to publicly acknowledge industry is less 'the devil' and more 'equal partners' in the advancement of medical knowledge and treatment.

Pig cells in Humans

Just because we can, should we?

This is an interesting news article published today on a trial using pig cells to produce insulin in humans. http://www.themoscowtimes.com:80/stories/2007/09/20/017.html

I imagine that the ethics committee in Russia must have had plenty to discuss when this proposal came across their desks, assuming the study underwent the same rigorous review procedure we would expect under international Good Clinical Practice guidelines. If it works, the potential benefit to diabetic patients would be enormous. However, I'm not sure how comfortable I am personally with living animal cells being transplanted into humans. I suppose in theory it is no different to taking in probiotic bacteria to boost our gut flora, another living non-human organism inside us.

I wish Living Cell the best of luck in developing this technology, and ensuring the research undergoes rigorous ethical and scientific review and debate throughout the entire clinical development process. It's never easy pushing the boundaries of medicine and public opinion.

ABC New Inventors Program 19sep07 - EzyVein by Dr Dane Horsfall

Did anyone happen to see the ABC (Australia) New Inventors Program last night?

There was quite a neat little device, the EzyVein, invented by Dr Dane Horsfall, for improving the success of cannulising veins in difficult patients. Here's a link for anyone interested... http://www.abc.net.au/tv/newinventors/txt/s2034774.htm

I was pleased to see the panel refer to the process of clinical trialling for establishing appropriate design, efficacy and safety of the device. Discussions like this in open forums help remind the public that there is a process by which new medical devices and treatments come to the market, which involve testing on humans, ie clinical research. That process involves designing research studies with scientific merit, review of those studies by human research ethics committees before they are started (if there is deemed to be anything more than low risk involved in the project), then appropriate conduct, analysis and publication of the research.

We wouldn't have progress in medicine without a process for scientific discovery and translation of those ideas into clinical practice. Understanding that process is important for ensuring continued participation in research at all levels, whether as a research, research participant, or sponsor of research, or as final end user of the outcome of the research. After all, would the EzyVein have become anything more than an idea in Dr Horsfall's head if there wasn't someone willing to let him test the idea on them?

An example of the need for clinical research

I came across an interesting blog today (http://blog.parentprojectmd.org/archives/2007/09/eye_exams_and_c.html) by someone affected by DMD (Duchene Muscular Dystrophy). To summarise, it reflected on the process of an eye exam and the desire that going to a doctor to find the right treatment for a medical condition was as easy. It made a couple of interesting points:

"Clinical trials are not synonymous with treatment; rather clinical trials provide the vehicle for us to understand IF a certain strategy provides benefit and characterize exactly what ‘benefit’ means. "

I agree with the latter statement in that clinical trials help us understand the efficacy, safety and potential benefits against risk of a particular treatment. I think perhaps the first half of the statement is a little limiting however. There is not a treatment that is approved that has not undergone clinical trialling, so by default, clinical trials are synonomous with treatment. What we perhaps need to be reminded of is that not every treatment assessed by clinical trials will result in an approved treatment. This can be for many reasons. But it is important that this research is conducted in order to establish what works and what doesn't, and for that to happen, there needs to be willing participants.

I think the blogger summed up the problem very nicely with this: "I wish it was as simple as an eye exam – invest money in a strategy and you get an answer. The real fact is that the only way to accelerate the development of treatments is to invest in a comprehensive plan to accelerate research, develop a system to identify patients, collect specific data, organize clinical trials in the context of an international clinical trial network and pursue an aggressive legislative agenda to insure successful treatments can be delivered to all individuals and accessed over a lifetime."


Hear, hear!

Joining the 21st Century Community of Bloggers

I've done it... I've created a blog.


For someone who is not technologically savvy, this has been a big hurdle for me to overcome. I'm a generation X-er, so not that old, but all the new ways to communicate and connect are proving a challenge to get my head around. Thank goodness for Small Business September, and a great seminar I attended yesterday with Laurel Papworth and the Women in Business Network, for getting me over the nerves of trying this. It took 3 different seminars for me to feel comfortable enough to try, but here I am.


So where to now? I'm passionate about clinical research. As a trained scientist who has worked in academia, biotech, pharma and CRO-land, I've had a great learning journey about medical and clinical research, it's challenges and joys.


Not everyone knows the ins-and-outs of clinical research, how it is done and how that research is translated into the treatments that we all expect each time we go to the doctor. I hope that sharing just a little of that knowledge will encourage people to get involved and contribute to clinical research in whatever way they are able, as sponsors, participants, reviewers, researchers, professionals, etc. That way we can all be sure of ongoing medical discoveries being translated into positive benefits for our health for the future.

What's your clinical research story?