A bit of a giggle remembering past PI's

The ScienceBlogs weekly roundup this week highlighted a funny blog with a cartoon and reflections of the 9 types of PIs (principal investigators, the head honcho's of research projects). http://scienceblogs.com/insolence/2007/10/what_kind_of_pi_am_i.php

For my first job post university in a medical research institute, I had a PI that was part slave driver, control freak, science wonk and rising start (or at least he thought so). Add 'Swiss' and their known penchant for precision to the mix, and you can probably understand my dilemma. Although I have to admit, attention to detail, if it wasn't before is now very much a part of my repetoire, probably making me at times a tough boss to please, and delegation a challenge! Worst 2 years of my career professionally, though the Friday night bonding pub sessions at the 'Marly' with fellow suffering teammates made for good times, and some of those friendships still survive 12 years post-PI #1. PI#1 had me searching for ways out of the lab (or at least His lab).

How bad must it have been when the option I chose next was to do a PhD. Nothing like working at least as hard, for less money, but at least the atmosphere was better. PI#2 was a mix of 'big talker' and 'laid-back'. I only ever saw him at times when I needed to apply for money or ethics review, had to present at the company who sponsored my research, or to get my PhD chapters reviewed, but because of the 'big talk', he knew how to spin to get things done, so probably a good mix on balance.

After psycho-boss PI#1, to go to the complete opposite was a bit scary and stressful (after all, how would I cope without PI#1 breathing down my neck, telling me what to do and think and criticising everything? Was I capable of thinking on my own? ). PI#1 refused to believe I was capable of doing a PhD, as he went to great lengths to tell me. I had asked to do a PhD under PI#1, but he turned me down. I guess I can be grateful to him for that at least, and sparing me another 3 years of pain under his supervision. (You can tell can't you - no scars here from the PI#1 experience, and we wonder why people don't do or leave science!) Thankfully, doing the PhD showed me I was capable of original thought and led me to believe I could have some value as a scientist. PI#2 offered me a job post PhD which set me on the path to industry and out of the lab, for which I am truly grateful, so he wasn't so bad.

I think we could translate some of these cartoons to the arena of clinical research PIs, of whom I think I've encountered every type over the past 8 years, but a few minor revisions would be necessary. For example the Big Talker Clinical PI - same text out of his mouth would be appropriate. The +ve = good for encouraging others to become involved with the trial, or later publicity of the new treatment. The -ve = overdelegates and never available to sign off a CRF or paperwork. If I had some cartooning skills, I might just have a go at the revisions, but alas, I'll spare the world from my attempts at drawing!

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.

Stories from China, India and Nigeria + reminder of ethics

How quickly time has passed since the last entry. I avoided the election debate between our two fearless political leaders last night in favour of catching up with a former colleague visiting from the UK for an investigator meeting. Mind you, I ended the evening sitting on my balcony debating the pros and cons of each political party with my husband anyway, so not a completely politics free night. I suspect with 5 weeks to go to the election, it won't be our last debate on the subject.

Thought I'd share a few of the interesting clinical research stories I've come across in the past few days.

1. Here are a couple of short articles from Nigeria, on a call for more clinical research, and education on clinical research in their country.
http://www.thetidenews.com/article.aspx?qrDate=10/19/2007&qrTitle=Akunyili%20calls%20for%20clinical%20research%20capacity&qrColumn=NEWS

http://www.thetidenews.com/article.aspx?qrDate=10/19/2007&qrTitle=Researchers%20need%20education%20on%20clinical%20trials%20—%20Ikeme&qrColumn=HEALTH

I think this is great to see, and certainly will help set the scene for Africa to be the next powerhouse in clinical trials, after the Asian revolution. Of course, there still exist alot more issues and barriers to research in Africa, to avoid occurences such as that for which Pfizer is currently defending (http://www.outsourcing-pharma.com/news/ng.asp?n=80208-pfizer-nigeria-trovan-clinical-trial), but hopefully time and education will see these ironed out.

2. http://www.channelnewsasia.com/stories/singaporelocalnews/view/306653/1/.html
Singapore wants to become the world's leading centre for neuroscience and their government are putting in place infrastructure to help facilitate that. Part of that infrastructure, includes the development of a national Academic Clinical Research Organisation (ACRO) to be set up by early next year to encourage more clinical trials to be conducted in Singapore.

I suppose this idea is something like the NHMRC Clinical Trials Centre in Australia.

3. http://www.interfax.cn/displayarticle.asp?aid=28794&slug=PHARMACEUTICAL-CRO
This article discusses China as a future CRO powerhouse, the pros and cons of that current environment, in light of heavy competition from India.

What I thought most interesting about that is the reference to the way the Indian government is supporting clinical research in India, which appears to be proving very successful for developing the country's CRO industry - the exemption of CROs from service tax obligations.

4. In light of all these news stories about research in developing countries, it was a timely reminder when I came across this blog today, which among other things has a library with a few articles on the ethics of research in developing countries: http://katescasebook.wordpress.com/reading/

Happy reading!

Science can be more than labcoats and glasses

This is an interesting story for those struggling to recruit clinical research staff, about staff shortages in the UK: http://www.pharmatimes.com/ClinicalNews/ViewArticle.aspx?id=11972

Anyone who has working in multiple countries will know this is a world-wide phenomena, and one that is likely to continue for some time, given the rapidly expanding clinical research environment, both in the traditional regions for research such as Europe, US, and might you say, Australia, but also for the newly establishing developing countries like India, China, Africa, to name a few.

What is the answer? One answer explored in this article is key I think - publicise the industry as a career choice. Most people I know fell into clinical research by accident, rather than design. Had I known about the clinical research career pathway earlier, then I probably wouldn't have spent years in a lab first. Mind you, if we convert everyone into being clinical researchers, then we won't people left pursuing basic and pre-clinical research, the foundations necessary before clinical research can be pursued, so there must be some balance.

We need to cast off the image of science as only people wearing labcoats and glasses, and make it as attractive and popular as being a sports hero, or movie star (well, we can dream anyway). Then we might have more people pursuing science, for the rewards it can bring both personally, and to the population as a whole. I think the popular science TV shows have gone some way to helping this, but we've still got some way to go yet.

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.

It all Action in India!

Over the last week, I have seen so many stories about big pharma operations in India. I can't help wondering if these are new news stories, or the Indian press is very good at highlighting the success India is having attracting and rapidly expanding a very active clinical research environment.

Wyeth, GSK Plc., AstraZeneca Plc., Pfizer Inc. and Sanofi Aventis, are just a few of the big pharma companies with their fingers in the Indian pie, according to reports just over the past 2 weeks. I'm sure it doesn't stop with those few companies. Additionally, the CRO market is also expanding at a rate of knots. One report suggest the Associated Chamber of Commerce and Industry of India (Assocham) projected the domestic Indian CRAMS (Contract research and manufacturing services) market will reach $ 900 million by 2010 and the demand in clinical research will grow from $200 million by end of 2007 to $ 1 billion by 2010 (http://www.expresspharmaonline.com/20071015/westbengalpharmareview01.shtml Pharma Industry in West Bengal: The Road Ahead). That kind of growth potential is enough to get any budding entrepreneur or company executive excited over the possibilities.

One has to ask - how does India plan to maintain control and quality with such rapid growth over so short a period of time. Just getting the trained staff (or training the staff) to meet that demand for services could only be described as an Everest climb at best. Initiatives like the recently announced launch of a new course by The Institute of Clinical Research (India), a global post-graduate diploma in clinical research in association with the Institute of Clinical Research, United Kingdom, will certainly help. But there is no better experience builder than time itself provides, in addition to formal training and mentoring.

If India knows the secret to managing this growth, then it's a secret we could do well to learn here if we are going to continue attracting clinical research to the Pacific and the opportunity that provides for Australia/NZ consumers to access the latest potential cutting edge treatments early.

It will be an interesting journey for all involved I suspect in developing a quality clinical research culture in all the developing nations, seen as the latest hope for controlling spiralling R&D costs through cheaper labour and expansive, relatively naive, population pools.

If these populations are not to be taken advantage of, it is important that consumers involved in the research are also well educated as to their rights, choices and the principles of informed consent. Big pharma and CRO's must take some responsibility in facilitating this education, if only to help develop trust and transparency in their intentions. Only educated consumers will make truly informed decisions about whether to participate in research, and not just participate because it offers a hope of treatment that they wouldn't otherwise have access to due to underfunded or non-existent health facilities. The challenge of educating consumers in a relatively well educated society such as Australia is difficult enough, without adding the challenges of language, education, poverty and access into the mix, as is the case in developing nations.