Changes in the Industry over the last 25 years – from the perspective of a locally founded CRO
Helen Allars is ChairPerson/ Managing Director of Datapharm Australia Pty Ltd.
In 2012, year when we celebrated Datapharm’s 25th anniversary, I was asked how Datapharm started, as in 1987 the CRO industry was only just emerging and what change have we seen over that time.
How did you start in the pharmaceutical industry?
Having been cloistered in research laboratories during my MSc and PhD and teaching at UNSW, my first introduction to the ‘pharmaceutical industry’ was in 1984 as a ‘job-sharing’ CRA in a ‘big pharma’. At that time creating a flexible split-role for two women, both with two little children, was quite a modern and innovative step for our medical director and our story was written up in the local newspaper.
What was the role of a CRA back then?
The role of a CRA then was very different to that of today’s CRA. This was prior to the introduction of TGA’s ‘GCRP’ in 1989 and later ‘ICH GCP’ as we know it today. Sites participating in clinical trials sponsored by pharmaceutical companies were monitored infrequently (sometimes 2 to 4 times per year) where our most important role at a monitoring visit was to take the investigator out to lunch. CRFs were collected by photocopying the paper CRFs at the site and lugging them back in your hand luggage on the plane.
CRAs also had a responsibility for providing medical information. All letters responding to queries from sales reps were handwritten and typed by a secretary who had a very basic electric typewriter.
There was no internet or email or mobile phones – communications to head office were through a large machine called a Telefax where someone ’upstairs’ sent off our important hand written messages. Another part of the job was to check all advertising proofs before release to check that the wording of the claims could be justified – it was often a challenge to check the publications since we relied on an in-house librarian with a card index system.
How did pharma companies deal with clinical data back then?
There were no systems to collect data from CRFs, in fact our statistician used to hand write the data onto sheets in pencil and analyse the results using a calculator and write the report in pencil. It was in these prehistoric days, that I developed a passion for collecting clinical data, stats analysis and fascination with the emerging wonders of computers. I introduced the first computers into our department and joined the Lotus Users Group to network with others dabbling in programming spreadsheets.
How did you start to work from home?
When our third child was born in 1986, our medical director, still supporting flexible working arrangements for women in the industry, suggested that I may wish to work from home. With a new IBM XT PC with colour screen, 20 megabyte split hard drive, DOS, SPSS stats software and with spooled paper I was soon busy entering CRF data and programming in SPSS. I was so excited about statistics, I studied undergraduate Statistics at UTS that year. I had to use a lot of female multi-skilling to balance the demands of a new baby daughter, two active boys at school, studying and the challenges of a home-based office. It was not unusual for me to be running SPSS programs overnight and my husband, built an innovative sound hood for the clunky printer as it wailed away printing off tables at dinner time.
Do you feel there has been much change over the years?
Over 25 years we have seen immense change. We have gone from one computer to hundreds, moved from communications with a heat sensitive paper fax to keeping abreast of new technologies including systems that comply with 21CFR Part 11, EDC and ePRO and now social media.
How did Datapharm transform from a consultancy to a CRO?
In 1987, I continued from home as a consultant and Datapharm was officially born.
Other clients followed and I was so busy that I needed to have assistance. That was when we invited some ‘mums from the school’ to work on a casual basis with us. When they started they used to enjoy the flexible hours allowing them to drop and pickup up kids from school and some stayed with us for many years in their changed role as grandparents. We were able to provide a family friendly workplace for women with kids and this has been continued today – over the years many of our staff have had babies and stayed working with us.
Over the years we have been fortunate to have as part of our team, many young scientists, medicos, statisticians, pharmacists and data specialists most with postgraduate qualifications all contributing to our team in a very positive and productive manner and all passionate about science, medical research and technology.
How did you assist in professional development of other scientists in the industry through involvement in ARCS?
I remember attending one of the first social wine and cheese functions organised by ARCS soon after it started back in 1984. However, it was not until I attended my first overseas pharmaceutical conference in 1989, having won the ARCS Osmond Russell Scholarship, that I came across ‘CROs’ which were only just in their infancy as was the process of dealing with clinical data. Following this experience, I set up the ARCS Data Management Special Interest Group and for the next 10 years organised several meetings a year where we had a great forum to discuss the latest in dealing with clinical data. The first meetings were often wine and snacks at our house at Abbotsford or the
Sydney Rowing Club and later we expanded to include Biostatistics and had formal meetings at ARCS venue at North Ryde. Every year we would organise at least 4 meetings and one year we conducted a full day meeting at the Old Quarantine Hospital to discuss diverse technologies used outside our industry to collect data.
What recent requirements and technology changes have affected clinical data management?
For many years there was great interest in the need to have an electronic audit trail on each piece of data and electronic/bionic signatures on databases and everyone in data management became familiar with 21CFR Part 11. CDISC emerged to ensure a common variable format in clinical databases. As more ‘off the shelf’ software, EDC and ePRO systems became available the interest in discussing data collection systems at ARCS started to diminish.
With the growth of Datapharm how did you evolve from a home-based to office based company?
For the first few years we worked in various rooms from our old timber cottage in Abbotsford, moving in 1991, to a larger house also in Abbotsford with a free standing granny flat at the rear which we converted to our office. Having outgrown the ‘home office’ in 1998 we found the ideal office location in Drummoyne opposite Drummoyne Primary School, beneath the historic water ‘Tank’ and next door to a heritage butcher’s shop.
By 2005 to cope with our ever growing team, John built a new extension opening to the rear lane of our offices that has passed the local heritage tick of approval, is three levels, accommodates our stats and programming team in one section and monitors in the other, has a ground level meeting/training area. Over the years we also expanded regionally with offices in Brisbane and home based in Melbourne with regional monitors in Adelaide and Perth as needed.
Have you noticed a change in clients over the years?
Over the last 25 years, there has been a huge shift in our client base and in working relationships. In the early days of Datapharm our clients were predominantly scientists who were assisting and advising ‘big pharma’ on regulatory and clinical projects . The ‘big pharma’ had existing systems and expectations as to what they required and were happy to outsource to ‘consultants’ as needed on hourly rates for work done. There was a mutual respect for each other; there were no contracts; we supported each other in sharing of ‘know-how’; we were all keen to improve medical knowledge; and we all worked diligently to achieve our objectives. Our need to keep abreast of shifting regulatory requirements as scientists in the industry sparked the setting up of ARCS where participating in networking sessions encouraged us to share our knowledge of all aspects of our industry with a great sense of volunteerism.
With the emergence of conferences and exhibition stands, consultants and CROs needed to market their services, recruiters were competing to control the flow of skilled staff and training became a commodity. There was a boom in the local need for clinical data management and some multinational ‘pharma’ companies set up large data management and stats groups in-house with the assistance of the Australian government grants such as P3, however eventually most of these groups were shifted off shore to India and China. ‘Big pharma’ now tend to contract out their major clinical trials to large global CROs, having ‘preferred providers’. Currently, ‘Not-For-Profit’ organisations are burgeoning within Universities and hospitals where they conduct contract research competing with local CROs.
Today’s clients seek several proposals for CRO services using RFP templates, usually expecting the competing CROs to perform site feasibility for the study before submitting the RFP response. There are rigorous and time-consuming vendor selection processes including audits and sometimes ‘bid defence’ meetings to attend. The project milestones and budget for outsourced work are always tightly specified within a services agreement. The client project manager may have no scientific or clinical expertise and is often more focussed on cost than clinical or technical issues that arise in the project. It is not unusual for some clients to default on their payments of invoices whilst expecting services to continue, even ASX listed clients! Unfortunately with the added legalistic contractual layer, the old mantra of transparency, honesty, sharing of risk, trust and a desire to have a successful, quality project can be lost.
How have regulations and funding changed a CRO’s role over the years?
Meanwhile the biotechnology and medical device industry has expanded in Australia, with forums and lobbying supported by AusBiotech and BIO internationally. Our client base has shifted to working with many of these biotech companies ranging from some straight out of academia which are almost virtual organisations to others listed on the stock exchange. Many are conducting early phase studies in Australia and benefit from our ‘know-how’ and experience as most need to outsource their clinical research programs.
Clinical trial activity in Australia has waxed and waned relative to the change in regulatory requirements and incentives. Back in the ‘80s we needed to submit a CTX application to use an unapproved drug in a trial. When our regulatory processes in Australia improved, following the Baume report, which introduced the CTN scheme, clinical trial activity in Australia began to flourish.
Over the years there have been some government incentives for research, some of which were stopped before they had much impact. It is disappointing now that differing State government funding, interest and incentives and lack of national harmonisation continues to create an unequal playing field in the area of clinical trials. It is hoped that the recent AusIndustry 45% R&D Tax Incentive will provide more incentive for our biotech companies to continue to perform clinical trials in Australia.
Well, how did we go over 25 yrs?
Finally, given all the changes experienced over the last 25 years, how have we survived? An ability to multi-task and remain flexible, has allowed us to adapt to the changing technology, processes, regulations and clients. I must say, though, that all credit goes to our intelligent, passionate and energetic team and family whose support over the years, allowed us to grow from a fledgling consultancy to a successful full service CRO.