Blog – My First Clinical Trial: Lessons Learned

I was involved in my first clinical trial in 2005 when a pharmaceutical company asked my colleague, a consultant old age psychiatrist who had experience in trials, if he would be willing to pull a team together to run a clinical trial. This was long before there were disease specific clinical research networks in the area. Crucially, this trial required the research staff to have expert knowledge about dementia.

We were gathered as a group to discuss whether we could do this – all of us were primarily clinicians – 2 medics and 2 nurses. I was the designated clinical trial coordinator – a role I had never done before.

We were able to screen potential participants from both of the medics clinic lists and apply the inclusion and exclusion criteria to the potential participants. We told the pharma company (the Sponsor) that we could recruit 4 and that is the number we ended up recruiting.

All of us attended our first Investigator Meeting in Vienna, which was a complete culture shock to us NHS employees, as this was a no-expense spared meeting which had us each being handed a 50 Euro note in an envelope on arrival, as our plane was delayed and we had missed dinner. The next evening, seeing the Vienna Boys Choir, being taken to lavish restaurants with copious amounts of food and drink (remember this was 2005), in return for our compulsory attendance at the most tedious lectures about how to perform the most basic of trial activities. Due to the compulsory consumption of all that ‘free’ alcohol and food, the 8am to 5pm days in enclosed – no fresh air or sunlight allowed – rooms were particularly hard going! Lectures included: how to perform the Mini Mental State Examination (MMSE) which as clinicians we knew very well. The difference was how the sponsor wanted us perform it, consistency being the key – for 2 hours; being marked on our ability to perform the Clinical Dementia Rating scale and what it means to be a blinded rater for 5 hours.

Learning all about the ADAS-COG (The Alzheimer Disease Assessment Scale -Cognitive Subscale) – i do not recall how many hours but it was many.

The most tedious lecture I can still remember vividly, 20 years later, as the one where they instructed us on how to put blood bottles in a bag and then to use the correct labelling for the bag and to put that bag into a box and send it off with a courier. There was a separate lecture for handling dry ice. I didn’t realise until the study was under way that this would become the bane of my research life.

We returned to base and worked out who would be doing which scales and who the blinded rater would be. The company approved our choices based on the results of the tests back in Vienna. We then organised our first screening visit. This was where things started to go badly wrong. We vastly underestimated the amount of time needed for each screening visit and if we could do it again, we would have only asked one of the participants to come along, rather than all 4 staggering them by 1 hour. It was a complete disaster, and ran way over time. We hadn’t ordered food for anyone. There was no time to offer anything other than a cup of water. The courier arrived to pick up bloods that hadn’t been taken, the participants were waiting for hours to be seen, we, the staff, were completely overwhelmed with the amount to be done for each participant and their accompanying carer.

Our subsequent visits were much better organised and we were able to carry out the visits and assessments in comfort for everyone concerned, partipants and staff, as well as organise all the assessments and write up following each visit.

I mentioned earlier that dry ice was my biggest headache. All the samples which had to be sent on dry ice, were going to a lab in Switzerland. This required knowledge of airway bills, storage and handling of dry ice but most importantly, a hot line to the carrier. Ice had to arrive on the day of the visit to the correct hospital and be picked up a few hours later. As we were using two community hospital in more rural locations to see participants, the ice had to be delivered and picked up there. Sometimes there was no receptionist and the package would be returned – no dry ice. Sometimes the carrier would deny all knowledge of the hospitals’ existences’ and there would be no dry ice. Sometimes, it would not arrive on time or the courier would arrive too early to pick up the package and would refuse to wait. The most memorable occasion, the ice had arrived the day before and had shared the night in a hospital morgue, with an unfortunate companion.

What we learned: Over compensate for time- Allow breaks for the participants and staff. Ensure there are refreshment facilities for everyone. Organisation is key – the right staff, doing the right assessments, with the right participants, with the right paperwork, in the right place.  Check and check again with the carriers that they know where and when the dry ice is to be dropped off and collected. Do not expect lavish receptions at the Investigator Meetings – that has never happened since!

Dr Emma Law

Author

Dr Emma Law is Strategic Manager for the The Neuroprogressive and Dementia Network in Scotland. Emma has 13 years experience as a Clinical Trails Network Manager and over 35 years experience as a Nurse, many of which were spent in the delivery of Clinical Research Trials. Emma completed her PhD and is passionate about giving people living with dementia and their carers access to participate in research.