Blog – What makes a good clinical research team

I’ve worked with many clinical research teams as I was an experienced rater, including being a blinded rater – which means I neither knew if the participant was on study drug or placebo or knew any of the other study examination results –  for a number of Scottish sites and therefore worked with a number of teams. I was also the National Network manager for many years and therefore I was in contact with many of the Scottish teams big and small.

In clinical research each team may be working on a number of studies at one time. It is crucial that all the team members want to be part of the study they are undertaking and have in-depth knowledge about the study. This means that from the first approach from a company or vendor, the team are able to access, as best they can, as much information about the study and then the full protocol and all accompanying documents prior to the study starting up. This means that the team are able to assess whether they can actually deliver the study with the number of staff they have available and taking into account the number of studies they are currently working on.

A good team would meet as a group to discuss this through and talk through any complexities or obstacles they might see to preventing them delivering a particular study. That team will be able to recognise when a study is out with their capabilities and turn that study down.

A good team will assess whether they can bring in outside expertise to deliver particular aspects of the study.

They will know their own limitations and strengths and will have access to other departments who may be able to assist. An example of this is if the study requires the participants to have a complex procedure like a lumbar puncture. Are the clinicians who will be involved in the trial competent to carry this procedure out? Or do they have a clinician they can call on to assist? A good team will have various people they can rely on to assist for these types of scenarios as well as having a great network of people whom they can call on for advice. Good teams will then be able to fully assess whether the team and extended team have the competencies to complete the trial.

A good team will respect each other and each others strengths and limitations. They will be aware that there needs to be such things in place like holiday cover, or contingency cover for the unexpected events such as illness. This becomes a reality by communicating with each other about team members needing time off and then planning study visits to ensure expected and unexpected events do not stop the smooth running of a study.

The coordinator is central to this process and an effective coordinator is a great communicator. There are so many facets to the running of a study, and the coordinator will be central to this in ensuring everyone is aware of what their roles are. They will be the key player in the delivery of a study. In a good team they are respected within this key role.

The Principle Investigator (PI) takes on the role of being the person who takes responsibility for the overall study and its delivery but the coordinator is the person who ensures that everyone, including the participant, is in the right place, at the right time for each study visit and that any discrepancies are flagged to the PI as soon as possible.

The coordinator makes sure that everyone has completed the necessary training prior to starting a study, from each individual having an up-to-date Good Clinical Practice certificate, to study specific training plus signing non disclosure agreements and declaring any financial interests in the company running the study.

Within a good team this runs smoothly and everyone is aware, usually via the coordinator, which training and paperwork they must complete before a study can be allowed to begin. One person within a team, not completing what may seem like an unimportant piece of paperwork can hold up the start of a study. A good team will understand this and work as one to get all this done as quickly and smoothly as possible.

Finally what makes a good team…humour and compassion for your fellow team members! When things inevitably go wrong, and perhaps some of the team members have a bad day, being able to share these things with team mates and perhaps find the humour in this, can be cathartic for everyone.

In my years of experience a few of the many things which have happened which require humour and compassion in equal measure are: a taxi not turning up to bring a participant to a visit, and staff having to jump into their car to collect the participant. If not, the participant looses their scan slot or would not be able to reschedule for other reasons; Having no means of making the participant a simple cup of tea or a slice of toast because there are workmen are in the study kitchen; having an extended wait at pharmacy or study drugs which should have been ready to collect.

Some of the more serious issues such as a participant being excluded from a study because they were taking an over the counter drug which automatically excluded them and their resultant disappointment and upset; a study being stopped at 5pm due to the company deciding that their interim analysis was not showing any efficacy resulting in all the participants being told that the study had stopped with immediate effect; or a participant decides to withdraw with no discernible reason near the end of a study. All these scenarios have happened and a good team will support each other through these situations.

There can be some scenarios within the day to day delivery of a clinical trial which are harrowing and upsetting for all, to the more mundane and the downright dull such as the never ending paperwork, but being able to share these experiences with other team members and laugh or cry, commiserate or celebrate is what makes a great team!

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.