Blog – When Clinical Trials Fail

When clinical trials fail, there is always a sense of great disappointment amongst the staff who have been engaged throughout the study, before the study and after the study is completed, as they are often the first to find out and as they know that they are going to have to impart bad news to the participants.

The participants themselves, without whom of course no trial would ever be completed, have given a huge amount of their time, and hope as a result of their contribution that some positive finding will come from the trial. It is not an easy thing for them to feel that, despite their efforts, no successful outcome has been achieved from the study. The expectation in many cases is that a new treatment will have been discovered to be successful in relieving distressing symptoms. The disappointment of a trial failing is much greater than that which might be associated with the discovery that a person has been on placebo during a study, as many people recognise that this was an option before participating. They feel relieved when the “active” arm is demonstrated to show improvements over placebo, which makes any adverse events they experienced during the trial feel more tolerable.

Ongoing support in order to adjust to the fact that their participation has not led to a successful outcome is sometimes required, as is support to help them adjust to the termination of their contact with the personnel associated with the study. They may be aware for instance that contact with trial personnel will significantly exceed the time which they spend in contact with mainstream service personnels such as community nurses or medical staff. A sense of emptiness, or even that they are somehow being abandoned by services needs empathic dialogue, while discussions with mainstream services about how a seamless transition can be achieved is also necessary, particularly as mainstream services often have different criteria for contact than is the case for those involved in delivering clinical trials. But it is true to say that after involvement in one trial, some people will be keen to volunteer for another, in which case significant care is required to make sure that people’s expectations are managed and that they are not overburdened by the stresses and strains of repetitive visits associated with some very detailed clinical trials.

The consequences for staff are also potentially quite significant. In many clinical studies, staff have been taken on specifically to work in that study. And if the study stops early or fails, then their role may be at risk unless they can be placed into something within their skill set and of value to them. Financial consequences arise since studies often attract a significant budget, especially those sponsored by industry, and that budget, of course, disappears, leading to a significant strain on those providing clinical trials. If the unit has a large portfolio, this may be more easily managed, but where the portfolio is small or even if the failed trial is the first trial a unit has undertaken, one must be careful to manage financial expectations. It is essential to ensure that R&D financial services remain up to date on the progress of studies throughout and that any signs of potential failure are monitored carefully.

If there is a large portfolio, it may be possible to move staff into another study, but where the portfolio is small and/or specialized, it might be difficult to do so.

No one likes to see clinical trials fail, but it is a fact of life. The staff involved need to have their enthusiasm rekindled and this can be difficult if the unit in which they are working is not particularly cohesive.

Staff can be disappointed by their contribution ending in failure and may need encouragement to remain within a clinical trial setting.

First and foremost, we must always remember that it is the participants who are owed the greatest debt for their participation in clinical trials and it is only right that their expectations and follow-up are managed carefully, with full explanations of the reason for the failure of the clinical trial. However, the end result is not always the be all and end all of all trials. In many trials staff learn new skills and techniques which can make their unit more competitive in the delivery of highly complicated study portfolios and benefits their professional development. Trials might fail, but not all is lost.

Dr Peter Connelly

Author

Dr Peter Connelly is a retired Old Age Psychiatrist who spent much of his career in Tayside, helping to establish clinical trials for dementia and neuroprogressive disorders in Scotland. Now working with the Scottish Neuroprogressive and Dementia Network, he combines professional insight with personal experience as a former carer. In retirement, he enjoys music, golf, and time with his grandchildren.

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