Unprecedented time for the rare disease community

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Daniel Lewi

Mon Mar 16 2020 13:30:00 GMT+0000 (Coordinated Universal Time)

The COVID-19 outbreak may cause an unprecedented opportunity for the rare disease community in how we approach clinical trials.

The COVID-19 outbreak may cause an unprecedented opportunity for the rare disease community in how we approach clinical trials.


The immediate fear to the health of our vulnerable members of society, the elderly and immunosuppressed is clear. But there is also a long-term effect that will impact on our health in the inevitable delay to clinical trials and drug development beyond a vaccine.


Clinical research in rare disease will almost certainly be affected over the next few months by the COVID-19 crisis.


In the short term, this is highly likely to lead to a decrease in clinical trial recruitment, delayed or cancelled site visits which will in turn lead to numerous protocol deviations and violations that will result in countless queries or revisions.


The burden on the research team will increase markedly where precious times and resources will be devoted to these tasks rather than trying to accelerate clinical investigations to make up for lost time.

The rare disease community cannot afford these delays or the unnecessary risks to hospital clinics where exposure to viruses are high.


As a community, we need to rethink and restructure the rare disease research process and procedures that contribute to data collection, patient experience and safety. This is an opportunity to break through some of the long-standing inertia, archaic working practices and “small-p” political barriers which has hindered the introduction of capturing  patient data remotely and undertaking assessments that can lead to decentralised studies.


The personal and economic impact of COIVD-19 will no doubt be devastating and there is little that we can do now to prevent that now. However, we hope that this will be an opportunity to re-set and re-start the clinical trial experience and patients’ clinical pathways in a remote, digitally enabled and safe way.

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