How Is COVID-19 Impacting Existing Clinical Trials?

Whilst attention is directed towards the unprecedented number of clinical trials launched worldwide in vital efforts to find an efficacious and safe treatment for patients infected with the novel coronavirus (SARS-CoV-2) – the huge impact COVID-19 is having on existing clinical trials is not receiving the same level of coverage.

Technology Networks recently had the pleasure of speaking with Panthera’s CEO Stuart Young to learn more about how the COVID-19 pandemic is impacting existing clinical trials, the affect social distancing is having in terms of participant–clinician interactions, and the guidelines regulatory agencies are putting in place to help ensure the successful continuation of clinical research in these uncertain times.

Laura Elizabeth Lansdowne (LL): For our readers that may be less familiar with Panthera, could you tell us a little more about the organization?

Stuart Young (SY): Panthera, an independent site management organization, was founded by Dr Ian Smith, founder of Synexus and Professor John Lyon, previously senior executive in Covance. Panthera opened its first research site in October 2019 to offer a better service to CROs and pharma clients. As well as offering sites for trials handled in primary care Panthera is in advanced discussions in terms of providing specialist secondary care sites for trials in neurology and oncology. Panthera is building a network of sites across the UK which will be followed by sites overseas. Two sites – Preston and North Manchester – are already open.

COVID-19 is having a very serious impact – with most trials being delayed or deferred. Patient safety is of paramount importance both to us and our sponsors, but we are remaining able to support customers both during the crises and of course afterwards.

LL: How will social distancing measures impact participant interactions with their clinician? What strategies are/will be in place to overcome the lack of face-to-face visits?

SY: At this time, running a site mixing with hospital or primary care patients significantly increases the risk to trial subjects, especially those who are in the vulnerable “at risk” categories.

Our North Manchester site is a stand-alone building with numerous car parking spaces. In this situation we are able to ask patients to remain in their car until the clinician is ready ensuring that there is no interaction with other patients and minimal contact with our staff.

In some trials it is possible to digitally interact with patients by video/phone, to deliver medications, take readings remotely etc.

However, the procedures of each clinical trial protocol must be carefully looked at and there are limitations to what procedures and assessments can be done remotely.

Home visits by a clinician is another route but this is highly inefficient.

Inevitably, the acute necessity generated by the COVID-19 pandemic has spawned a great deal of creativity, inventiveness and most importantly willingness to approach things differently. In the future I am sure that new studies will use more technology to reduce the need for visits however at present for the vast majority of existing protocols we see demand for and requirement of site visits.

LL: What precautionary measures are/will be put in place for participants considered to be in high-risk categories?

SY: In many cases high risk patients will not take part as enrolment is widely closed however anyone requiring a site visit will be isolated as much as possible to limit exposure. Personal protective equipment (PPE) is available and used where necessary. We will also not be accepting any sponsor visits to sites until further notice to reduce unnecessary risk.

We treat all of our patients as high risk, as many are elderly and/or have underlying conditions.

LL: Have the regulatory authorities provided any specific guidance and if so could you provide an overview?

SY: The US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare product Regulatory Agency (MHRA) have issued detailed guidelines. All of the agencies stress that the safety of patients is paramount and understand that deviations may increase. It may also be possible to move the site visits to a safer location or delegate remotely in instances where a Principal Investigator becomes ill.

The regulators have been incredibly understanding of the situation and the guidance is pragmatic. Do what is necessary but avoid risks where possible.

Further regulatory guidance on clinical trials during the COVID-19 pandemic can be found here:

• FDA – FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
• EMA – Guidance on the Management of Clinical Trials during the COVID-19 Pandemic
• MHRA – Advice for Management of Clinical Trials in Relation to Coronavirus

Stuart Young was speaking with Laura Elizabeth Lansdowne, Senior Science Writer for Technology Networks.