Clinical Trial Continuity During the COVID-19 Pandemic

The clinical trial landscape has changed dramatically since the outbreak of COVID-19. 

Trial sites have closed, travel restrictions give rise to increasingly complex logistics, and there are many uncertainties around the reallocation of medical resources. 

For the clinical research industry, this is not business as usual. However, that doesn’t mean clinical trials can’t continue. Now is the time to work together to find a ‘new normal’. 

Innovation in the Face of Crisis

The coronavirus pandemic has forced healthcare to evolve more rapidly in just a few months than it has in the past three decades. The industry is innovating to embrace new ways to engage patients and deliver outstanding care, without putting patients at risk.

This is an opportunity to make beneficial changes to a system that is, in many ways, outdated. A new approach to clinical research is needed, one that truly understands the needs of the patients and puts them first throughout the whole clinical trial process.

With great challenges come new opportunities. Here are the key ways the industry is evolving to support sponsors, CROs, and most importantly, patients taking part in clinical trials during the COVID-19 pandemic. 

Home Healthcare for Clinical Trial Continuity

In many countries, patients are currently unable to leave their homes. This makes travel to and from a site, particularly in the case of international studies, impossible. Instead, we must find ways to safely and effectively carry out study visits in patients’ homes. 

Home healthcare reduces the risk of exposure to the COVID-19 virus while enabling you to continue providing a high level of patient care. Having a fully qualified nurse visit patients in their homes to perform clinical trial activities and obtain samples will allow you to continue your study remotely. 

Carrying out trial visits in the comfort of a patient’s own home enhances their experience throughout the whole clinical journey by providing convenience and peace of mind. This has a direct impact on recruitment and retention rates, as travel to and from a site, even outside of this pandemic, is cited as a key reason patients drop out or fail to register into clinical trials. 

Safe Transportation of Medications, Ancillaries and Samples 

For a decentralised trial to be effective, medications, ancillaries and samples must be safely transported to the patient. 

There are a range of ways this can be done to ensure the safe continuation of the trial:

  • Transport ambient or temperature-controlled medication and ancillary supplies from a site to the patient’s home (and return any cooling devices/packaging to the site, if cost-efficient)
  • Collect unused medications from the patient’s home and return them to a site for accountability
  • Pick up medication from the site and collect a delegated member of the study team and transport them to the patient’s home to dispense and administer treatment if required
  • Pick up samples from the patient’s designated collection address and deliver them to the site; or provide a car service to take an approved member of the clinical team to take samples and return to the site (for example, dried blood spot samples)

Connecting Through Technology

In the absence of in-person appointments, investigators and study nurses are contacting patients by phone or video call. For some patients, this is a better experience, as they may feel more comfortable talking to the doctor or nurse in their own home than they would in the hospital or clinic. 

Technologies such as eCOA (eClinical Outcomes Assessment) enable patients to complete diaries remotely using their tablet or smartphone to report on symptoms and general wellbeing. Some trials are also now using wearable/sensor devices to remotely capture biometric data such as blood pressure, oxygen levels, glucose levels. 

Technology provides a valuable opportunity to get in the patient’s world, and capture patient sentiment in real-time. This allows you to intervene and provide additional support if needed, before a patient drops out of the trial. 

Putting Patients First 

Since mdgroup was launched in 2002, we’ve been on a mission to revolutionise the way the life sciences industry approaches product development. We combine global clinical trial and home nursing expertise with cutting edge technologies to provide a complete clinical trial patient support solution, significantly reducing the burden of site participation. 

We remain agile and adaptable to the changing circumstances and we’re here to help you protect your patients and their families in any way we can. To discuss how we can help you help your patients email us at [email protected]