This March PharmaOut attended the Marcus Evans Evolution Summit, an entirely virtual event that brought together pharmaceutical and biotech executives to collaborate and share changes within the industry. The Marcus Evans team did an excellent job of making this virtual event both interactive and informative. A common theme of the presentations were Clinical Trials Post COVID. Leading industry experts shared their experiences and key takeaways about running clinical trials while adhering to COVID guidelines. There is a lot we have learned due to the COVID pandemic. As we implement new methods to run trials remotely, we can continue to learn from one another and use our findings to benefit the innovation within the industry and the patient population across the globe. Here are some of our takeaways from the changes we have seen in the clinical trial space:

Diversity, Inclusion and Equity in Clinical Trials

Diversity within the clinical trial space is an especially important conversation to have because it is evident that the participants of many clinical trials are not reflective of those most often afflicted with the disease. For example, black, latin, asian, and native americans are more likely to be impacted by COVID-19 but they are less likely to participate in any COVID related clinical trials. Statistics from a panel discussion at the BIO Conference in 2019 reported that racial and ethnic minorities make up 39% of the population of the US but only 2%-16% are reported to participate in clinical trials. This lack of diversity within clinical trials makes it difficult to get an accurate picture of a drug’s safety and efficacy. It is necessary that the healthcare industry as a whole makes a conscious effort to ensure that there is equal access to clinical trials for individuals of all races and economic status. Steps we can take to make sure we are running inclusive clinical trials are implementing bias training, increasing patient access to those in underserved areas and promoting language inclusivity.

The Site Experience of Operating through the COVID-19 Pandemic 

Clinical trials were drastically impacted from the moment lockdown began. When it wasn’t an option to have their trial patients come on site, research team members found themselves in a difficult position and had to find a solution that would keep themselves and their patients safe while also continuing their studies. With remote monitoring there were a number of issues that arose, a few examples:

• Some patients didn’t have internet access to receive email instruction.
• If trial conductors wanted to ship investigational products to a patient’s home they would have to ensure they were complying with the state’s pharmaceutical licensing laws.

Researchers had to implement these unprecedented changes to conduct remote trials while also maintaining standard trial protocol and following through with the IRB in a timely manner.

Although it was reported that about half of the clinical trials in 2020 (25 of 53) had fewer than 300 patients, the innovative trial teams and determined patients saw their trials to the end even through the hardships.

Remote Monitoring during the COVID-19 Pandemic

As we dive deeper into how to continue to run trials remotely, we must understand how to reduce the risk we acquire when implementing remote monitoring. RBQM or risk based quality management requires a combination of central, remote and on-site monitoring. The article Telemedicine and e-Health states, “The traditional belief that a face-to-face visit is necessary for health care has been changed forever and telemedicine is ready. Remote monitoring is one of the three main forms of telemedicine that appears most apt to handle the type of screening and informational challenges that COVID-19 presents.” As we move towards more remote monitoring practices we must always prioritize patient safety. It is important to capture all COVID related deviations and make sure employees are trained to document them and sponsors are able to answer questions from auditors and inspectors. Citing these deviations is crucial to data integrity and the overall success of remote monitoring. By leveraging technology, increasing collaboration between sponsors, vendors, trial monitors and patients, and documenting changes due to COVID-19, we can continue remote monitoring even beyond the pandemic in hopes of increasing access and producing more treatment options for patients.

The PharmaOut team remains committed to doing our part to fight COVID-19 and help keep our families safe. Our team of expert recruiters and consultants have years of experience to assist our clients in successfully continuing their business with our staffing, consulting, HR and investigator meeting services. Please contact us if you would like to discuss how PharmaOut can be your strategic partner.

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