Impact of COVID-19 on clinical trials
In December 2019, China was affected by several cases of what was considered a fatal viral pneumonia (1). The numbers of affected patients were exponentially increasing and on January 9th 2020 Chinese authorities made a preliminary determination of a novel coronavirus which became known as SARS-CoV-2 or COVID-19 (1). Not long after, on January 30th 2020 the World Health Organisation (WHO) declared the COVID-19 outbreak as a global emergency (2). This was just the beginning of a pandemic that has come to challenge all what we thought to be normal and forced us to adapt to a new reality - a new lifestyle. This new reality has also affected clinical research as resources given to human trials were diverted towards the pandemic response resulting in the termination, suspension or withdrawal of more than 1700 clinical trials worldwide (3). In addition, most of the ongoing studies have undergone substantial modifications in order to address the safety of participants, staff and investigators (4) and here at Profil we are proud to be at the forefront of finding answers to these new challenges.
Impact on our studies
Even though, as expected, some subjects have expressed their concerns with participating in our clinical trials, only very few decided to terminate their ongoing participation in a study. That said, COVID-19 did not have a negative impact in our recruitment process. Most subjects are willing to participate in new studies and/or remain in their respective studies.
As a company, Profil has shown concern about the safety of employees as well as study volunteers and has developed a strategy and advice on how to proceed with daily activities while encouraging to practice good hygiene and social distancing. The same was true with monitors and sponsor´s representatives and therefore a safety plan was developed. In spring, some sponsors decided to put a halt on the studies in order to assess the situation better, accepting a delay of study timelines in order to ensure maximum possible safety. Apart from that, we were able to continue with the studies with a great deal of normality. It is important to note that the “Lockdown” did not affect our ability to carry out our studies. Clinical research was one of the areas considered by the government as “fundamental” and therefore we were able to keep our premises open to participants. Civilians were encouraged to stay at home and they were able to go to work (when possible) and therefore also to participate in clinical trials.
Adapting / Evolving
Profil has been looking for ways to mitigate the impact that COVID-19 has had on the operative aspect of our clinical trials. It has been of utmost priority to meet expectations by authorities, sponsors, participants and our own staff to address safety concerns before moving forward with studies. We have looked for ways to adapt and to readjust our procedures to the new reality.
The first stage was to prevent the virus from “entering“ our company. These first steps were taken as early as March 2020. Wearing a mask became compulsory for everyone who was working in our clinic and to all of our study participants. Body temperature has been measured before entering the building and additional hand sanitizers were placed all over our premises. There were restrictions on the number of people allowed to be in a room at the same time and home office was advised when possible. Our participants were contacted by our recruitment department to make sure there were no symptoms before coming to their visits. Anyone (staff, participants, sponsors) who had any known symptom were advised to stay home and visit their primary physician if needed. These measurements proved to be successful and as the spread of the virus continued worldwide Profil´s strategy has also evolved.
The second stage began in September-October; the areas where masks became mandatory to use were expanded. Profil gained access to rapid (antigen) tests for COVID-19 and signed agreements with our local laboratory which enabled us to have PCR results in less than 24 hours. A COVID-19 rapid test is now performed on every patient before being admitted to an in-house stay. In order to minimize the contact with our staff and any other participant in our clinic before getting the results, the patients are asked to wait in a designated waiting area (without contact) until one staff / coordinator member would pick them up. This area offers good ventilation and the possibility of a private entrance so that there is no contact with other areas/members of our clinic. Body temperature is measured and entered in our source data when arriving and a quick test is performed by properly trained staff. After 20 minutes the results are in and only when negative, the patients are allowed to enter the rest of our premises. This information is entered in the source data of each patient. During their in-house period they are obliged to wear a mask when leaving their rooms and when any study intervention is performed.
In case a test result is positive, a contingency plan is put in place where a confirmatory (PCR) test is performed and every person who had contact with the subject is put into quarantine immediately. Staff members or subjects who had a contact with a positive-tested subject are tested again 3 and 5 days later after the contact, and the eventual return to work or participation in a study is evaluated individually. Special tasks were designed and selected staff are trained to perform COVID-19 related procedures.
What is yet to come...
We are evolving, following guidelines and finding ways to keep our work while giving the patients and sponsors the certainty that we are taking all the necessary measures to minimize the impact of COVID-19 on our clinical trials. We will keep adapting these measures and improving them in order to ensure the safety of our patients and to comply with the sponsors’ need for each specific trial.
Profil owns two clinics (in Neuss and Mainz) which together comprise of 85+ beds for in-house trials. We are in a privileged position to continue carrying out trials without much disruption. We are committed to fulfilling the needs of our clinical trials and contributing to the advancement of diabetes care; in times when these advances are more important than ever.