How does COVID-19 affect clinical trials?

Paving the Way to Innovation

What impact has COVID-19 had on clinical trials? Latinos in Clinical Research took on that topic recently, concluding that not everything that has happened in the past year was bad. In fact, out of necessity, some situations that were perceived as negative paved the way for innovation and efficiency.

Initially, patients were afraid to engage in clinical trials, and participants went down by 60 percent. Clinical researchers had to learn how to perform more procedures remotely, which — at least temporarily — meant more work for the research sites.

While 80 percent of clinical researchers prefer onsite visits, they have learned how to improve their capabilities. Cloud-based software for life sciences companies, such as Veeva, will become more important. Sites have learned how to utilize safety measures to enable them to take on lucrative COVID-19 studies while protecting personnel in all studies.

Because of COVID-19, drug manufacturers had to expedite production of vaccines. Synthetic m RNA vaccines can be produced in days or hours, leading to a paradigm shift in the way vaccines are produced.

Many doctors experienced declining numbers of patients in their offices during the pandemic, because patients were afraid of exposure. While there was less access to healthcare, there was more opportunity for research in those offices.

Now that 20 percent of the population is vaccinated, the worst is over, and some states are completely open. Meanwhile, clinical researchers are learning new skills, such as handling protocols when patients are having a bad reaction to a vaccination.

Some sponsors have had to change protocols ,such as determining whether or not a subject can have the vaccine. There also will be more treatment studies. Undoubtedly, there will be more opportunities to test vaccines made from m RNA for other indications beyond COVID-19.

New studies have been launched on COVID and other indications. While budgets were at 60 percent of pre-COVID levels for other studies, there are more studies than ever before when COVID is factored into the equation.

As of now, vaccinations are not available for everybody. Clinical researchers are wondering whether to make vaccinations mandatory for employees and subjects and what impact that decision will have on patient recruitment.

Telehealth is now a part of clinical research. Many providers have it in place, knowing that they need backup plans. About 70 percent of clinical trial sponsors have adopted new technology for e-feasibility and remote monitoring.

Data companies are going to win. Five major CROs do 80 percent of the studies, while the other 100 do 20 percent of the studies. High-tech vendors are getting better at what they do.

Still, studies show that face-to-face contact is important in connecting with people to make them comfortable. It is necessary to have support staff to teach people how to do electronic diaries and other technical things, even when studies are remote.

Of necessity, studies will become more innovative and efficient as clinical researchers rise to the challenge.