Raising the stakes: Recruiting for a COVID-19 clinical trial.
As the coronavirus pandemic continues to change our society in unprecedented ways, scientists and pharmaceutical companies are hard at work trying to find new treatment options as quickly – and safely – as possible. And now, Crowley Webb is contributing to the search.
Our Praxis division was recently selected to help a major pharmaceutical company recruit patients for an upcoming clinical trial investigating a potential COVID-19 treatment. Every clinical trial we help recruit for is important, and this one feels especially significant.
New treatment options for this devastating disease can’t come soon enough, but it still takes a lot of time and research to develop new medicines. Here’s an overview of how the process works.
The early stages of testing a treatment.
Once a promising drug candidate is discovered, study protocols are established and guidelines for the different phases of clinical research are outlined. Every clinical research study is different, but they all have one thing in common – the need for participants.
Our Praxis division specializes in patient recruitment. We work to understand the study details, identify any barriers for recruitment, and figure out how to best reach potential participants. Then, we create compelling work that resonates with patients, facilitate patient enrollment, and help manage and motivate the various study sites involved.
It cannot be overstated how important it is to be able to effectively and quickly recruit eligible patients for clinical trials. Without participants, moving forward with clinical research wouldn’t be possible.
Understanding the clinical research process.
The clinical research process typically takes years, but this amount of time is necessary to help ensure a potential new treatment is both safe and effective. Out of the thousands of new drugs tested each year, only a small fraction of them eventually make it to market.
Phase 0 trials are the first trials conducted on humans. These are very small trials that help give scientists and researchers a better understanding of how a drug affects people and is processed by the body.
Phase 1 trials aim to determine the best dosage of a potential new medication – a dose that is small enough to reduce the likelihood of side effects but large enough to be effective. According to the FDA, around 70% of drugs move on to phase 2.
Phase 2 trials are the first trials that focus on the effectiveness of a potential treatment as well as its safety. These trials recruit a slightly larger number of participants than the previous phases. The FDA says roughly one-third of drugs tested in this phase make it to phase 3.
Phase 3 trials involve a large number of participants. These volunteers are enrolled and randomized, and the drug is often compared to a placebo to prove its effectiveness. This phase of research is often the last hurdle new drugs face before being considered for approval. Once a drug demonstrates both safety and efficacy in a phase 3 trial, the results can be submitted to the FDA. These trials are monitored closely by the government, and far fewer than half of the drugs that make it this far actually receive approval.
Phase 4 trials are ongoing studies conducted with hundreds or even thousands of people after a drug has entered the market. Even though the drug has already been approved by the FDA, these trials are important because large numbers of participants are often necessary to discover potential long-term or rare side effects.
Speeding up the timeline for a COVID-19 treatment.
When there is a great need for a new treatment, as is the case during the coronavirus pandemic, drug candidates can gain approval faster than usual. The FDA has programs in place to hasten the availability of promising treatments. These include prioritized review, accelerated approval, breakthrough therapy designation, and a fast-track program for drugs that treat serious conditions and fill an unmet medical need. You can learn more about these programs and how they work by visiting the FDA’s website.
The road ahead.
As you can tell, a lot goes into the development of new treatments – and the ability to enroll patients every step of the way can significantly alter the timeline. At the end of the day, no matter how expedited the review is for a potential COVID-19 treatment, the clinical trial process depends on participation. That’s why we’re so grateful for and eager to work on what could be our biggest patient recruitment opportunity yet.