Our new normal includes the era of COVID-19 in clinical trials and all of the ways that this pandemic has altered the way we look toward the future and the steps we take within our paid clinical trials. The reality is that the impact of COVID-19 significantly affects how clinical trials are and will be conducted.
As we look forward, safety is definitely one of the factors most affected by COVID-19 in clinical trials. Doctors and researchers have, without a doubt, been forced to take a harder look at how safety is addressed within clinical trials for patients and their families.
There is and will continue to be a greater use of personal protective equipment, as well as more consideration of the virtual and remote possibilities within paid clinical trials. Clinical trials will be safer with new perspectives of sponsors and the Food and Drug Administration – which encourage and approve telehealth visits and remote lab assessments, imaging and other testing, as well as the allowance for taking a certain amount of missed visits into account and making adjustments to clinical trials based on those missed visits.
These virtual and remote testing advancements will lend themselves to better communication within the world of clinical trials, as it will be required for their success. It is also believed that the guidance directed toward the clinical trial industry will be more patient-centered, with increased flexibility and engagement.
Certain clinical trial challenges associated with the impacts of the COVID-19 pandemic, such as self-isolation, self-imposed and non-self-imposed travel restrictions, clinical trial facility closures and interruption of certain investigational product supply chains, have all tested the clinical trial process and led to difficulties including medicine administration and mandatory testing and visits.
In an effort to help ensure the safety of clinical trial volunteers while maintaining trial integrity, the Food and Drug Administration has also developed protocols for clinical trial information and recommendation dissemination. Part of this effort includes working with other agencies and issuing clinical trial guidance and the regulation of medical products during the pandemic.
The effect of the COVID-19 pandemic on clinical trials can vary depending upon where you are planning to participate in a clinical trial. For instance, certain regions that have been hit harder by the pandemic than others may be slower to enroll new patients for clinical trials. In fact, they may have even put a temporary hold on accepting new clinical trial patients.
Furthermore, if there are any risks of COVID-19 exposure, trials have been delayed, cancelled or switched to phone or video conferences. However, the great importance of clinical trials is a known quantity, ensuring that the continuance of them is closely monitored with the ultimate goal of keeping as many studies open as possible.
In certain instances, as with processes like certain physical exams or drawing blood, your actual healthcare provider may be performing certain tasks as opposed to the clinicians who normally would within a regularly planned clinical trial. Plus, certain clinical trial medications may now be shipped directly to individuals who are participating in clinical trials. All this is done in an effort to eliminate the necessity of visits to the clinical trial research facility.
And while addressing the effects that the COVID-19 pandemic will have on paid clinical trials, let’s not forget the economic impact. Global economic uncertainty caused by COVID-19 may also play a pivotal role in the number of future clinical trials that can be conducted, as well as the success of those clinical trials.
In May of 2020, a study of 300,000 clinical trial sites throughout the world was conducted by Phesi. What was discovered was a 38 percent drop in the number of clinical trials so far that year. Further analysis later last year indicated that, thankfully, the number of clinical trials is on the rise once again.
As one might imagine, with the limiting of clinical trials comes delays in research and development of a wide array of potential medical and therapeutic advancements. In fact, it should also be noted that due to the increased speed at which COVID-19 vaccination research was conducted as well as abbreviated sample sizes of COVID-19 clinical trials, initial research may not bring all variables to light. Of course, researchers are calling for expanded COVID-19 clinical trials and studies to determine the long-term effects of COVID-19.
Today, researchers are also calling for clinical trials for items like rapamycin. Rapamycin is an antibiotic hoped to be used for successful COVID-19 treatment approaches. In tandem with vaccination efforts, researchers are also attempting to expand investigations of convalescent plasma therapy, which has already been proven to be safe. The hopes are to mitigate symptoms in COVID-19 outpatients and even possibly prevent the contraction of COVID-19 after exposure.
Clinical trials were created to improve our lives. Now, as we look toward the future, paid clinical trials will take on the arduous task of better ensuring the safety of the volunteers who participate in clinical trials, their families and the physicians and medical personnel who treat them within their particular clinical research studies.
In addition, there is hope that the knowledge we have gained from addressing the insidious nature of the coronavirus will also lead to the research and development of better therapeutics, medicines, prevention, cures and advocacy programs and support for patients and their families.
If you are interested in becoming a clinical trial volunteer to join the fight against COVID-19, feel free to contact Riverside Clinical Research at 386-428-7730 Monday through Thursday from 7 a.m. to 5 p.m. or Friday from 7 a.m. to 12 p.m. You can also email any questions to firstname.lastname@example.org. Riverside Clinical Research volunteers are paid for their efforts and they are sometimes able to benefit from innovative medical treatments before they are made available to the general public. There are no costs for the medical procedures or treatments provided by the medical professionals at Riverside Clinical Research and there is no insurance necessary to participate.