Patient safety during clinical drug administering remains the most important aspect to the clinical trial industry, especially during a global pandemic that has targeted the older generation and individuals suffering from preexisting conditions or immune deficiencies. Stay at home orders across the United States and much of the world, even going so far as to postpone elective surgeries for life threatening issues, have substantially impacted the ability of patients to show up at sites for their regimented dose. What does this mean for the future of more than 330,000 clinical trials listed on ClinicalTrials.gov?
It means more adaptive trials will be necessary to fulfill the demand in the market, and faster solutions for getting the industry back on track. There have been numerous delays starting new trials, coupled with diminishing data from lack of patient compliance and ability to show up at clinical sites1. The need for direct-to-patient trails, in home dosing and adapting ongoing protocols to include more remote monitoring of patient compliance, are the types of innovative solutions the world is demanding in an effort to mitigate trial participants and administrators risk2.
The task of adjusting protocols does not rest solely with the sponsor company and their strategic partners. The FDA will need to loosen its tight guidelines to allow for revisions to protocols in a timely manner. The arduous process of updating a protocol in the current environment is both tedious and time consuming, so a streamlined approach the FDA is comfortable with will be vital in maintaining accurate data collection for ongoing trials. The world is learning how to adapt and overcome everyday stressors that inhibit normal movement in our lives, and the clinical trial market is facing the same task.
Citation Healthcare Labels (CHL) has been fortunate to partner with a handful of existing and new clients to overcome the monumental task of fighting COVID-19. CHL continues to provide quick turn around and support, while adjusting our facility to accommodate the recommendations put forth by Governor Cuomo and the State of New York. We have made an amazingly fast shift to a more electronic based data platform. The result has been a reduction of our carbon footprint through less reliance on paper and proving that we can adapt to our clients’ needs as well as those of the world. Our team has succeeded in reducing standard label timelines for COVID study supplies by 50%, and we continue to collaborate with our partners on innovative strategies to ensure drug supplies are delivered to patients in a safe and time conscious manner.