Clinical Trials and the challenges faced during the Coronavirus Pandemic

There are over 170 entries in the US National Library of Medicine Database, found when we search for Coronavirus at Clinicaltrials.gov. There are promising developments at a rapid pace.

However, in the face of an all hands-on deck approach against COVID-19, critical drugs and therapies in the trial stage are facing major delays in approval.

1. Hospitals and Clinics running trials are collapsing trying to accommodate COVID-19 patients. Biotech and drug companies are currently running more than 120 Phase 3 clinical trials (Clinicaltrials.gov). Coronavirus impact for patients and the drug and medical devices industry could be disastrous. The FDA and other regulatory agencies are facilitating and creating incentives but without critical data from the trials, drug filings and approvals will be delayed.
2. There will be less patients willing to enroll in clinical trials. With the current pretty much global shut down and the fear of contagion, patients who would have otherwise signed up for a trial might think twice before going to a clinic or simply (because of quarantine restrictions) would not be allowed to participate.
3. Data collection from ongoing clinical trials is becoming a challenge. Non critical activities, even for labs, have been mostly suspended at a global level. Not being able to access the data because of poor digitization strategy or simply lack of access to a trial site will delay processing of the data and create an analysis backlog.

The current scenario looks dreadful for biotech and pharma companies with extensive drug/device development pipelines. The only way to mitigate is to focus on digital activities.

• Make sure you focus your short-term investment in digitalization of data initiatives that might allow your clinical trial team to perform as much work as possible from remote locations.
• Have all activities that can be done outside of the site streamlined and in full acceleration mode, so when you are allowed back into the clinical trial site you are one step ahead.
• Make sure you have a strong translation team for your global trials. Prepare and have all protocols ready for translation and perform QA and review so the translated documentation is of high quality and it becomes a white flagged process instead of an additional threat for further delays.

The standards and strategy for clinical trials translations are very important, since these can be compromised by a single error. Working with a language service partner that has the right experience and understands the regulations in different countries will provide you with the solutions for submissions

Idea Translations has helped organizations such as Merck, Monteverde, Brouwer Labs, Bristol Myers-Squibb and Cochlear with the translation of critical regulatory and clinical trial content. Learn more about our clinical trial translations by contacting us.