The current heath emergency caused by the pandemic has placed health systems around the world under extreme pressure. One of the biggest challenges that the industry faces is overcoming the inexperience of handling such a grave condition, one with few common symptoms. Implementing quarantine, physical distancing or self-isolation, noted as the best measure in avoiding contracting the virus, has created critical challenges in the conduct of clinical trials. The prime ones being:
- New recruitment
- Existing patient follow-up
- Staff availability as per guidelines and protocols
Another potential challenge is the impact of the infection on a patient’s existing condition, potentially leading to an outcome much different than the results predicted for that study. In conducting the trials, it is important to understand how the study treatment(s) being administered will interact with a patient diagnosed with COVID-19 and with the medication(s) given to them during the study. Infected patients can create deviations and require changes to trial protocols that were unforeseen during the study set up. This may be viewed a potential threat to the efficacy of the trial but may also lead to further insight and analysis into treatment and disease pathology.
The pathology of the COVID-19 virus involves hijacking the healthy cells and affecting the immune system after transmission. Such pre-established details about any clinical conditions (and information from the ongoing study) can be amalgamated with the critical details from previously assessed studies. This can provide insights into the nature of the medications and their impact on the human body. The point to be addressed is the use of data science to interpret, analyze, and predict the possible outcome of COVID-19 infected patients despite clinical sites being unable to collect data due to site closures or holds.
Clinical data repositories such as CDISC SHARE, MEDLINE, and many others can serve as reliable reference sources. For example, if study of a lung cancer study is on hold, the data from the ongoing study can be linked with data already present in the repository using standard meta-analysis methods. This interlinking can reveal if the drug is beneficial for more than one condition, bringing an opportunity to view data under a new lens despite quarantine guidelines.
As the COVID-19 story unfolds, it’s important for Sponsors and CROs to remain open to potential solutions. Presently, decentralized strategies, inclusive of remote/virtual trials, are a viable solution to move existing and future clinical trials forward. With the philosophy of “the show must go on,” being innovative and adaptive allows for the remote capture of all the possible data which can be extracted, while delays and challenges can be addressed and solved or minimized.
There have been certain accessions provided by healthcare leaders to manage the trials during the contagion, and if challenges continue, existing data from the cloud can be used to perform predictive analysis which may help the study in the future. This may not solve all the complications of the existing trial but may shine a light on new opportunities for efficacy and efficiency.
- Claudia C. Dobler, Kelvin Cheung, John Nguyen, Andrew Martin. Risk of tuberculosis in patients with solid cancers and haematological malignancies: a systematic review and meta-analysis. European Respiratory Journal 2017.