Addressing clinical development challenges amidst COVID-19
Things to consider when establishing R&D priorities as the world addresses the COVID-19 crisis
There is no doubt that the current public health crisis of COVID-19 is impacting the clinical research world. In the months since it was discovered, dozens of clinical trials aimed at treating, diagnosing and preventing COVID-19 and SARS-CoV-2 have been launched around the world. These trials launched with speed and efficiency that underscores the collaborative capabilities of the healthcare industry. Beyond research, healthcare resources are being diverted to cover immediate pandemic-related needs. These actions play a crucial role in addressing safety concerns and limiting the spread of the disease.
As the COVID-19 situation continues to evolve, trial sites and sponsors are grappling with the impact on ongoing and upcoming clinical trials. The well-being of trial participants remains the top priority, with every effort being made to lessen the impact of the disease. While subject safety is prioritized, researchers are searching for solutions that minimize study disruption and data loss. Health Decisions offers these tips for addressing study activities during this difficult time.
Implement procedural changes to protect subject safety
The current environment is creating barriers to conducting routine study procedures, particularly as it relates to site visits. In many cases, changes must be implemented to avoid added risk to trial participants, and regulatory and health authority guidelines are flexing to allow researchers to take extra safety precautions. As much as possible, alternative processes should remain consistent with a study protocol. However, when new contingency measures are implemented, document them carefully, noting how restrictions related to COVID-19 led to changes in study conduct. Ensure that contingency plans address concerns regarding data loss and validity and are mindful of new potential burdens on subjects and site staff.
Be transparent and communicate thoughtfully
Research processes are changing rapidly. In addition, site staff, trial subjects, and other stakeholders are likely adjusting to significant changes in their personal lives. Being thoughtful in study communications will go a long way. Clearly communicate how and why new processes are being implemented. Provide systems for submitting questions and getting additional support.
Address study components that will enable more efficient study start up
Travel bans, stay-at-home orders, and other restrictions are limiting patient and staff access to study sites. As a result, it’s possible that planned studies will see timelines shift. Taking time now to ensure protocol language is operational and conduct maintenance reviews of standard operating procedures and template documents will ease study start up when the time comes.
Evaluate the evolving clinical research landscape
To ease the burdens of COVID-19, the healthcare industry is innovating rapidly, predominantly in areas like remote monitoring and telemedicine. The methods currently being adopted have the potential to evolve industry standards.
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