Views From The Front Line
During the unprecedented circumstances of the COVID-19 virus pandemic where people and patients around the world are being asked to stay at home (unless specifically affected by the virus or life-threatening health concerns), clinical teams are facing the challenge of continuing important research across many different disease states.
Both new and ongoing clinical trials are dramatically affected due to reduced patient and site access. With patient and healthcare provider safety being the paramount objective for sponsor companies during trials, what is the short- and longer-term future for clinical studies?
Six Degrees asked a number of clinical science directors, trial managers and site relationship managers from some of the world’s leading life sciences companies to share the issues they are facing in conducting patient research and possible solutions to these challenges. Here are their thoughts:
Top 3 issues facing clinical trial management right now
1. Many trial sites, clinics, and hospitals are focused on the momentous challenges of the COVID-19 pandemic and are no longer interested in conducting clinical research. Clinical research is very much secondary at the moment and is slowing down considerably and even coming to a halt at many sites.
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2. Many sites are not allowing on-site monitoring by sponsor companies to meet with patients, speak with doctors, conduct inventory, check informed consent procedures, etc. due to the fear of spreading the coronavirus at sites. In the case of new trials, the challenges are being able to get out to qualify sites and getting them to initiate studies. It’s nearly impossible to start a new study at the moment.
3. Many sites are not allowing patient visits for research (other than for COVID-19 research or treatment) as they don’t want to risk unnecessary exposure among immune-compromised patients. This presents the additional challenge of no longer being able to provide (most) study drugs to patients without risking exposure.
How can clinical teams overcome these challenges?
1. The industry will certainly come to the realization that many studies can’t go on for the time being. In the meantime, it is critical that sponsor companies be caring and supportive toward hospitals, clinics, and sites on the front lines of the pandemic.
2. Study-by-study management and enrollment practices will become the norm; interventional studies may have to stop until patients and monitors can safely return. Remote monitoring for some Phase 4 or observational studies may be possible, allowing doctors to conduct virtual visits by phone or web to monitor problems, symptoms, adverse events, etc.
3. Sponsor companies are exploring the potential for home monitoring visits and home delivery of research drugs (or pick-up by family members)
4. Sponsor companies are also exploring using local labs that don’t take COVID-19 patients to conduct trials, check-ups, and assessments
5. Sponsor companies are introducing or expanding the role of Site Relationship Managers to increase communication and assistance to trial sites to keep them assured and provide information, answers, and overall transparency.
It’s quite clear that clinical research may need to be paused or even canceled until its safe for research patients and monitors to return to hospitals and sites and for doctors to refocus on non-COVID-19 related initiatives. A big challenge facing sponsor companies will be helping the industry to overcome the reticence of patients, nurses, and doctors from returning to hospitals and sites out of fear of contamination and further spread of disease.
In the meantime, sponsor companies are focusing on maintaining open communication with sites, offering to provide assistance in any way they can. From a trial perspective, sponsor companies are continuing with planning and preparation, as well as the development of branding and communication tools to accelerate patient recruitment and enrollment in order to get their trials up and running as quickly as possible once the pandemic subsides.
Six Degrees remains available to assist sponsor companies with the development of integrated clinical trial branding programs and patient recruitment acceleration systems in preparation for your future trial start-up.
Use this hiatus to develop an effectively branded trial that stands out and appeals to patients, caregivers and health professionals when all clinical trials start up again and compete for attention.