Patient recruitment and sustained enrollment is absolutely essential to the success of drug development. However, it’s been shown that nearly 80% of clinical trials fail to meet their enrollment deadlines. This is thought to be due to many reasons but since the traditional model of executing clinical trials includes engaging multiple study sites and coordination of multiple patient visits to the study sites, patient enrollment is an arduous task. In fact, travel time alone for patients to get to the doctor’s office can be a major barrier for obtaining patient data points throughout the trial.
Merging healthcare and technology
A modern way to combat this dilemma is merging healthcare and technology. Clinical trial sponsors are starting to implement the use of apps, monitoring devices, online social engagement platforms, etc. to recruit and retain patients in clinical trials. In fact, Novartis just landed a deal with a LA-start-up to launch a virtual clinical trial. Virtual clinical trials is a broad term that includes various stages of a clinical trial – recruitments, informed consent, counseling, and measuring clinical endpoints and adverse reactions – which can be conducted in the comfort of the patient’s home.
Benefits of virtual clinical trials
Maximize patient recruitment and enrollment
Increase awareness throughout patient advocacy groups, etc.
Sustaining patient enrollment throughout the duration of the study
Ease of reporting
No travel issues
Facilitate adaptive clinical trial approaches to trial design
Real-time and exhausted clinical data
Risks of virtual clinical trials
Impending regulatory issues
In the development of new drugs, serious adverse events (SAEs), including death, will occur. In these situations the FDA will need to determine how to deal with these cases and the method of reporting..
The most important risk of a trial is how to maintain the effectiveness and integrity of data obtained during the trial. Self-reporting may augment this risk.