Medical Device, Pharmaceutical and other companies that develop new products usually require successful clinical trials and often spend hundreds of millions of dollars to bring their product to market. Certainly, research and development activities are an expensive component, but another major component is the conducting of clinical trials. Clinical trials (Phases 1-3) typically cost in the $50-70M range. This can be even more expensive and time consuming if it is difficult to recruit and retain patients on the trial.
From a patient perspective, Clinical Trials are often a last resort for a terminal disease or a disease they have been fighting for years, - or perhaps their quality of life is so poor they will try “anything” to overcome their illness. However, most current recruiting, on-boarding and ongoing patient management processes leave patients participating on clinical trials uneducated or under educated about the trial, risks and possible side effects.
Organizations conducting clinical trials often overlook the importance of engaging or “involving” patients in the trial process so not only are outcomes optimized for the trial, but also for each patient that is participating. This lack of understanding often results in patients “quitting” a trial and a direct contributing factor to patient loss from a trial.
Consider the following: (1)
Nearly 80% of all clinical studies fail to finish on time, and 20% of those are delayed for six months or more
85% of clinical trials fail to retain enough patients
The average dropout rate across all clinical trials is around 30%
Over two-thirds of sites fail to meet original patient enrollment for a given trial
Addressing the above issues, the Willowglade Technologies Personalized Patient Experience Platform (PPEP) is designed to facilitate the education, monitoring, engagement and “involvement” of patients who are participating on clinical trials.
A first for the industry, PPEP is a unified platform with many functions including:
Patient and Clinician reported inclusion / exclusion criteria data capture
Electronic Informed Consent (eIC)
Patient Reported Outcomes (ePRO)
Clinician Reported Outcomes (eClin RO)
Observer Reported Outcomes (eObs RO)
Electronic Data Capture (EDC)
Patient specific education
Patient Monitoring and Alerts
Investigator / Patient Communication and Collaboration
Patient / Supporter Communication and Collaboration
Medication Compliance Monitoring
Alternative platforms are fragmented and offer a limited range of functions for patients in clinical trials. PPEP elevates this to a new industry level resulting in:
Enhanced Patient Recruitment
Scalable, time saving and efficient Electronic Informed Consent
Outcomes reporting capabilities across Patients, Clinicians and Observers resulting in an accelerated understanding of overall patient outcomes
Collection of data from wearable or other in home patient devices on a unified platform
Monitoring and alerting of patient “out of range” situations where intervention is necessary.
The PPEP Unified Patient Involvement Platform aims to address key issues regarding the cost-effective management of clinical trials. To learn more about Willowglade PPEP and about the many ways Willowglade Technologies is changing the electronic relationship between patients and healthcare organizations, please feel free to visit our website or contact us at email@example.com
(1) http://www.clinicalleader.com/doc/considerations-for-improving-patient-0001 and