As per regulatory guidelines, clinical research is important in order to develop new therapies and diagnostic procedures as well as to understand how diseases begin and progress. Due to multiple process involved in drug discovery and development it takes an average of 12 years for an experimental drug to travel from the laboratory to your medicine cabinet with costs in excess of $2 billion – if it even makes it to market.
The practice of conducting clinical trails initiated almost 60 years ago (1962 – USA Kefauver-Harris amendment to the law (requirement to prove safety and efficacy before issuing MA), since the 1980s, there have been limited changes to how drugs are developed in their clinical development. The current practice of clinical trials is running almost the same way as it was done when it started.
The world and technology, on the other hand, are passing our industry by and digital tools continue to advance. There is a need for new model to incorporate into clinical trials, making them more efficient, safe, convenient, and cost-effective by using today’s technology and digital health platforms.
One such model in clinical trials transformation is incorporating more virtual/hybrid trials and decentralized research into clinical development for better integrate healthcare into patients’ real lives and accelerate approval of new medications.
In recent years the FDA has demonstrated an open stance towards new ideas and technology innovations. With the issuance of new guidance such as the Digital Health Innovation Action Plan of 2019, the agency acknowledged that “digital technology has been driving a revolution in healthcare” and indicated that use of smart phones, social networks, and internet applications providing innovative ways for us to monitor health and well-being should be used more broadly.
The FDA-sponsored Clinical Trial Transformation Initiative has published recommendations for conducting decentralized clinical trials through telemedicine and mobile healthcare providers.
Current clinical research model:
Traditional trials are trials that are 100% site-dependent.
Activities conducted onsite include:
- Periodic patient visits
- Laboratory tests
- Drug distribution
- Device allocation
- Physician consultation
- Nurse and site staff assistance
- Patient-related data collection
- In-person informed consent
Drawbacks of current model:
- Require many on-site procedures that take up patients’ time and the average patient cannot take one day off each week to participate in a trial—as a result, today’s trials are not in line with the standard of care.
- The majority of protocols today have two to five times the number of procedures or visits a patient would receive for their disease management in the normal course of care. As a consequence, this makes the patient burden too high, making it difficult to recruit and retain clinical trial participants.
- Patients must journey to sites that may be far from their homes—an average travel of two to three hours—when they could instead pick up a prescription at a nearby pharmacy. As a result, only about three to five percent of eligible patients get to enroll in clinical research and there is a 30% dropout rate for those who do enroll across all clinical trials.
- Studies show that about 75% of people preferred a mobile trial over a traditional trial, and 80% of patients are more likely to take part in a trial that uses mobile technology.
What are Hybrid Trials?
Hybrid trials are trials where the site dependence varies.
Activities conducted onsite or offsite include:
- Patient check-ins
- Routine tests conducted
- Drug distribution
- Device allocation or shipment
- Physician consultation
- Combination of virtual and onsite consulting
- Nurse and site staff assistance
- Combination of mobile nursing, telemedicine, and onsite nursing
- Patient-related data collection
- In-person or using eSource
What are Decentralised trials?
Fully Virtual, Mobile or Decentralized Trials are trials where there is no site dependence, but meta-sites exist:
- Utilize telehealth and telemedicine
- Patients do not visit sites
- Mobile healthcare providers are allies
- Tests conducted virtually, at community laboratories or mobile nurse-aided facilities
- Drugs and devices are shipped to patients’ houses
- Virtual physician consultation—text, audio, video
- Virtual/in-home nurse assistance
- 24/7 patient support
- Patient-related data is collected virtually or mobile healthcare providers-aided
- Telehealth or mobile informed consent
Benefits of decentralised trials:
- Maximizing patient recruitment with regional, state, or country virtual models.
- Using virtual and hybrid trials to reduce cost and resources with siteless, distributed, and hybrid clinical site models.
- Through their device, the patient would have access to caregivers, CRC/Site (for day-to-day patient management, oversight, and engagement), sponsor and CRO (oversight of study management, concierge services, and study analytics), mobile HCPs (home or work visits for participants screening and follow up visits), and PI/HCPs (telemedicine visits, AE management and assessment, clinical oversight).
- It provides real-time patient data insights, enrollment insights—dashboards show what is/not working and when to stop recruitment.
- De-risk trials in real-time—compliant patients, fewer patients needed, faster database lock.
- Enhanced patient safety—clinical team alerted to adverse events as soon as they occur, direct to patient notification.
References:
- Digital Health Innovation Action Plan of 2019
- Clinical Trials Transformation Initiative. 2020. Decentralized Clinical Trials.
Hi Ramya, thank you for creating this site, its really helpful.
I wanted to ask if interacting with external case processing vendors and analyzing quality metrics of vendors is part of drug safety specialists job in a pharma setting? Is there any good link where I can read up more about this, would be appreciated.
Also is there information on how to create pharmacovigilance agreements with external partners?
Thank you, will wait for your reply.