Digital technologies are faster, less cumbersome to set up, and more patient-centric. They also provide better access to Real World Evidence, and thus enable virtual clinical trials. These siteless trials are offering a solution to the ever-increasing cost of clinical trials and a pathway for therapeutic innovation. Welcome to the future of medical research!
Pharmaceutical innovation is struggling. Investments in research and development have increased by about 50% in ten years; however, the number of new drugs approved by organizations like the FDA has stagnated over the last twenty years. This is partly due to clinical trials that are increasingly longer, difficult to implement and expensive. Trials now account for about 75% of the expenses related to the development of a new molecule (drug). What if, instead of slowly collecting data via paper forms, we began to collect the countless digitalized data generated by these same patients, be it via a mobile personal health record, such as Andaman7, connected devices, questionnaires allowing the collection of live data (quality of life of the patient, symptoms, compliance with their treatment, ...) and Patient Reported Outcomes or PROs?
Maximizing patient engagement
Grouped under the name Virtual Clinical Trials (VCTs), this phenomenon is becoming a reality, and is now changing pharmaceutical research practices, particularly Phase 4 clinical trials. Less cumbersome from the administrative point of view, faster, and thus less expensive, these “in silico” studies can collect a much larger amount of information, which are often of better quality. They enable real-time monitoring, between site visits, for example, to deepen the knowledge of the drug and better assess its tolerance in the daily life of patients. VCT’s also facilitate patient access to clinical trials, and promote greater geographic diversity including rural, ethnic, as well as socio-economic areas.
Finally, in a context marked by a significant decrease in the participation in clinical trials, VCTs make it possible to maximize the patient's commitment and compliance in the clinical research process, by giving him or her a role in their own health and not just the role of a simple lab rat! It is the famous “Patient Centric” vision that has become a priority for all stakeholders involved in medical research, from pharmaceutical companies, to regulatory authorities, paying agencies, through health care professionals and the patients themselves.
REMOTE: The first virtual clinical trial
Some pharmaceutical players have seized the opportunity from these virtual clinical trials. Through its REMOTE (Research on Electronic Monitoring of OverActive Bladder Treatment Experience) study, Pfizer set up the first virtual randomized clinical trial, in 2011. Both the recruitment, consent, registration and data collection were organized using digital tools. With respect to overactive bladder syndrome, this Phase IV pilot project included, for example, a mobile phone and the use of the Web, allowing North American patients to participate in the trial without having to visit a clinical site. Unfortunately, the study was interrupted prematurely because of an insufficient recruitment rate due particularly to a rather long and complex recruitment process.
The study did, however, show that it was possible to organize a virtual randomized and patient-centric clinical trial that can be acceptable by a national health agency and ethics committees.
VERKKO : A European VCT
What’s significantly more positive is the VERKKO Virtual Clinical Study. Sponsored by Sanofi and organized in Finland. It is the first of its kind organized in Europe. It was designed to evaluate the effectiveness of a wireless glucometer on diabetic patients, all recruited via Facebook, without any visit to a clinical investigation site being required! Of the 74 patients, 70 finally agreed to take part in the study, giving an inclusion rate of 81%. Measured at the end of the trial, patient satisfaction was equally high: rated at 4.52 on a scale of 5. On average, the study conducted by Sanofi showed a patient retention rate of 97% and was 30% faster than a traditional trial.
Certainly, some areas of clinical research may not be ready for remote monitoring yet. There are also challenges to be overcome before the generalization of these type of clinical trials. Nevertheless, advanced solutions like Andaman7 offer a more than significant boost in this regard: it becomes easy to securely collect both the answers to questionnaires, as well as data from multiple connected devices, as well as those of the patient’s personal medical file. Andaman7 is also available in more than 20 languages. There is no doubt that virtual technology will contribute in the near future to improving the quality and cost of medical research.