Increasing Access to Clinical Trials and Vaccines, It has always been a common scenario. That whenever there is a change there is inertia, resistance and chaos at the beginning. The same pattern holds when there is a disaster, calamity or a crisis. The pandemic is one good example.
However, following every change there is hope with trial and error, planned structure and standardized stability. The analogy for this in the medical world can be compared to clinical trials, Scale-up Manufacturing and distribution & access to test / devices / drug administration.
Innovate – Bringing Clinical Trial Access Home through Convenience Models
One of the key solutions to bring innovative medicines to market is improving access to increasing access to clinical trials and vaccines participation. An interesting multi-site study, published in 2020, showed an increase in trial enrollment with the adoption of mobile technology and mobile services in 71% of the sites. The study was conducted in the US for over a period of 18 months.
The decentralized trial approach has been talked about over a decade. Still the pandemic has actually brought the trend a little closure. If we cannot bring participants to the sites, bring clinical research home, by opting mobile services. This provides convenience and enables participants to stay throughout the trial at their convenient time. Without getting exposed to the risk of infections at clinics.
The use of mobile services has enabled clinical trial access. Not just on the technology front for remote monitoring, but also on the services. A hospital setup can also be made at the participants home for critically ill patients. Hospital-at-home models also increase participation of geriatric participants who are not able to come to the sites.
A number of companies such as Medically Home Inc., Contessa have invested in that space and have expanded nationally. If we need to get better results for innovative vaccines and products to reach the market, increased patient retention and participation is the need of the hour.
Adoption: Scaleup Manufacturing Capacity through Strategic Tie-ups with CMOs
There has been divided opinions in the industry on meeting the demands of covid-19 vaccines by technology transfer to other companies to produce more vaccines. An interesting comparison can be made with the approach done by Hamied of Cipla in the early 1990’s when AIDS was at its peak. In order to make the drugs affordable, Hamied agreed to cut the costs of the expensive drugs to $1/day to increase market access to HIV patients.
As indicated above there was criticism in the EU commission, (Inertia), then there was scaling up of manufacturing with strategic tie-ups (Planned structure), followed by stable administration of the proven drug to curtail the rapid spread of the infection.
It is a well established model and a proven concept, that innovators and manufacturers can outsource the production of drugs / vaccines to Contract Manufacturing Organizations (CMOs) in non-regulated markets to meet the supply demand gap especially in the time of crisis. The IP debate will be part of any product whether it is a drug / vaccine, diagnostic test or methodology.
In the interest of health, if the entire scientific community can come together with such adoption of strategic tie-ups. There will be increased market access of the required medication and curtail the pandemic faster
Engage: Patient Support Groups and Mobile services to enable Remote Access to Vaccines
If the first two parts are achieved. The last part and the most critical part is to increase market access of vaccines to the patients and public. There are many patient support enabled services which facilitate outreach, logistics and travel access to the patients in remote locations. While registrations are being done on the government websites and third party enablers are enhancing user experience. The same can be engaged with the mobile services.
If the vaccines / tests need to reach the patients faster and in remote locations, mobile events and campaigns are one of the best options. Distribution of vaccines with engagement models of fully managed support services including At-Home vaccine administration can accelerate to cover larger populations.
Conclusion – Together We Win !
There has been no evidence in the history of science or mankind that individual groups have won standalone. We can certainly win over the pandemic and the crisis, if each of the above groups mentioned in the article can come together and strategize the Innovate, adopt and engage model harmoniously. The innovation of clinical trials, adoption of technology through strategic tie-ups with companies, together with engagement of fully managed mobile services is the key solution.
About the Author:
Srinivas Sashidhar – Business Head – Clinical Research Division at myOnsite Healthcare. He comes with 12+ years experience; targeting assignments in Business Development / Business Planning / Market Research in the Healthcare and Life Sciences industry.
Contact Srinivas at: