Costs of the drug development have been estimated in billions of dollar and sponsors are looking for the ways to reduce these costs and to provide drugs to the patients in a more efficient manner and being conscious about the costs.
Way to reduce cost:
Remote clinical trials is the way to reduce drug development cost in which there are less investigation sites participating in the study that are named as coordinating site. Number of coordinating sites depends upon the size of the study and these sites can be across the country and region. This trial process is for controlling the financial cost of the drug development.
Remote VS traditional clinical trial:
In remote clinical trials, a lot of the procedures, protocols and visits are done directly with the patients. There are digital aspects of remote trials in which different digital apps, products and equipments are used by the patients for the study and they don’t have to visit the investigation site. While in traditional clinical trials, the patients have to be on study site and CROs and sponsor have their CRA and in-house CRAs for monitoring of the clinical trials at site.
Potential cost savings:
Remote trials provide opportunity to reduce costs through:
1. Number of investigator sites are reduced that saves the site costs, startup fees and for overhead of sites.
2. This also completely reduces the site monitoring and management staff associated with sites as in traditional protocols where there are a lot of monitors, PIs and study coordinators. This saves a huge amount of money for the sponsors.
3. Visits are done digitally through apps and digital equipments that also help in collecting all the data virtually instead of visiting the study site that also reduces the costs.
4. Patient travel cost also reduces.
5. Patient recruitment and retention is done digitally through social media that reduces the costs.
Initial financial challenges while implementing new digital clinical trial method are given as below:
1. There should be a coordination and partnership with the vendors and companies who can help collecting and saving all the data associated with the clinical trial.
2. Required equipments and technology to be used by the patients require investment that can also be managed through partnering with a vendor.
3. Starting new remote clinical trial will take a learning curve in initial trials that will take time by the sponsors, study team to learn new digital ways due to which trials will be slow at first and also require some professional training that will also cost.
Physicians should also be involved within the drug development process that will make them comfortable to recommend those drugs to their patients.