Co-Authored by: Nidhi Bajpai
It is a self-evident fact that innovation in technology has taken the front page of all industrial sectors as it has always supported to get the output (desired result) in less time, reduced cost and with limited resources.
In line with this, the clinical research industry positively anticipates that technological innovation supported by organization-specific customized consultancy services can help limit the problems associated with the following challenges:
- Average cost to develop and gain marketing approval for a new drug (pegged at $2.558 billion) 
- 95% of drugs that enter clinical trials do not make it to the market 
It is forcing pharmaceutical R&D to look for innovation, to be not just more efficient but more effective as well. Many big pharmaceutical organizations have established precedence by being the first movers to adopt latest technological advancement to support next generation clinical trials. This has helped them achieve the following benefits:
- Future Scalability
- Regulatory compliance
- Single source of truth
- Real-time availability of data for getting timely business insights etc.
Trends suggest that next generation clinical trials will spiral around technological innovations, which will predominantly support patient centricity by deploying maximum possible ways for passive data collection. To drive success, these have to be embraced correctly with the support of veracious and experienced consulting partner.
Key to success is improving patient engagement, enabling eVisits collaboration portals, thereby reducing attrition and increasing patient adherence in a trial.
Patient Centricity in Clinical Trials
US FDA has pointed out that the theory of patient centricity is still not fully comprehended and implemented in clinical trials.
Actually, the patient centricity initiative should commence with clinical trial design as it includes the sphere around understanding the patient and the overall impact that they may have to face.
Study design should be done in a manner so that the overall procedures are less burdensome for the subjects. Same could be achieved by leveraging validated research methodologies based on analytics, which is MDR (Meta Data Repository) driven with standard logics built across various therapeutic areas. If needed, these logics can be subcategorized based on program, project or study. This will help optimize study protocols’ inclusion/exclusion criteria by application of correct analytics to test trial feasibility.
Health portals will also play the key role of enabling patient centricity by improving patient engagement. They will help in sharing relevant health tips and extensive introduction to the clinical trial to spread awareness about the study. The peripheral advantage is that these portals would also serve as forums based on therapeutic areas and provide access to the information about others (without divulging personal details) with similar disease condition(s), progression, experiences, and circumstances; also, to understand different options around their treatment. Relevant subjects (pick on chatter, talk and feeds) may know about these portals from their social media websites. The portal would have a back-end analytics engine that would share only relevant information based on the profile of the patient.
Patient engagement technology is critical to the needs of the pharmaceutical industry, and thus, patient centric clinical trials are the way forward.
Passive data capture in clinical trials
The future clinical trials will include studies which are designed to optimize passive data collection. This may indicate that only those technologies will sustain the test of time that support RWE (Real World Evidence) principles for data acquisition.
The paradigm shift is already happening and can be seen evolving itself through the use of Virtual Sites. In simple terms, virtual sites can be described as moving away from traditional sites and conducting clinical studies locally at patient’s home or community. This will not only reduce the burden for the patient but will also help in keeping positive enrollment rate in the trials.
Our extensive experience suggests that mHealth & eSource are the key enablers for promoting passive data collection. Some of the examples of such currently-used tools for direct source data capture are eICF, eConsent, ePRO, mobile app, connected sensors, tele-health platforms etc.
With the adoption of electronic source records by clinical research industry, a wide spectrum of opportunities of patient engagement can be explored. For example, lab data can give significant actionable insights and serve as the ground to reach out to the prospective subjects for trail awareness campaign. With the combination of lab data/EHR/EMR/claims data/social media data, the target subjects can be identified. They can then enroll into the portal for more information about the upcoming trial.
Informed and engaged patient will not only help achieve enrollment objectives for the study, but will have immense benefits for the subjects by providing access to latest therapy, early detection of disease, better management of existing disease, safer care, low cost and, most importantly, building the mutual trust between sponsor, investigator, patient and their families.
- Tufts CSDD Assessment of Cost to Develop and Win Marketing Approval for a New Drug Now Published, March 10, 2016. http://csdd.tufts.edu/news/complete_story/tufts_csdd_rd_cost_study_now_published
- Hartung T., Food for Thought Look Back in Anger – What Clinical Studies Tell Us About Preclinical Work, ALTEX, vol.30, no.3,275–291, 2013. https://www.ncbi.nlm.nih.gov/pubmed/23861075