Technological innovations and the future of clinical trials

Of course all of these challenges have solutions, and it seems likely that many of the answers lie with innovative technologies. If we think about the clinical trials conducted today, it would be almost unimaginable to plan or conduct them without some level of computer power.

The rapidly evolving world of IT has had a significant impact on data collection and processing in clinical research, and this technology revolution has enabled real savings in term of cost and time, in the drug and device development industry (9).

Social media

In the coming years, the clinical trials industry will focus its attention ever more on increasing technological sophistication (9). The FDA is already making strides in publishing recommendations on the use of social media (9). Many companies like Abbvie and Pfizer use their Twitter accounts to engage with patients and the clinical community (9).

Not everyone looks upon the rising use of social media favorably. Pfizer’s head of Clinical Innovation for Worldwide R&D, Craig Lipset, has suggested that the use of social media is ‘unblinding’ clinical trials, with clinical trial participants discussing their treatment on social media and potentially coaching one another, compromising trial integrity (12). The use of blogs, Facebook and Internet forums to discuss clinical trials may all have a damaging effect on data integrity, and there is no easy remedy for this situation (12).

However there are many benefits to social media, the pharmaceutical research can take advantage of (12). Pharma companies and FDA are constantly trying to find ways to harness the power of social media, while keeping the best interest of patients, trials and the clinical research system, at heart (9).

Hardware

Other aspects of developing IT technologies, such as smartphones, the cloud and big data innovations, also show great potential for use by the clinical trials industry. For instance, the Misfit Wearables is delivering a small wearable disc that can be attached to clothing and can capture all the vital data needed to create and accurate map of activity and exercise (9). Mobile Health Monitoring is another area that could also bring significant insights to CROs as a way to gather data on subjects without bearing the cost of expensive monitoring (9). Additionally, to the technological improvements and possibilities, risk-based monitoring and inspection using innovative strategies and tools show great promise (4, 11).

Genomics

A number of national programs have been established to help predict efficacy of treatment based on an individual’s genome (4). The Federal Government announced a program to map the genomes of newborn babies to provide information on how they will metabolize medicines, react to certain foods and their susceptibility to certain childhood diseases (4). This is an enormous step, moving us forward into the age of “personalized medicine”: an era in which treatments will be tailored to the individual characteristics, needs, and preferences of patients during all stages of care; prevention, diagnosis, treatment and follow-up (10).

Summary

It’s clear that today’s advancing technology will have an enormous influence on clinical research. Improvement in diagnostic methods will allow practitioners to personalize their prescriptions, whilst, innovative tools and devices that will allow constant health data collection, risk-based monitoring and inspection are likely just around the corner.

Whatever the future brings, new innovations must fulfill three basic criteria: to be more adaptable to patients needs, more effective and less expensive.

References:

1. http://clinicaltrials.gov/ct2/resources/trends
2. http://clinicaltrials.gov/ct2/search/map
3. https://www.clinicaltrialsregister.eu/ctr-search/search;jsessionid=rSoo935D_vEy308nOXCRMNw_kf3W6iA96WzqrpTtl_HczC9jhIuo!-376466626
4. http://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM378499.pdf
5. http://www.who.int/ictrp/network/en/
6. http://www.anzctr.org.au/docs/Monthly%20Website%20Reporting_Statistics%20Sep14.pdf
7. http://www.chictr.org/en/registry.aspx
8. http://www.ensaiosclinicos.gov.br/about/
9. http://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM378499.pdf
10. http://www.fda.gov/scienceresearch/specialtopics/personalizedmedicine/default.htm
11. http://www.totalbiopharma.com/2014/07/03/top-5-trends-clinical-partnering-outsourcing/
12. http://www.totalbiopharma.com/2014/06/10/social-media-compromising-clinical-trials/