A snapshot on Information & Communication Technologies 

in Clinical Trials

• ICT (information and communications technologies) is an umbrella term that includes any communication device or application, encompassing: radio, television, cellular phones, computer and network hardware and software as well as the various services and applications associated with them, such as videoconferencing and distance learning. ICT are now present in our daily life. The technique, this extension of the human body, needs a supplement soul, as indicated Bergson, and now puts service to the world of health and especially of brain pathologies. In 2013 and 2014 the Innovation Alzheimer Workshop provided recommendation for the use of ICT in Alzheimer disease’s and related disorders (2013 article / 2014 article). In 2014, participants of the Workshop worked more specifically on the interest of ICT in research and most particularly for clinical trials. This document is a snapshot aiming at highlighting the most important topics to be debated. Information on definitions, scientific literature and survey results are provided according to the point of view of clinicians and other stakeholders working in the field. Do not hesitate to tell us your point of view and to add relevant information in order to update this document .

This document as been prepared by Valeria Manera, Guillaume Sacco, Alexandra Konig, Cassandre Landes, Justine Lemaire, Renaud David, David Bensamoun, François Bremond, Philippe Robert.

Research types: Definitions. 

• Clinical Trials aim at evaluating the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought.
  • Clinical research: Clinical research is a branch of healthcare science aiming to improve knowledge of either disease or therapeutic. Clinical research may address purely biological, but also the objectives of human and social sciences. Clinical research also aims to determine the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.
  • Translational Research: Translational research applies findings from basic science to enhance human health and well-being. For example, in medicine and nursing, it aims to « translate » findings in basic research into medical and nursing practice and meaningful health outcomes.
  • Basic research: is a systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena.

The different stage of clinical trials and the role of ICT :

– INVESTIGATOR’S TRAINING
– RECRUITMENT OF PARTICIPANTS
– ASSESSMENTS
– DATA ENTRY

INVESTIGATOR’S TRAINING

E-trainings for clinical trials are routinely used by top pharmaceutical companies and CROs in order to train the investigators and evaluate their competence and knowledge of the study procedures. Vote

Advantages
Easy to harmonize study procedures across sites
Lower cost
Less time consuming
Possibility to repeat the training, also for investigators entering an ongoing trial
Trainings available in long term  
Easy to adapt to the different languages / professional figures       
Possibility to show test and procedures        
Lower risk of bias due to procedure misunderstanding

Disadvantages
No personal interactions with study coordinators
No immediate question feedback
Technical and connection problems    
Possibility to cheat and ask others to do the training/tests     
Reticence of the investigators to be evaluated
Risk of work overload due to investigator’s formal evaluation
Less adapted to the ‘to do’ skills

Results of the votes (scale 0 – 10, from totally disagree to totally agree)
31 participants:
11 clinical domain (psychologist, MD)
3 researchers
2 ICT engineers
5 Business domain (pharmaceutical industry’s)
10 undergraduate student in medicine

RECRUITMENT OF PARTICIPANTS

• ICT can be employed in two ways:

• To recruit through existing databases, such as Electronic Health Records (EHR)

EHR are more and more employed in public and private practices. This can help patient recruitment, because databases can be used to screen eligible patients (inclusion and exclusion criteria).

References :
http://www.cdc.gov/nchs/data/databriefs/db143.htm
http://www.healthit.gov/sites/default/files/highlights_accomplishments_ehr_adoptionsummer2012_2.pdf
http://www.healthit.gov/sites/default/files/oncdatabrief9final.pdf
http://www.slideshare.net/logicaplc/market-study-of-electronic-medical-record-emr-systems-in-europe

• E-recruitment

• Nearly 100% of the studies conducted outside of North America use only standard approaches.
• In North America, 14% of studies rely on e-recruiting

References :
http://www.paconsulting.com/our-thinking/enhancing-clinical-trial-recruitment-using-social-intelligence/
http://onlinelibrary.wiley.com/doi/10.1111/1540-4560.00254/abstract?

ASSESSMENTS

ClinicalTrials.gov – a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world – contains at present (January 2015) more than 2500 clinical trials involving participants with Mild Cognitive Impairment (MCI), AD or other dementia types. We performed a keyword based search on these trials focusing on automated audio and video analysis techniques, actigraphy and computerized testing.

Keywords :
“audio analysis”, “speech analysis”, “audio recording”, “voice recording”,“voice recognition”, “video recording”, “video recognition”, “video analysis”, “3D recognition”, “accelerometer”, “actigraph” “actigraphy”, “motion sensor”, “computerized test/testing”, “computer test/testing”

Number of pharmacological clinical trials retrieved on clinicaltrials.gov

Actigraphy :

Computerized testing :

Audio and video analysis :

Results of the votes :

DATA ENTRY

• Top pharmaceutical companies and CROs (such as GlaxoSmithKline, Merck, Novartis) use eCRF in 100% of their trials.
• 2008 – 2009: 45% of small CRO used eCRF in more than 50% of their trials (Europe and Canada)
• There is evidence that studies employing eCRF are less expensive and require less time compared to study using the paper version of the eCRF (e.g., Le Jeannic et al., 2014)
• eCRF are regulated by FDA and EMEA, and has to follow strict rules concerning data security, data storage and data control

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2732224/
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0025348
http://www.ncbi.nlm.nih.gov/pubmed/19345286
http://www.sciencedirect.com/science/article/pii/S1551714409000445
http://www.biomedcentral.com/1471-2288/14/7