LEVERAGING INFORMATION TECHNOLOGY FOR COLLABORATION IN CLINICAL TRIALS - Collaborative Computational Technologies for Biomedical Research - page 284

In addition, it takes a long time to get the results of particular trials due to
the lead time to recruit the trial participants, it often involves treatment over
a long period of time, and the lead time to monitor and gather reliable data
to analyze the long-term effects of a treatment. Patient recruitment and reten-
tion in clinical trials are widely recognized as the bottleneck in the new drug
development pipeline and is essential to conducting successful trials because
adequate enrollment provides a base for projected participation retention,
resulting in evaluative patient data.
At the same time, monitoring daily activities and collecting reliable and
accurate information and maintaining confi dentiality are important. Much of
the information collected is sensitive and personal data, and therefore the trial
participants need an assurance that the data collected will neither be accessed
by unauthorized people nor be misused outside the original intended
purposes.
More importantly, the trial process needs to adhere to the statutory regula-
tions for protection of personal privacy such as the Health Insurance Portability
and Accountability Act (HIPAA) in the United States or the European Union
(EU) Privacy Directives in the EU member countries. Although each country
has different regulations in the details for protection of personal privacy, the
main concept is the same: Protect by law any information that can be used to
identify a particular individual. Therefore, all personal information, such as
name, address, telephone number, photo, e-mail ID, social security or insurance
number, driver's license number, and bank account number, is legally pro-
tected by the federal statute.
Sharon Jameson [3] identifi ed the following challenges in clinical trials:
1. Improper management of informed consent to comply with the statutory
requirement for protection of personal privacy—protection of the human
research subject is the fi rst obligation by obtaining informed consent and
thoroughly documenting the associated process.
2. Failure to prevent or fi lter out inaccurate or falsifi ed data.
3. Failure to maintain adequate source documentation — source documen-
tation tells the story of the patient's experience while on trial and pro-
vides proof of oversight.
4. Failure to comply with protocols—failure to follow the protocol can
compromise patient safety and does compromise the integrity of the
study.
5. Delinquent or inaccurate data submission—multiple queries and late
data lead to no payment or delayed payment for the staff.
One of the most critical success factors of clinical trials can be summarized,
as Genevieve Frank pointed out in her paper “Current Challenges in Clinical
Trial Patient Recruitment and Enrollment” [1], as well-maintained open com-