The Growing Complexity of Clinical Trials Requires an SaaS-based Approach to Document Exchange
Lack of Control Puts Companies at Risk For an investigative site, keeping track of a growing number of study documents across multiple studies with multiple sponsors on different continents, in different time zones and using different languages is an arduous task. Exchanging information in this global environment is complicated and can increase the possibility of error. Without a reliable, timely method for tracking receipts and monitoring the status of documents, sponsors and CROs perpetuate redundant efforts, paperwork and trial delays. Worse yet, when inefficiencies cause allegations of non-compliance, sponsors and CROs put themselves at risk of:10
• lawsuits; •
increased public and regulatory scrutiny;
• criminal indictments; • damaged reputations; • •
difficulty in recruiting for future trials; interruption of the trial itself; and • delays in product launch.
However, in this increasingly complex and regulated environment, companies continue to use traditional, non-secure methods for reporting and notification. In the aforementioned survey, 67% of respondents reported using unsecured email as the primary method of document exchange with sponsors during clinical trials.9
Sixteen
per cent of respondents still send documents via post and 7% fax their documents. In areas of the world where overnight mail is still the dominant method for submitting time-sensitive reports, costs and time are added to the trial’s bottom line. With the stakes so high, the traditional means of exchanging and managing time-sensitive documents no longer seem to make sense.
Web-based Solutions Reduce Paper and Increase Efficiency
The advent of remote data entry (RDE) systems in the late 1980s began the trend towards eliminating the use of paper forms to collect clinical research data. This helped reduce errors and improve the sponsor’s ability to monitor studies and patients. Early RDE systems used software installed locally on a laptop computer to collect the patient data, which were then transmitted back to the sponsor via a modem or phone line. It was expensive for sponsors to supply, install and support the necessary hardware and software. In addition to this, medical practitioners complained about usability and space constraints when multiple laptops had to be managed by investigative sites simultaneously participating in more than one research study.
With the rise of the Internet in the mid-1990s, RDE systems began to be replaced by web-based electronic data capture (EDC) software. By taking RDE functionality and making it available through a web interface, EDC has enabled faster and more frequent access to clinical trial data. It has also eliminated the need for sponsors and CROs to install and support additional hardware and software. In turn, the advent of EDC systems has opened the door for other clinical trial solutions – which had previously been developed and sold as traditional licensed software – to move to a web-based model. Examples of such solutions include:
•
configurable software that maintains and manages the planning, preparation, performance and reporting of clinical trials;
DRUG DEVELOPMENT
Table 1: Number of Global Clinical Trials 1996*
North America Western Europe
12,174 1,899
Central and Eastern Europe 56 Latin America Asia
Rest of the world Total
98
108 218
14,553
2006* 14,555 3,923 1,793 1,095 1,054 617
23,037
*Source: Tufts Center for the Study of Drug Development. **Source:
clinicaltrials.gov website, June 2010.
Table 2: Global Distribution of Clinical Trials by Phase Phase I (%) Phase II (%) Phase III (%) Phase IV (%)
North America Europe Asia
Africa Central and
South America Middle East Pacific
70.03 17.14 6.27 0.80 1.61
2.05 2.11
59.24 20.83 9.24 1.59 3.67
2.62 2.83
Source: IntraLinks, June 2010, analysis of
clinicaltrials.gov Figure 1: Factors Most Often Causing Study Delays
50 40 30 20 10 0
49 41
35.62 24.49 17.82 3.90 8.46
4.40 5.31
41.75 31.40 13.95 2.44 4.56
3.66 2.22
2010** 51,768 22,315 5,748 2,778
10,790 2,397
91,002
26
26
25
Contract and budget
negotiation and approval
Patient
recruitment and enrolment
Protocol design and refinement
Legal review IRB review and approval
IRB = institutional review board. Source: CenterWatch Survey, 2009. • •
clinical data management systems that code, verify and manage the clinical trial data gathered at the investigative site; and
electronic patient-reported outcome (ePro) solutions that have replaced paper forms for collecting-patient data.
Across the board, web-based solutions deliver a number of critical benefits to biotechnology, pharmaceutical and medical device companies. These include:
• • •
anytime, anywhere access: web-based solutions can be accessed anytime from anywhere;
faster data access: electronic transfer of data and documents is faster than paper-based methods, enabling faster and improved analysis of data from multiple locations and faster workflow;
reduced costs: the expense of purchasing multiple software licenses, installing programs and training staff is eliminated if companies use in-house software; companies will also reduce costs if they are use traditional methods to exchange information
51
% of sites
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