RISKS ARE INHERENT IN INTERNET-BASED TRIALS, EXPERTS SAY

Clinical trials practitioners are finding the Internet improves efficiency and communications, but security gaps and regulatory weaknesses can counteract the technology's substantial benefits, experts said.

"The strengths of using the Internet include the ubiquity of access ... for clinical trial sites and subjects, the ability to globally deploy and -- most importantly -- change and test a software application from a central location, all of which reduces cycle time, improves data quality and reduces costs," said David Hardison, vice president of the Life Sciences Division at SAIC, a research company based in San Diego.

"In the coming years, the Internet's ability to make data that is collected at multiple locations worldwide available to individuals and organizations that are separate and globally dispersed has the potential to positively impact the efficiency of all phases of product development," said Munish Mehra, senior vice president of clinical research services at Medifacts International, a clinical trial services firm. However, as with any burgeoning technology, the Internet can pose serious risks to the clinical trials industry.

"The primary weakness is not the Internet per se, but the regulations governing the conduct of clinical trials," Hardison told FDAnews. "The current regulations were written from a paper-based paradigm versus electronic. This has slowed adoption by the risk-averse pharmaceutical industry. The good news, however, is that efforts are under way to change the regulations to reflect today's reality while still maintaining the ethical and scientific integrity of the conduct of clinical trials."

Practitioners must address regulatory concerns, agreed Lisa Olson, principal consultant at SEC Associates, a validation and compliance consulting company in Morrisville, N.C. For example, "storing the [case report form (CRF)] data in only one place on the sponsor's server may not adhere to the [good clinical practice] regulations, which require that investigators maintain the data," she told FDAnews.

The quick data availability the Internet offers can be a detriment, Olson said. "Sometimes companies are doing inappropriate early 'looks' and analyses of the data, and then making adjustments in the trial. This should not be occurring; the protocol defines the study, its parameters and how the data will be analyzed."

Another downside to using the Internet for the conduct of clinical trials is its openness, Olson said. "It is an unprotected data stream that is open to anyone viewing, copying or potentially changing data in transit. Thus, it becomes important to put adequate security controls and access mechanisms in place. Viruses and other computer 'disruptions' are rampant, and protections need to be implemented against those."