Clinical research standardization effort is saving money

Effort could save industry billions

For about seven years, clinical research leaders and the FDA have collaborated to develop research submission data standards in an effort to improve clinical trial efficiency, reduce costs, and cut delays.

"We're all volunteers," says Mary Lenzen, BA, MS, a principal consultant with Octagon Research Solutions Inc. of Wayne, PA. Octagon Research is a leader of electronic transformation of clinical research and development and is a service provider for the pharmaceutical industry.

"The standard we produced is SDTM — Study Data Tabulation Model for electronic submissions," Lenzen says.

The nonprofit organization called CDISC (Clinical Data Interchange Standards Consortium), located online at cdisc.org, is focused on establishing worldwide, industry standards, Lenzen says.

Lenzen says clinical trial data standards could shave months and millions off the cycle of bringing a new drug to market.

The SDTM is being used by some companies to transmit information to the FDA, and it's expected to become a regulation within the next few years. The FDA published a Federal Register notice about standardized electronic study data on April 24, 2006. The notice said that the FDA is proposing to amend the regulations governing the format in which clinical study data are submitted for new drug applications, and other applications.

As of June, 2006, the FDA had received seven submissions using SDTM, Lenzen says.

"This is the closest we've come to an industry standard for clinical trials," Lenzen says. "It's expected to reach into healthcare and not just clinical trials."

Since there is no industry standard, most research companies create their own standards, so when SDTM becomes the industry standard, these companies will need to adapt to the new standards, Lenzen says.

Octagon has already assisted SDTM conversions for 54 studies in the areas of oncology, central nervous system, cardiovascular, and endocrinology, Lenzen says.

The benefits to individual research organizations who implement SDTM conversions depend on how much they change, Lenzen notes.

"The earlier you go upstream, the more impact it will have on internal processes, including work flow, data collection systems, and analysis programs," Lenzen says. "Right now, because most people have legacy data and have not implemented SDTM at the data collection point, they're making the conversion right before submission."

However, there are a number of benefits to organizations that implement SDTM early in the process, including quality improvements and efficiencies, Lenzen says.

For clinical trial institutions that plan to implement SDTM at the point of submission, they'll first have to understand what they're going to map and what resources they'll need, Lenzen says.

"An understanding of source data is important," Lenzen says. "They'll need to find a commercial product or develop their own, but the hardest part is the mapping."

For example, if an organization decides to include gender as part of a demographics data set, conforming this to SDTM, then there are some choices in terms used, including gender and sex. And there are values assigned to the term sex, including male or female, Lenzen explains.

"Your database might have had this in numbers or with male spelled out and female spelled out," Lenzen says. "Or it could be A for male and B for female."

So the key is to look at the structure, list the responses you have, and then have this mapped to SDTM structure and terminology, Lenzen says.

"It can be two-fold: You may have called it gender in your database, but it's called sex in SDTM," she adds. "Mapping is making your structure and terms fit into theirs."

For organizations that are not standardized, the change could be very time consuming, Lenzen notes.

"When you lack standards, the more time it's going to take because you have this variety to deal with within your own company," she explains. "So for companies that are products of mergers and acquisitions, that's a real challenge because they inevitably had more than one standard based on the fact there was a standard or acquisition."

Once the data are mapped to SDTM and data are submitted to the FDA, the impact is all positive, Lenzen says.

"The FDA knows what to expect for the data because of the standard format, and they know what the target is for each company," Lenzen says. "Everyone is talking the same language and working off the same specifications."

Although the standardization submission regulations still are a few years away, many research organizations are starting to think about making the change, Lenzen says.

"If I was starting my own little company for pharmaceutical or biotech purposes, I would start with those standards," Lenzen says.

Existing companies will need to plan for the change, and there is no way to predict how long it will take or how much it will cost, Lenzen says.