Speeding UP Clinical Trials

Speeding UP Clinical Trials

MAGI members represent more than 100 life science organizations, including Duke Clinical Research Institute, ICON Clinical Research, ImClone Systems, ISIS Pharmaceuticals, PPD Development, Quintiles Transnational, Stanford University and the Veteran’s Administration. The organizations have come together to help develop a flexible, multiple-choice CTA template that will suit the needs of both clinical sites and sponsors.

“In a 2002 study, the Association of Clinical Research Professionals (ACRP) asked about the most challenging steps in study start-up and the two biggest challenges cited were clinical study agreements and IRB negotiations,” said Richard Jenkins, General Manager for Life Sciences at IntraLinks. “MAGI members are using IntraLinks to collaborate to create a standard study agreement that can be used across all studies and all sponsors, eliminating the need to negotiate the same details every time a study is started. The vision is that you’ll be able to negotiate study agreements electronically and, eventually, sign them electronically, shortening the process and taking away much of the administrative burden for both parties.”

Norman Goldfarb, President and CEO of First Clinical Research and Chairman of MAGI, said speeding the clinical trial initiation process will benefit sponsors, clinical sites, CROs and patients.

“As it stands today, every sponsor has its own clinical trial agreement,” Goldfarb said. “They all say pretty much the same thing, but they say it in a million different ways – and not always in the clearest way. They use legalese and different nomenclature and they order the paragraphs differently – so just trying to figure out what each contract says is a real challenge.”

To address the problem, Goldfarb set out recruit others to help him create an industry-wide solution.
“An industry-wide agreement has two big benefits,” he said. “First, it helps all of the companies in the industry – not just the sites, but also the sponsors. Second, and most importantly, it helps the public. The slogan of our organization is: ‘We can agree to save lives.’ Reducing contract negotiation means we can get life-saving drugs to the market quicker – and that’s a motivator for me.”

With the existing contract negotiation process, it takes sponsors, on average, 35 days to secure an agreement with community-based sites and about 96 days to reach an agreement with academic centers.

“We estimate that we can speed that up by at least 2 weeks and by as much as 80% in some cases,” Goldfarb said. “When you figure that every day of delay in approving a drug costs a drug company an average of $1.3 million, if we save two weeks, we’re talking serious money.”

Goldfarb said the response from investigative sites has been “fabulous,” with more than 100 organizations signing on to IntraLinks to participate in the process of developing a standard template for clinical agreements. Even CROs readily see the benefits, he said.

“Sponsors understand the benefits in principle,” Goldfarb said, “but they get bogged down in the practicalities of corporate legal departments and so on. As we develop the text, which will be very flexible with multiple-choice options, the sponsors will see that it’s not scary and they’ll realize the sites prefer it, because they’re all going to be asking for it. MAGI member sites are conducting more than 18,000 clinical studies, so it’s going to be a lot of project managers saying ‘please use the MAGI language’.”