MAGI uses IntraLinks to speed collaboration on standardized clinical trial agreements
MAGI members represent more than 100 life science organizations, including Duke Clinical Research Institute, ICON Clinical Research, ImClone Systems, ISIS Pharmaceuticals, PPD Development, Quintiles T
By on May 28, 2004MAGI 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'sll 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.'s 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'sre 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'sll realize the sites prefer it, because they'sre 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's.
IntraLinks's online collaboration tools give MAGI members an efficient and secure space in which to exchange ideas and review proposed wording for a standard template, Goldfarb said.
To negotiate an agreement with more than 100 different organizations would be very difficult logistically without a tool like IntraLinks, he said. IntraLinks gives us an environment where people can form groups and post comments and text. Everybody else can read it, and information doesn'st get lost. Everybody knows where everybody else is coming from, so there are no secrets. At the end of the day, we end up with a document that's very clean and accessible. And because everybody's had a chance to participate in the drafting, there's buy-in.
Drafting the document, Goldfarb said, is the easy part. Adoption is going to be the challenge, so we need an environment where accessing the information and negotiating agreements is easy and secure. IntraLinks is perfect for that.
MAGI also wants to expand its effort internationally. Communicating and negotiating by telephone will be really impractical once we take the effort international, Goldfarb said.
According to Goldfarb, key advantages to the IntraLinks solution are its ease of use and strong technical support. I'sm the administrator and I haven'st read a single a manual page, he said. Anytime I have a problem, I call the 800 number. I'sve talked to a lot of technical support people over the years, considering I spent most of my career in high tech, and IntraLinks has the most spectacular technical support department I'sve ever seen.
Using IntraLinks to facilitate this project brings us closer to a future in which we can negotiate, and even sign clinical study agreements online, Goldfarb said.
IntraLinks is pleased that MAGI has chosen to use its services to enhance the collaboration on this important initiative, Jenkins said. By reducing the time spent tracking paper and exchanging telephone calls, MAGI will significantly minimize the time it takes to bring their efforts to fruition, while experiencing first-hand the value of being part of the clinical community on IntraLinks.
Going beyond contracts, I hope MAGI will encourage the industry to set aside some of its competitiveness and develop other collaborative initiatives to address the serious problems we face. As Ben Franklin said, We must all hang together, or assuredly we shall all hang separately.'s
To learn more about MAGI, visit www.firstclinical.com/magi. To learn more about IntraLinks, visit www.intralinks.com.