by Dr. Bill Gluck, Vice-President, Clinical Knowledge
In 2000 a movie entitled ‘Pay it Forward’ was released and it started a social revolution of sorts. Not only has the concept of doing a good deed and asking for nothing in return been popular, it has been a phenomena that has continued for many years. Within our industry, the 'Pay it Forward' concept has taken hold.
Companies within the pharmaceutical, biotechnology, and medical device industries, along with service providers, have embraced the 'Pay it Forward' ideal. I recently read an article about large companies like Pfizer and AstraZeneca and CROs like Quintiles and Parexel and other companies working with a non-profit organization, the Alliance for Clinical Research Excellence and Safety (ACRES) to share technology and services free-of-charge with clinical research sites. The focus of all this cooperation is to streamline and further research to benefit us all.
The ACRES initiative places networking technology at clinical research sites and other key study participants such as IRB's, so all participants can access and share trial information quickly across the network. Through these efforts, Sponsors, sites, IRBs, CROs and regulators can share data, and in real-time, assess feasibility of sites to find patients for clinical trials. They can also assess the availability of well-qualified doctors to act as clinical investigators, thereby streamlining the trial initiation process.
ACRES has also been able to address another need within the industry - the provision of a centralized repository for documents required by FDA and other worldwide regulators regarding investigator qualification documentation¹. Rather than collect these data for each trial conducted from the same investigators, ACRES members will be able to access this data from one place. Member companies in ACRES donate the software and technology needed to make this idea a reality. The efficiencies to be gained using these collaborative efforts are far-reaching. For example, if Investigators need to make an update to any of their documentation, they only need to update the information in one place rather than the various repositories or databases maintained by the various companies they work with. Companies too will be able to maintain closer control and the most up-to-date information on the investigators. How far this level of collaboration can go is yet to be seen.
Other collaborations have also taken hold such as the sharing of clinical data from trials that have not met specific milestones, and by sharing this data; there is the potential that other uses or therapeutic indications might be discovered.
The 'Pay it Forward' concept is not new within our industry. In fact, innovative companies who are focused on delivering meaningful treatment to those in need as quickly and as safely as possible have given their innovative technology, free of charge, to support the development, from the initial concept to the actual cure.
DATATRAK International, Inc., was one of the first companies to provide their EDC application free-of-charge to educational institutions. In 2015 Durham Technical Community College and DATATRAK will celebrate a key milestone of collaboration: Durham Tech in 2000 established one of the first clinical trials research programs awarding a certificate in clinical data management in the country, and in 2005 they worked with DATATRAK to incorporate DATATRAK's commercially available unified EDC application into the teaching curriculum at no cost to the institution. Students have been able to gain hands-on experience and as a result, have an immediate impact on their clinical trials following graduation, safely accelerating the research. Other companies have now followed suit offering their commercial applications to be incorporated into specialized institutional curriculum.
As we are faced with increasingly more difficult health challenges, both locally and worldwide, we will need to rely on collaborations for the greater good and maintain the 'Pay it Forward’ revolution, which all started with a movie.
¹ Barry, Fiona. "Pharma Firms 'saving Billions' in Research – by Giving Away Their Tech." Outsourcing-Pharma.com. N.p., 4 Sept. 2014. Web. 07 Nov. 2014.
For more information on ACRES: www.acresglobal.net/