CRO Founded to Address Neglected Diseases in Under Served Countries

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-04-01-2012, Volume 21, Issue 4

PHACT is making inroads in drug development for neglected disease.

Founded almost one year ago, the non-profit CRO, Public Health Alliance for Clinical Trials, or PHACT, is making inroads in drug development for neglected disease. Ellen Morgan, former Co-Founder, President, and CEO of CRO Synteract, launched the CRO with the intention of building operations in areas where the need exists but CRO infrastructure is lacking. The goal of the CRO is to support non-profit product development partners (PDPs) and pharmaceutical companies with trials in diseases such as malaria, cholera, dengue fever, tuberculosis, parasitic diseases, as well as women's health issues.

Morgan noted in an interview with Applied Clinical Trials that PHACT wants to be able to conduct these trials in a very cost-effective way so that their clients—generally nonprofit companies themselves—can conduct more trials at a lower cost. The company intends to reach its goals with a blend of technology, targeted location capabilities, local training, and functional management.

Ellen Morgan launched PHACT to help develop drugs for neglected diseases.

Said Morgan, "We use a very strong functional management team here in the United States and have trainers that will work with people in the underdeveloped countries, such as Ghana and Bangladesh, and train people there. The majority of the work, including site monitoring, data management, and statistical programming will be done at the local country level where salaries are much lower. Also, we won't be flying CRAs from Europe or from the United States. Most of the monitoring will be done by people who are a resident in those countries."

The technology aspects that PHACT is using include an EDC system or electronic source record system that can be used offline where the data can be submitted to the central data repository at a later time when an Internet connection is available.

"With the use of these systems, the CRA can then review the data remotely and do a lot of work before they actually make their monitoring visit. And this can cut down on the number of monitoring visits required," explained Morgan. In addition, they use video informed consent as a way to clearly and ethically communicate the trial protocol so that potential participants can understand.

Utilizing its strong functional management in the United States, the organization is training to build local know-how in clinical trials, which helps local economies in these countries. As Morgan said, "It's important to teach the sites, study monitors, and other clinical personnel—teach them about clinical trials so that once a study is completed, they have something that they can use in the future. They will have some skills to use in the future. And we may also help in building local ethics committees if that's required."

Initially, the organization will collaborate with fellow CROs in other developing countries as appropriate; future plans are to establish offices throughout Sub-Saharan Africa, India, and other parts of Asia.

PHACT Co-Founders Christian Sacher of Germany, and Yaw Asare-Aboagye, a native of Ghana, have strong backgrounds in the healthcare industry. Sacher is Founder and CEO of the CRO Verum with headquarters in Munich, Germany and offices in Eastern Europe and Asia. He has pioneered clinical trials in Romania, Ukraine, and Pakistan.

Asare-Aboagye has more than 20 years of clinical trial experience in the United States, having worked for both large and small pharmaceutical and biotechnology companies, overseeing clinical research and data management functions. A native of Ghana, Asare-Aboagye holds a DVM degree and a Master of Science in biostatistics. He has been an advocate for clinical trials in developing countries for decades and is a regular speaker on the conduct of clinical trials in Africa at the African Partners Medical conference held in Ghana annually.

In addition, the Director of PHACT, Chris Hentschel, PhD, is a founding former CEO and Board Member of Medicines for Malaria Venture (Geneva) and of the MRC Collaborative Center (London), says, "Having been involved in neglected disease research for more than a decade, I have often felt the need for a CRO that espoused the beliefs and values we see in this new initiative. PHACT is truly unique at this point and will help move the field to the next level."

Editor's Note: A podcast interview with Ellen Morgan is available at http://bit.ly/w60UAo.