Trial Site Selection

New patient recruitment avenues in clinical trial site selection process: online social networks

Brian Loew, the CEO of Inspire, one of many online social networking sites that bring groups of people together who suffer from the same disease or condition, reports that, “You can’t create a community just about clinical trials.” He says that social networking functions as “a mechanism for attachment.” His company collaborates with many non-profit health organizations and screens the list of members who have volunteered to be trial participants using each trial's inclusion and exclusion criteria.
 
“For one of the [lung cancer] studies, we already have a community with ten times the number of members who meet the initial inclusion criteria,” says Loew. An additional service provided is quality assurance in which data is collected from participants about their degree of satisfaction with the trial and compiled into a report.

PatientsLikeMe initiated the first “patient-driven, real-world natural experiment” in which large amounts of data was collected in a few months at very little cost. These online studies can provide “credible direction as to when a clinical trial should be conducted. As a result, patients will have a direct voice into what types of research deserve attention and significant investment" in the resulting clinical trials, according to president and co-founder Ben Heywood.

Best-in-Class Trial Site Selection Providers:

• A proven track record of efficient randomized patient enrollment
• The ability to get up and running quickly and to generate timely, high quality data and reports
• Can handle the pharmacokinetics/ pharmacodynamic and other laboratory or radiological studies that support the trial

Top Considerations Before Selecting Trial Site Selection Providers:
Clinical trials represent about 30% of companies’ drug development budgets. Due in part to slow patient recruitment and poor retention of trial participants, 75% of trials fall behind schedule, increasing costs. Online social network recruitment may be able to rapidly deliver a larger and more dedicated population. Ask whether the providers you are considering have considered this method.

Key Providers:

1. Rules-Based Medicine, Inc. (RBM), is a trial site provider. RBM, founded in 1998, is the world's leading biomarker testing laboratory. By combining EDI’s cell culture systems with its HumanMAP® biomarker testing services, RBM is able to offer customers a preview of the physiological and biochemical impact of a new drug before the human trial stage begins. RBM has corporate headquarters and CLIA-certified biomarker testing laboratory in Austin, TX; multiplex assay development and manufacturing in Lake Placid, NY and a wholly owned subsidiary EDI GmbH in Reutlingen, Germany. Through EDI GmbH, RBM provides Human Organo-Typic (HOT) cell culture systems which serve as a platform for ex vivo drug safety and efficacy studies.

3. The Jackson Laboratory is a trial site provider whose services include testing numerous medicinal entities, including small molecules, antibodies, siRNAs and ES cell-derived therapies, as well as customizable compound evaluation, phenotyping and pathology services. This company is an NCI-designated Cancer Center that uses mouse genomics to discover ways to prevent cancer as well as to discover drugs to treat conditions including: cancer, diabetes, Alzheimer’ and cardiovascular disease. In addition to conducting genetic research, this independent, nonprofit organization provides scientific resources, techniques, software, data and mice colonies for test animals to scientists in research institutions and laboratories around the world. Jackson Laboratory scientists are engaged in collaborative research with organizations around the world. 

4. ASKA Research offers a full range of clinical trial monitoring services from project conception to final approval, including Project Management which involves managing all aspects of the trial like site selection and ICF and CRF design. Customers include pharmaceutical, biotechnology and biologics companies, in addition to research organizations that receive federal funds. ASKA reports that "Through one point of contact, you have access to our Research Professionals Network (RPN) of established clinical research professionals, our collaborative partner organizations, and our CRO alliance partners in the United States, Europe and the Asia-Pacific region."

5. Global Research Services offers consulting services for clinical trials including Strategies for Accelerating Patient Recruitment which involve its proprietary tools. GRS has access to global patient populations through offices in Rockville, MD; Langenfeld, Germany; Warsaw, Poland; Montreal, Canada; Shanghai, China; Maharashtra India; Rosario, Argentina; and Sao Paulo, Brazil. GRS utilizes all electronic start-up processes, plans and tools including established start up plans, document templates and comprehensive checklists and has international regulatory experience. This private company has over 20 years of experience.

Trial Site Selection
Definition: The series of considerations that go into choosing which company will conduct a clinical trial.