Int. J. Environ. Res. Public Health 2009, 6 519 2008, two companies were licensed in California as genetic information services providers, as distinct from medical testing providers, 23andMe and Navigenics [45]. It will be interesting to see whether the traditional medical industry strikes a symbiotic or adversarial stance as additional patient-driven health care models emerge. Regulation could continue to be a bottleneck. Agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are already taxed in responding to the high number of clinical trials and new drug approval requests; in December 2008, the U.S. National Institutes of Health Clinical Trials website listed 65,241 clinical trials in process (http://clinicaltrials.gov) as compared to 48,826 at the start of the year (http://web.archive.org/web/20080102061002/http://clinicaltrials.gov). There could be even more of an effort to organize the process into different tiers with fewer requirements depending on the therapy type. New approval models with peer-based research and support components, analogous to those proposed for patents by Beth Novak (http://www.peertopatent.org) and Lawrence Lessig (http://remix.lessig.org) could be helpful in easing regulatory burdens. 3.6. The Future of Clinical Trials: Vertical and Horizontal Stratification Clinical trials are the biggest cost in the estimated $1.3 billion total cost of bringing each new drug to market [46]. Personalized medicine could trigger the need for more levels and types of cohort testing in both regulatory agency-approved clinical trials and open source patient-run clinical trials. It may make sense to have a wider array of vertical test tiers to accommodate more alternatives to the full-blown clinical trial such as informed patient field studies, small-group phased experiments and data collection projects. Horizontally, there may need to be as many as exponentially more cohort studies to segment varying genetic, phenotypic biomarker and patient history data as the early drugs of personalized medicine, Imatinib and Tamoxifen, are starting to show. The clinical trials process could be expedited dramatically with patient-driven medicine. Health social networks can bring pre-aggregated patient registries and standardized digital data to clinical trial conductors. Health social networks and clinical trial representatives can collaborate in their needs for electronic data collection, ensuring that the quantitative information needed for clinical trials already exists for all participating patients. Clinical trial pre-screening surveys can be administered easily through health social network websites. Related to the quantitative shift in medicine, future drug approvals may require biosimulation modeling and analysis output in addition to live patient data as a standard application component; the use of biosimulation by regulators is already being explored as discussed in Section 2.2.3. Predictive biosimulation. 3.7. Changing Drug Discovery and After-Market Studies The quantitative data repositories of health social networks could become a significant resource in the drug discovery process too as researchers start to be able to cross-reference large databases of genomes, biomarker readings and patient histories. The ongoing self-tracking activities of health social network members might fit nicely with the needs of after-market drug studies. Patients are already logging their experience, adherence and side effects which could then be aggregated to be visible