Exploring the Engagement of Racial and Ethnic Minorities in HIV Treatment and Vaccine Clinical Trials: A Scoping Review of Literature and Implications for Future Research.

HIV disproportionately impacts US racial and ethnic minorities but they participate in treatment and vaccine clinical trials at a lower rate than whites. To summarize barriers and facilitators to this participation we conducted a scoping review of the literature guided by the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines. Studies published from January 2007 and September 2019 were reviewed. Thirty-one articles were identified from an initial pool of 325 records using three coders. All records were then assessed for barriers and facilitators and summarized. Results indicate that while racial and ethnic minority participation in these trials has increased over the past 10 years, rates still do not proportionately reflect their burden of HIV infection. While many of the barriers mirror those found in other disease clinical trials (e.g., cancer), HIV stigma is a unique and important barrier to participating in HIV clinical trials. Recommendations to improve recruitment and retention of racial and ethnic minorities include training health care providers on the importance of recruiting diverse participants, creating interdisciplinary research teams that better represent who is being recruited, and providing culturally competent trial designs. Despite the knowledge of how to better recruit racial and ethnic minorities, few interventions have been documented using these strategies. Based on the findings of this review, we recommend that future clinical trials engage community stakeholders in all stages of the research process through community-based participatory research approaches and promote culturally and linguistically appropriate recruitment and retention strategies for marginalized populations overly impacted by HIV.

Promoting healthcare innovation on the demand side.

Innovation policy often focuses on fortifying the incentives of firms that develop and sell new products by offering them lucrative rights to exclude competitors from the market. Regulators also rely on these same firms-and on similar incentives-to develop information about the effects of their products in patients, despite their obvious conflict of interest. The result may be a distorted understanding that leads to overuse of expensive new medical technologies. Recent technological advances have put healthcare payers in an excellent position to play a larger role in future innovation to improve healthcare and reduce its costs. Insurance companies and integrated healthcare providers have custody of treasure troves of data about healthcare provision and outcomes that can yield valuable insights about the effects of medical treatment without the need to conduct costly clinical trials. Some integrated healthcare systems have seized upon this advantage to make notable discoveries about the effects of particular products that have changed the standard of care. Moreover, to the extent that healthcare payers can profit from reducing costs, they will seek to avoid inappropriate use of costly technologies. Greater involvement of payers in healthcare innovation thus offers a potential counterweight to the incentives of product sellers to promote excessive use of costly new products. In recent years, the federal government has sought to promote innovation through analysis of healthcare records in a series of initiatives; some picture insurers as passive data repositories, while others provide opportunities for insurers to take a more active role in innovation. In this paper, we examine the role of health insurers in developing new knowledge about the provision and effects of healthcare-what we call 'demand-side innovation'. We address the contours of this underexplored area of innovation and describe the behavior of participating firms. We examine the effects of current legal rules on demand-side innovation, including insurance regulation, intellectual property rules, privacy protections, and FDA regulation of new healthcare technologies. Throughout, we highlight many policy tools that government can use and is using to facilitate payer innovation outside the traditional toolkit of patents and exclusive rights.

Adjuvant Gamma Knife radiosurgery following surgical resection of brain metastases: a 9-year retrospective cohort study.

Given the potential morbidity of whole brain radiation therapy (WBRT), there has been an increasing trend to defer WBRT and deliver Gamma Knife stereotactic radiosurgery (GKS) to cerebral metastatic lesions. We analyzed our experience delivering GKS to the tumor cavity following surgical resection of brain metastases and compared our results to patients receiving WBRT after surgical resection of a metastatic lesion. We performed a retrospective review of patients undergoing surgical resection of at least one brain metastasis between December 1999 and December 2008. Both univariate and multivariate Cox proportional hazards regression were utilized to analyze the influence of various prognostic factors on survival. Twenty-five patients had a metastatic lesion resected followed by adjuvant GKS to the resection cavity while another 18 had surgical resection followed by WBRT. Aside from a disparity in gender distribution (72% of GKS patients were female while women only constituted 28% of the WBRT group), no significant differences existed between groups. The median survival for patients receiving GKS was 15.00 months as compared to 6.81 months among those receiving WBRT (P = 0.08). Univariate Cox regression analysis identified the number of metastases (HR 1.65, 95% CI 1.07-2.54, P = 0.02) and regional recurrence (RR 5.23, 95% CI 1.78-15.38, P = 0.003) as poor prognostic factors. Multivariate regression analysis showed that regional recurrence (HR 5.17, 95% CI 1.69-15.78, P = 0.004) was again strongly associated with worse survival. Although limited by the retrospective nature of our study and lack of some clinical measures, patients undergoing GKS to the resection cavity had a trend towards longer median survival.

Reaching through the genome.

Advances in genomics research have called forth new strategies for patenting DNA sequences. Gene patenting, which began inconspicuously in the early days of the biotechnology industry in the 1970s and 1980s, did not generate significant public controversy until the advent of high-throughput DNA sequencing in the 1990s. By this point, it was such a well-established practice that categorical challenges to the patentability of DNA seemed quaint and out of touch. Yet something was plainly different. In the early days, patenting genes looked like patenting drugs. By the early 1990s, it looked more like patenting scientific information. We have a reasonably clear story about why we should issue patents on drugs; the case for issuing patents on scientific information is less clear. Patents on research discoveries arising far upstream from end-product development threaten the interests of research scientists, who fear impediments to the free use and dissemination of new discoveries, and of downstream product developers, who fear that they will be foreclosed from pursuing certain research and development (R&D) pathways or that their profits will be diluted by the claims of upstream predecessors. At the same time, it is not obvious how upstream patent owners might use patents to capture the value that their discoveries contribute to downstream product development, particularly in the face of concerted resistance to sharing the wealth. This strategic challenge is leading upstream innovators to pursue novel patent claiming and licensing approaches that raise unresolved doctrinal and policy questions.

Patenting genome research tools and the law.

Patenting genes encoding therapeutic proteins was relatively uncontroversial in the early days of biotechnology. Controversy arose in the era of high-throughput DNA sequencing, when gene patents started to look less like patents on drugs and more like patents on scientific information. Evolving scientific and business strategies for exploiting genomic information raised concerns that patents might slow subsequent research. The trend towards stricter enforcement of the utility and disclosure requirements by the patent offices should help clarify the current confusion.

Public vs. proprietary science: a fruitful tension?

The authors examine the presumption that basic scientific research is most effectively utilized when the findings of that research are openly disseminated without significant restriction, while research with more practical application should be the prerogative of private enterprise. However, many fields, including molecular biology generally and genomics in particular, lie in the intersection between basic research and application. Moreover, institutional boundaries that once reasonably sharply demarcated basic research from technological development have grown porous, with more academic research finding application in industry. The authors consider the Human Genome Project and rival industry sequencing efforts as a case in point of the new political economy of scientific research. Since the inception of the Human Genome Project, there has been general agreement among researchers that the project would be most advantageous to science if the sequence data were made publicly available, quickly and without restriction. Many of these arrangements required federal agencies and some universities to "maneuver around" the Bayh-Dole Act. In several cases, most notably genomic sequences and the SNPs (i.e., single nucleotide polymorphisms) consortium, it was the pharmaceutical industry that initiated or helped enable the project to ensure open and unencumbered access to information, the type of access that has historically been the provenance of academia and the raison d'être of academic research. The authors conclude by reasserting the value of public science as a broadly valuable and enabling social commitment, not limited simply to the products or technologies it spawns.

How can you patent genes?

What accounts for the continued lack of clarity over the legal procedures for the patenting of DNA sequences? The patenting system was built for a "bricks-and-mortar" world rather than an information economy. The fact that genes are both material molecules and informational systems helps explain the difficulty that the patent system is going to continue to have.