Opinion

As drug prices have increased, there is also greater pressure to find ways to ensure access to medicines. An existing provision of the Bayh-Dole Act could help to lower costs for qualifying drugs in federal programs such as Medicare and Medicaid.

In the digital age, biomedical scientists are frequently contacted by lay individuals seeking medical help, but they still receive little, if any, training in how to respond. Researchers need to reach back to these patients, but in a way that steers clear of giving medical advice.

The Canadian Institutes of Health Research (CIHR) recently terminated its MD/PhD training program without clear alternative funding in place. This misguided decision must urgently be reversed, as it has the potential to diminish a unique pool of graduates at the forefront of translational research.

The pharmaceutical industry has recently taken steps to make clinical trial data more accessible. But for there to be meaningful transparency, governments—not drug companies—should set the terms of disclosure.

The mentorship of early-career scientists is necessary to their individual career success and the future of the biomedical research enterprise as a whole. Recently launched NIH programs and tools aim to facilitate this important type of training.

A growing number of participants in clinical trials are sharing information about their health online. It's time that the drug development community starts to examine how this social media use might compromise the integrity of research studies and how it might also offer new opportunities.

The European Medicines Agency requires that drug developers submit a 'pediatric investigational plan' to ensure that there is adequate information about how children fare on experimental medication for many indications before they go to market. But this requirement places an undue constraint on the makers of new hemophilia drugs and threatens to create an unreasonable delay in access to these therapies among adults with this disorder in the EU.

The problem of inequity in international research is perpetuated by policies that enable scientists to conduct research in lower-resourced areas of the world without partnering with local researchers. The World Health Organization (WHO) needs to lead in solving this problem by working with research institutions, journal editors and funding agencies to document the degree of inequity and to impose penalties for failures to collaborate.

Enabling women to serve at the highest leadership levels in pharmaceutical R&D will help advance science to offer a broader array of medicines to patients. But in an industry dominated by men in the most senior-level roles, women have a long way to go to get to the top.

Better outcomes and lower costs are needed in cancer care. To establish true value for money, researchers must establish what matters most to patients and other relevant stakeholders—including families, employers and even insurance companies.

Drug development depends on preclinical experimentation in animal models. To make the public aware of the vital role of these studies, pharmaceutical companies should be legally obliged to make note of this on their products that came to fruition through animal research.

There is no rulebook for how to be a scientist−advocate, but that shouldn't stop researchers from engaging with the broader community. In fact, it's an essential part of being a good steward of your science.

Doctors often dismiss drugs as ineffective if they fail to outperform dummy pills in randomized trials. That's a mistake. When active medicines have few side effects and produce a strong placebo effect, such drugs, even if they prove just slightly better than placebo, should be embraced for the relief they can bring to patients who have few safe alternatives.

Most research prizes in biomedicine, from the Nobels to the Laskers, are restricted to three recipients. But in an age of big science, when much larger teams are generally needed to make important research discoveries, all the people who provide seminal contributions deserve to be awarded.

Almost 50 years ago, the World Medical Association adopted the Declaration of Helsinki as an ethical guide for research involving human subjects. There are now proposed revisions under consideration that will provide additional protection for study participants as well as increased clarity regarding the responsibilities of those conducting the research. Making these changes is important in a complex environment where what is ethical is not always self-evident.

Genomic advances, including next-generation sequencing, offer substantial opportunities and challenges for stratified and personalized medicines. However, the lack of standardization in genomic diagnostics translates into a major risk of error introduction. To ensure the integrity of such data—and their application—we suggest the development of 'good genomic practice' standards to guide the field.

After years of decline in the public eye, drug companies should implment a bioethics accreditation or rating program to help appropriately restore the industry's good name and improve its effectiveness in advancing global health and new treatments.

It's up to stakeholders at every stage of therapeutic development—industry and academic researchers, policymakers, patient foundations and even patients themselves—to embrace the power of collaboration. Only then will we enable translational research and push much-needed treatments to the clinic faster.

India has become a hotbed of clinical trials, but recent reports of safety lapses have prompted calls for better regulation in this area. Currently, trial requirements can be relaxed if doing so is in the 'public interest', but a clearer definition of what this means is needed before this provision should be used.

In recent years, the pharmaceutical industry has struggled to deliver new therapies, especially for diseases that affect the most vulnerable in developing countries. The global health community can fill this vacuum by catalyzing innovative partnerships across academia, government and the private sector, fostering a more rigorous environment for scientific decision making and creating the tools and infrastructure to conduct effective translational research.