Opinion in 2013

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.