Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
It is a tragic truism to remark that the merits of the pharma sector are most sharply perceived only at times of deep human suffering. The debates engendered by the latest Ebola outbreak neatly if nastily demonstrate the point. All of a sudden, the mass media and social networks are reflecting wide public demands for more action on drug development—instead of the customary complaints that drug firms are merely cynical money-making machines. How is it possible—the question is heard over and over again—that in this day and age no vaccines or medicines exist against such terrible diseases? Why have governments been so neglectful of obvious research needs? And as the anger and frustration increase, so yesterday's bad boys in the pharma labs become seen more as the heroes of tomorrow, the great hope for miracle cures, the saviors of the world deserving of munificent funding and strong moral support. It was thus with bird flu, with SARS, and with numerous previous health scares—and once the immediate crisis passed, the abrupt surge of sympathy for drug researchers just as abruptly subsided, and the standard narrative was resumed.
It is a fair bet that over the last week or so the world's mass media have devoted more attention to drug development than they did in the previous year. The challenges facing medical and pharmaceutical research have assumed immediate significance and received front-page coverage. In just a few days, everyone has become an armchair expert on clinical trials, drug pipelines, investigational medicines, and ethics. So while television news bulletins and public prints breathlessly report the latest detail on ZMapp or NewLink Genetics's vaccine or Tekmira's TKM-Ebola, attention is guaranteed.
It is an equally fair bet that within a few weeks, if the outbreak is contained (and for the sake of the victims and potential victims of the disease, it must be hoped that it will), the subject will slip out of the headlines, and the default skepticism—and widespread ignorance—about drug research will reassert itself. What is it about the pharma sector that makes it so vulnerable to the fickleness of public opinion? For decades drug developers have complained that they are unjustifiably misunderstood, and have mounted thousands of campaigns in a bid to explain to an indifferent world why it cannot solve every problem, and that it takes time to get a new medicine from the testbench to the patient. Yet the level of understanding of healthcare and the place of medicines within it is still abysmally low. So each time those who work in drug development try to win a fair hearing for their case, they are obliged to start from scratch, laboring to set out the complexities and difficulties of their work to an audience that is at best dismissive, and at worst downright hostile.
Alongside the real problems facing populations in West Africa, these concerns do not even amount to a sideshow, and quite rightly so. But someday the drug development sector will have to find more effective ways of communicating with the outside world if it is not to remain forever a pariah that intermittently benefits from favorable attention only when some catastrophe makes it briefly fashionable.