The need for innovation in biomanufacturing

489 immediately on the welfare of subjects and the interpretability of trials. Moreover, these studies have a structure similar to controlled clinical trials and are unlike basic science (which has a more exploratory structure). Third is the question of cost. Registries entail administrative costs (the 2007 budget for clinicaltrials.gov (http://clinicaltrials.gov/) was $3 million) and compliance expense for investigators. Well-documented flaws in reporting and compliance with trial registries would likely be recapitulated in preclinical registries10. Would benefits outweigh costs? Without a proper cost-benefit analysis or a specified registry architecture, we cannot provide an unequivocal answer. We do not underestimate the technical, economic, political and logistical challenges of incentivizing good preclinical disclosure. Nevertheless, models less costly than clinicaltrials.gov might be explored, such as those used to promote deposition of genomic and microarray data. High-impact biomedical journals, for example, might encourage good disclosure practices by requiring authors of trials or preclinical experiments to include a sentence stating that complete summary preclinical evidence has been deposited in a public database. Funding agencies might consider mechanisms, like those used for prospective protocol review in gene transfer trials, to encourage researchers at publicly funded institutions to deposit supporting preclinical evidence. Trial registries began with a series of modest steps that afforded opportunities to test and refine models. Initially, registries incorporated only publicly sponsored studies. Research agencies and drug regulators then convened working groups to establish data elements for inclusion. Only later did journals and legislation establish rules that significantly incentivized good disclosure practice11. Implementation of preclinical registries should follow a similar course of iterative refinement. In recent years, various funding bodies have signaled their commitment to clinical translation by creating new support and mechanisms for research. To better meet the potential of these programs while enhancing protections for volunteers, we urge funding agencies, journals, foundations and academic institutions to devise policies that promote registration and reporting of preclinical results.