Modern biomedical innovation and the discovery of new cures and therapies for devastating diseases require robust collaboration and coordination among industry, research institutions and physicians. By bringing together the brightest minds in medical research, our nation’s research enterprise has successfully brought hundreds of new drugs, biologics, and vaccines to market in recent years and developed a wealth of clinical prescribing information. Ongoing research is advancing the fight against some of humanity’s worst scourges, such as HIV/AIDS, Alzheimer’s, cancer, Parkinson’s, and multiple sclerosis. Yet some observers have argued these relationships result in harm to patient care and diminished research integrity. This couldn’t be farther from the truth. At BIO, we, along with our member companies, adhere to high ethical standards including guiding principles regarding potential conflict of interest issues.
We recognize that the potential for conflicts of interest often exists, and that any such conflicts should be addressed and appropriately disclosed. However, it is important to note that close relationships between industry and researchers have had a beneficial impact on research and patient care. Many of the relationships that create concern among industry watchdogs have, in fact, proven enormously valuable to the general public. Academia and industry enter into research agreements for the purpose of advancing research that often results in new drugs for patients. They can also fuel economic development in states or regions, and create new opportunities for research or supplement existing research budgets.
Critics of the very idea of collaborations between biopharmaceutical companies and medical researchers incorrectly assume that financial relationships automatically bias the conclusions of the researchers . This misperception does a great disservice to the dedicated men and women at the front lines of our nation’s fight against disease. These scientists should be credited for engaging in innovative partnerships between academia, industry, and government to advance our understanding of disease and to evaluate the benefits and risks associated with various medical interventions. In many instances, the pool of experts in a given field can be quite small, particularly for cutting edge technologies and rare diseases. To disqualify the scientific views of investigators who collaborate with both the private and public sector ultimately undermines our nation’s ability to discover and deliver new modern medicines to patients.
Furthermore, critics of industry funding sometimes ignore the possibility that other sources might have the potential to bias research. Because the research ecosystem involves numerous stakeholders working together, the recognition and management of conflicts of interest is a jointly held responsibility among numerous partners: industry, government, academia, professional organizations, journals and the media, and individual researchers.
BIO and its member companies are also committed to helping assure that patients and healthcare providers have access to key clinical trial results information. We believe that individual patients, clinical decision makers and scientific researchers should be armed with accurate, scientific evidence to help assess the relative clinical benefits and risks of various treatment alternatives. It is critical, however, that information subject to dissemination meet established scientific standards and do not undermine the ability of our member companies to conduct research into new treatments that will help patients in the future, for example, by releasing information that undermines a company’s competitive position and ability to raise capital to fund its research.
BIO was pleased to participate in the public rule-making process to expand the www.clinicaltrials.gov registry and results database and we are looking forward to NIH publication of the draft regulation detailing the next steps in the expansion process. In addition to the legal requirement that the results of clinical studies for approved products be posted in the database, BIO has also recommended to NIH that the results from pivotal confirmatory clinical trials for unapproved products be submitted once a product has been discontinued in development for all indications, when such trials were terminated due to safety reasons.
BIO supports policies that protect patient care and research integrity, as well as promote productive relationships between industry and researchers and the responsible disclosure of clinical trial results. To learn more about BIO’s decision-making framework regarding conflict of interest issues, please read here. To learn more on BIO’s position on clinical trial results disclosure, please read here.