Clinical trials are fundamental to testing new medicine, investigating existing medicine and improving healthcare. Most research protocols are either designed by researchers employed by the pharmaceutical/ medical device company or investigators from academic institutions. Here are six things that distinguish industry clinical trials from academic clinical trials:
Funding ? Industry-initiated clinical trials are financially supported by the industry. The primary investigator (PI) salary and the costs associated with running the trial are all covered by the pharmaceutical or medical device company that created the clinical trial. In academia however, the PI applies for program and government grants to fund their research.
Trial type ? Academic institutions tend to pursue comparative studies where the investigators are either comparing one intervention to another, comparing a medley of interventions or comparing a pharmaceutical intervention to a non-pharmaceutical intervention. On the other hand, industry led clinical trials are often researching efficacy of a new drug or medical product.
Motivations ? Ultimately, both industry-initiated and academic clinical trials strive to improve healthcare. However, they have individual motivators for pursuing clinical research projects. In order to market a new product and generate profit for the company, industry needs clinical trials to provide evidence for success of a new drug or medical device. Whereas in academia, researchers are motivated by potential academic and medical impact. Success and career progression is measured by the impact of their scientific contribution and number of publications researchers produce.
Timelines ? Because drug development takes years, industry is often under strict timelines for the launch of the new product. This is especially true when a patent for new investigational product is involved. The sooner the company can profit from a patent-protected product, the better it is for the company. Similarly, pharmaceutical & medical corporations serve shareholders, who want to see profitability and quick turn around times. In academia, researchers don?t answer to shareholders and can take time with their study design and execution.
Investigators ? The industry often enlists contract research organizations (CROs) to run their clinical trials. The CROs are then responsible for finding primary investigators, sites for running the clinical trials and the overall clinical trial management. Conversely, at academic institutions, the PI is responsible for running their own clinical trials and for finding partners at different locations to test their intervention.
Ownership/ Intellectual Property ? Intellectual property belongs to whomever designed the research protocol. Since industry-initiated studies are designed by the industry, they own the rights to the investigational product being researched, the clinical data and the publication rights. In academia, the research protocol is designed by the PI conducting the research, and therefore the PI has ownership over the intellectual property rights (i.e. if a new intervention is being investigated), the data and the publication rights.
At Bay Area Research Logistics we work with industry, CROs and academic partners to help facilitate clinical trial logistics. We have helped our partners develop and coordinate all phases of clinical trials. Visit our services pages to learn more about how we can help you with your clinical trial logistics or contact us directly to chat with a representative about your unique clinical trial needs!