In the push to accelerate research by shortening clinical trials’ duration, sponsors and sites need to be aware of the risks “fast science” can introduce and focus on trial designs that are proven to maintain scientific integrity while speeding results. Read More
For years, the drug development process has been slow and steady — sometimes painfully so — with a mean timeline of 10 years between a drug’s clinical testing and its approval. Then the COVID-19 pandemic hit and Pfizer received an emergency use authorization for the vaccine less than a year after the virus was identified. Read More
The clinical research industry has made some progress toward improving diversity in clinical research, but the latest U.S. Census still shows minorities are underrepresented in trials. Read More
Most of the general public first heard about research misconduct from hearings on the problem held by then-Rep. Albert Gore Jr. (D-Tenn.), chairman of the Investigations and Oversight Subcommittee of the House Science and Technology Committee, in 1981 Read More
Research misconduct and fraud not only ruin reputations of investigators and institutions but can also damage the public’s trust in clinical research. Consider the case of Piero Anversa, a key figure in stem cell research. Anversa was accused of falsifying or fabricating data in more than 30 research papers. Read More
Having the right resources at the right time is critical to a clinical trial’s success, and no resource is more valuable than a site’s staff. But the uncertainty about future needs caused by the current pandemic makes it difficult to plan for the right staff mix and scheduling. Read More
When preparing a billing plan for a clinical trial, follow the Medicare model to make the best case for reimbursement from other payers, a clinical research compliance expert advises. Read More
When it comes to offering to pay clinical trial subjects to participate, the line between compensation and coercion is difficult to draw but all too easy to cross. Read More
