Teams have a variety of options when conducting a post-marketing study, and these options only increase as researchers continue to innovate new trial designs beyond the standard randomized controlled trial (RCT). For instance, teams may decide to collect real-world data with observational cohort studies. Others may want to directly compare two competing treatments with crossover studies. Alternatively, study teams may try to collect near real-world data with pragmatic RCTs.
Benefit-risk analyses help life science teams compare identified safety concerns with product efficacy outcomes. Often, life science teams begin constructing risk-benefit profiles while products are in the preclinical or early clinical development stages. After establishing their initial profiles, teams will update risk-benefit information as new data becomes available. Much like patients’ medical records, products’ benefit-risk profiles remain associated with them for life. Continue reading
Schizophrenia is a complex psychological disease state that distorts patients’ cognitive and emotional responses. Patients may experience positive symptoms such as delusions, hallucinations or disorganized thought patterns. Patients may also exhibit negative symptoms like those typically associated with depression; things like lack of pleasure in everyday life and lessened emotional range. The World Health Organization estimates that schizophrenia affects up to 24 million individuals globally. In the US, an estimated 1% of the adult population — 2.4 million — have schizophrenia. Continue reading
As the old saying goes, “Good help is hard to find.” Well, sometimes the best option is to make it easier for the help to find you. Our research has shown that Investigator-Initiated Trial proposals are on the rise over the last three years — averaging 173.3 per company in 2011, up 23 percent from 141.2 in 2009. In talking with IIT executives, many of them experienced noticeable increases in IIT proposals when their online submission portals were up and running. Continue reading
Phase 4 clinical trials not only serve to gather valuable data surrounding drugs’ safety, tolerability and real-time effectiveness, but also to test potential new indications, develop stronger marketing profiles, gain payers’ favor and prove superiority over competitors’ products. While many phase 4 trials are conducted at the requirement of regulatory agencies, many are conducted simply to help boost products’ profiles. Needless to say, these trials can be particularly pertinent to the success, or failure, of a product regardless of the reason. Continue reading
The Office of the Inspector General at Health and Human Services (OIG) has been highly focused recently on tracking and publicizing pharmaceutical companies’ payments to thought leader physicians and clinical investigators. A number of companies have found themselves under investigation, and some have had to enter into Corporate Integrity Agreements to ensure their practices are up to the scrutiny.
Teams that run investigator-initiated trials (IITs) can play a major part in avoiding (or passing) OIG scrutiny by focusing on improvements in three major areas: Continue reading
Post-marketing research is a growth area. An ever more cautious and stringent regulatory environment, payers that require more and more data to justify formulary approval and reimbursement, and more crowded markets mean that Phase 4 research is a requirement in practical terms for many products when they launch into the market. Continue reading
Pharmaceutical companies are growing more strategic in their investigator initiated trial (IIT) selection. As Research and Development organizations have sharpened their focus on mission-critical pre-approval clinical development studies, external investigators have become a critical channel to answer post-marketing product profile questions. But even as clinical resources concentrate on earlier phase work, IIT proposals do not organize, review, approve and manage themselves. Continue reading
Our current review of pharmaceutical and biotechnology strategy for the new year finds that 42 percent of companies will see investigator initiated trial budgets increasing in 2012. Companies fund investigator initiate trials (IITs) to support additional clinical testing of post-marketed products conducted by independent physicians, often on smaller patient populations than those required by regulatory agencies for drug approval. Continue reading
Over Half of Drug Companies Now Use Electronic or Web-Based Tools for Managing Proposals
Electronic or web-based submission systems for investigator initiated trial (IIT) proposals are now in place at 58% of biopharmaceutical companies, and that number is expected to grow. Three-quarters of large, top 25 drug companies have electronic systems in place, compared to only 40% of the remaining top 50 companies. The early adoption of these online Investigator Initiated Trial submission systems by large companies is primarily due Continue reading