This week, Clinical Trials Arena will be shining a spotlight on real world data as part of January’s ‘Real World Evidence Week’. Running throughout the week of January 16th, 2017, CTA will post articles uncovering the most pressing issues facing industry today.
Experts, such as, Francois Gavini (Roche, France) explain the need for standardizing evidence generation while Hui Cao (Novartis) provides insight into some of the new trends in pharma non-registration trials, as well as some of their underlying drivers.
But first, be sure to visit CTA tomorrow when Nigel Hughes (Janssen R&D, Belgium) follows up on excellent article with another piece exploring the increasing role of real world evidence in the clinical trials space.
In the meantime, catch up on some CTA’s most recent stories delving into the challenges of real world data... (click on the headline to finish reading)
Elke Bestel, Chief Medical Officer at PregLem, shares some of the best practices for conducting phase IV trials, the benefits of doing so and how to overcome specific challenges of post-clinical testing.
Clinical Trials Arena: What are the benefits of conducting phase IV trials?
Elke Bestel: The majority of post-approval studies we are conducting are mandatory in order to maintain approval, i.e. the so called PASS (Post-Authorisation Safety Study).
Apart from fulfilling the mandatory PASS, some additional benefits come from the marketing side. If you enter the market with a new drug, a phase IV trial will make the drug known and physicians more aware of it. If you do not create awareness, your new drug can be on the market, but the physicians will not think about prescribing it. They have to be aware that there is a new drug with a good safety profile that is possibly more effective than existing drugs available. For example, in phase IV trials, you might have key opinion leaders participating who will know and talk about your drug. They might say they have had a good experience and that their patients are happy with it. Afterwards, these KOLs can talk in congresses about your new drug as good publicity. By having participated in a well-designed trial, all participating physicians will put the drug into the inventory of medications and think about this new drug when prescribing for the respective condition. I think it is worth conducting phase IV studies because you will have more safety and more interesting data that will help you, and physicians, know your product better.
The first controlled clinical trial of the modern era was performed by James Lind in 1747 whilst investigating scurvy in English sailors, but it was the first randomized curative trial, of streptomycin, performed in England in 1946, almost 70 years ago by the Medical Research Council that established the foundation for modern medicine. The pharmaceutical industry has been honing this approach ever since, but in recent times we have seen more scrutiny as to the real world relevance of the randomized clinical trial (RCT).