Now Indian CRO’s Are Getting The Attention Of Regulators

In a follow up to several India clinical trial stories I have covered in the past such as this one regarding the Indian Supreme Court getting more involved in clinical research this year, Indian regulatory agencies are now cracking down on CRO’s which operate in India. According to this report by Fierce CRO, regulatory agenices now make it mandatory for CRO’s to list every clinical trial that they are conducting with the Indian regulatory agencies much as is the requirement in the United States with India has undergone much public scrutiny these past few years for perhaps putting ethical considerations for human subjects on the backburner in exchange for an exponential growth rate in the clinical research industry infrastructure and ecosystem. As I have commented on before, India was once a hotbed and outsourcing destination for US and European Pharma companies due to the much cheaper cost of conducting clinical trials combined with the world’s second largets population and overwhelming number of research naive study participants. These recent developments in the Indian regulatory system as they pertain to the conduct of clinical trials in India may be paving the way for China to become the latest outsourcing destination of choice for US and European drugmakers. As always, I will keep a close eye on this developing story and report as more information becomes available.

Clinical Trials And I.T., Dont Get Left Behind! An Interview With BioPharm Systems

Today’s Guest Guru is Adrian Hampshire, Managing Director EMEA for BioPharm Systems. BioPharm Systems plays an important role in Information Technology and clinical trials by assisting Pharma companies, biotechs, cro’s, academic institutions and the like solve their data analysis problems and much more. In this interview Adrian and I discuss what BioPharm Systems does and also what some trends are for the future of IT and clinical trials. Some of the highlights of the trends are Efficiency of execution, Maximizing value of data, and Ease and efficiency in accessing solutions in the cloud. I think it is extremely imprtant for us in the industry to understand the implications of technology and how it has already impacted and will continue to impact research such as in adaptive trials which I covered earlier here. As always, feel free to share your comments below!

How Off-Labeling Pharma Marketing Can Actually Help Clinical Trials!

Today’s video is with regular guest and Clinical Trials Guru Producer Darshan Kulkarni of Kulkarni Law Firm. Darshan came on today to discuss the recent buzz in the pharmaceutical industry regarding off-label marketing and how Pharma may actually be allowed to promote their products for off-label (not FDA approved) use as long as there is enough research to support their claims. This may be a game-changer for us in the clinical trial community and Darshan and I discuss how this will most likely impact clinical trials in general. Let me know as always what your thoughts are on this developing story!

IRB Guidance On Social Media In Clinical Trials Is Overrated!

So Quorum IRB recently released an article which gives some guidance on the use of social media when it comes to clinical research. Due to the fact that the FDA has not released any helpful guidance on this topic, I welcome Quorum’s efforts to clarify the proper use of social media in clinical trials but I think this is all overrated. When it comes to clinical trial recruitment, the initial contact between research site and study participant usually does not involve ANY study-specific content unlesss it’s a traditional advertisement, in which case, social media would not be the ideal platform to distribute this content. Social media works because it does not function off of ads, it functions off of real content that actually produces helpful information for the recipients of the content. Furthermore, it may allow for further communication between the two parties in which case, the clinical research sites can schedule an actual pre-screening visit with the study participant. I argue that the best way research clinics or CRO’s can reach potential study participants is by actually demystifying clinical trials rather than jumping right in to study specific details. The best ways to do this are to promote the types of trials they do and focus on content around those medical conditions, while leaving the study specific details for future contacts between a member of the study staff and the study participant. Let me know your thoughts on this.

The Twelve Days of Research Christmas-By Guest Guru Stacey Carmody

5-12-13The Twelve Days of Research Christmas
On the 12th Day of Christmas, research gave to me:

12 subjects screening
11 stipends paying
10 monitors visiting
9 samples shipping
8 people consenting
7 staff-a- meeting
6 queries posting
5 G..C…P…’s!
4 IRBs
3 Protocols
2 PI’s
And a coordinator who is goin’ craaz-y!
-Stacey Carmody

Clinical Trials In Russia Including Corruption and More Part 2

In this second part to our discussion on clinical trials in Russia, we discuss a few interesting differences between trials in the United States as Russia such as a significant amount of government corruption, the lack of study coordinators, and the centralization of most study vendors when it comes to specific protocols. I interviewed Anton Akulov, a Russian psychiatrist who currently works as a sub-investigator for my company in the United States and I hope you find this discussion interesting. We also discussed by the way, the fact that in Russia, most clinical trial participants are not compensated for their time in the studies like they are in the States. For you Russians out there as an added bonus, check out Anton’s shoutout to you guys in Russian towards the end of the video.