Conducting Clinical Trials Faster And Cheaper In India

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It might take somewhere between 10 and 15 years for the drug development process to proceed from pre-clinical trials to completed phase III clinical trials. From these aforementioned trials, the phase II and III clinical trials account for almost 50 percent of the time and resources of the combined pool of studies. Given this situation, it looks imperative that pharmaceutical and biotechnology companies ought to look for ways to conduct trials faster and cheaper. Unfortunately, most clinical trials still take far too long and cost way too much.

The reasons for this have been the dropping enrollment rates for clinical trials in the US and Western Europe and that has led pharmaceutical companies to think of alternative strategies and choose more exotic locations where they can have trial sites with research naive study participants and hopefully enroll more volunteers in order to complete these trials at faster rates while spending less money to do so. India very quickly became one of these “exotic” destinations for pharmaceutical companies and CRO’s to outsource their trials to. The reasons for India being the premiere destination for outsourced clinical trials will be analyzed below.

A vast, unwieldy population, a plethora of diseases, and rampant poverty: this was the picture India presented to the outside world until only very recently. But these days the fact that India has the largest pool of patients suffering from cancer, diabetes and other maladies has given India a new moniker: the global hub of outsourced clinical trials.

It is believed that one of the advantages of conducting clinical trials in areas such as Eastern Europe and Asia is the speed at which patients can be recruited; as it is very difficult to get research naive patients to enroll in trials in the United States. Enrollment rates in the Far East and China and Eastern Europe and India are much faster. So, if a drug company needed 200 patients for an oncology trial, its chance of getting them in India within a three-month enrollment period is much higher, whereas it might take them a year or more in the US.

India has capitalized on the potential for clinical research and is building up its capabilities by attracting various international and domestic pharmaceutical companies. Apart from taking these initiatives, India offers advantages such as a highly diverse population, well-equipped hospitals, English speaking doctors, government initiatives and increased awareness among various healthcare professionals regarding ICH-GCP guidelines, and finally, cost effectiveness, thus creating its potential to become a major clinical research destination for years to come. Notice however that we did indeed say potential, as we cover certain key obstacles that may push drugmakers to begin outsourcing their trials in places other than India. First, lets focus on some of the catalysts of clinical research in India.

Indian regulatory authorities have been working towards updating their existing guidelines for some time. This has resulted in the existing Drugs and Cosmetic Act and Rules, Indian GCP and ICH GCP guidelines. The efforts have helped streamline guidelines in India and put them on par with international standards. This confirms the commitment towards improving the quality of data generated as well as strengthening compliance to the rules and regulations for the benefit of the industry.

Some of the new guidance documents include registration of clinical trials, guidance on clinical trial inspection and draft rules for CRO (Clinical Research Organization) registration, among others. These will assist in ensuring the validity, reliability and accountability of the trials carried out in India. Moreover, many clinical studies, including bioequivalence studies, conducted in India are approved by US FDA, European member states, and equivalent regulatory authorities.

The pace for drug trials in the country is so fast that the Clinical Data Interchange Standards Consortium (CDISC), a U.S. non-profit organization committed to the development of clinical research organizations’ standards the world over, is looking at setting up its chapter in India.
CDISC is an open, multidisciplinary, organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in the industry. Even as the clinical outsourcing boom is beginning to explode, the Indian government is all set to further boost it. Officials in the health ministry said that the government might now consider giving permissions for pharmaceutical companies to conduct simultaneous trials in India and overseas.

Almost all of the top names in the pharmaceutical industry have zeroed-in on India, setting up clinical trial facilities in major cities, especially Hyderabad and Ahmedabad. Global consultancy McKinsey & Co estimated that by 2010, global pharma companies would spend around $1-1.5 billion just for drug trials in the country. Dr Vishwanath Reddy, a pharmaceutical consultant based in Hyderabad, is getting a steady stream of visitors. He says he gets at least one business call a week from a foreign company eager to set up clinical trials at his facility in India. Big Pharma is attracted to India by the facilities that India offers for pharma companies, their product developments and trials. The biggest advantages many look at are, of course, “India’s huge population of more than one billion, as well as the obvious cheaper costs,” Dr Reddy points out. Trials for a standard drug in the United States can cost about $150 million. A similar drug could be tested in India at a 60 percent reduction of that staggering cost. India currently stands as one of the highest ranked emerging countries in the global contract research industry, and it is expected to grow by 20 percent compounded annually over the next five years.

The global pharmaceutical market generates more than $800 billion a year in revenues and is expected to grow at a five to eight percent annual rate through 2014. This growth is likely to add nearly $300 billion in additional revenue – driving the total market to a staggering $1.1 trillion in 2014. CRO’s represent the highest growth segment of the pharmaceutical services industry. The global CRO industry, which was a $50 million market 30 years ago, was expected to grow into a $23 billion industry in 2012, with analysts projecting 10-14 per cent growth over the next several years. Whether India plays a part in this growth remains to be seen.

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6 Most Important Regulatory Documents In A Clinical Trial

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You may or may not be familiar with regulatory documents and all the intricacies that go along with regulatory activities for any given protocol at a research site. This post will briefly list your duties as they apply to regulatory activities at the research clinic level. It is important to note that there are two separate aspects to regulatory activities: study start up and maintenance. While you are free to delegate whatever you deem appropriate to your study coordinators, it has worked well in the past for many Research Clinics that the Site Director or Regulatory Specialist handle the start up regulatory activities, and once IRB approval is given and the study begins, the regulatory responsibilities may be handed to the study coordinators for proper maintenance. However, many issues will need to be examined during QA (Quality Assurance) sessions that are of the utmost importance to the compliance of a research clinic. Below are the regulatory items of exceptional importance and should be properly audited by your QA department regularly:

-Delegation of duties log

-Training documentation for all staff

-IRB continuing review reports

-All versions (and most recent version) of Informed Consent

-SAE reports (Serious adverse events)

-Updated 1572’s

These items of importance should receive special attention, and their importance should be communicated clearly to the study coordinators at every opportunity that is appropriate. Here is an old video done here on how to keep these documents organized.

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Is Online Clinical Trial Recruitment Reliable?

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For the past several years, the debate has gone on in the research community whether the advent of online recruitment strategies will end up paying off for Pharma and CRO companies in the form of faster enrollment times that would reduce delayed study completions. While I have written and done videos and interviews extensively on Pfizer’s groundbreaking virtual clinical trial, the jury is still out on whether the internet, web 2.0, and social media in general can help accelerate clinical trial participation rates and ultimately save the industry millions of dollars per year. While I certainly have my own opinions on these strategies, I ultimately believe that Quintiles may be on the right track with their MediGaurd platform. Medigaurd lets anyone upload what medications they’re taking in order to see whether they may have any possible drug-drug interactions. The user gets a great service to track their medications, and Quintiles esentially gets a database of patients with known diagnosis’ and medications who can be contacted in the future about clinical trials that they may qualify for. It is a good way to get people who do not know anything about clinical trials interested perhaps in joining a study. This recent article by MedCity News highlights some of the success that Quintiles has experienced with recruitment online as well as having the trial participants fill out certain patient reported outcomes online. The article reports that the patient reported outcomes are fairly accurate and theoretically can be trusted for future study use. This leads us directly to the future of clinical trials in which more virtual clinical trials can be done directly from the homes of the study participants without all the necessary steps of going to an actual research clinic. I’ve written about at-home clinical trials several weeks ago. I ultimately believe that a human element of having study participants understand what clinical trials are and combining this with technologies and platforms such as MediGuard can actually boost clinical trial recruitment as well as study retention.

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Using Social Media For Very Specific Clinical Trial Recruitment

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I get frequent emails at dan@theclinicaltrialsguru.com where viewers of this blog can ask me questions or open discussion on any topics that can stimulate some good dialogue. Today’s video is in response to a great email I received from a small research clinic out of the Colorado area. They are having a difficult time recruiting for some very specific clinical trials and are in need of some social media suggestions. First of all, I must admit that I love to get these kinds of questions because I am encouraged when I see research clinics out there making great efforts in social media. With that being said, I did some research regarding this viewer’s Fan Page and while they are doing all the right things such as being engaging, not spamming people, posting pictures, links and other relevant information that can genuinely help their target audience, I explain in the video that Facebook has been making it even harder for Fan Pages to show up in people’s feeds. There is a great article on that topic here. Without getting into too much detail as I describe in the video, I suggested they utilize other strategies in addition to Fan Pages such as Google ads, twitter, tumblr, and most importantly, getting a blog that is highly focused on the medical conditions they conduct as well as getting hyperlocal in their efforts to target the right people who may end up joining their studies. Two free services I highly recommend they utilize in order to keep their pulse on the greater conversation around their topics throughout social media is search.twitter.com and kurrently.com. If you don’t know what those are, you are really missing out. There is so much more to discuss here, and I didnt even get into Craigslist (check my video on that) or Pinterest (another video here). As always, I hope this post and video can help you out a little and shoot me more questions for further topics!

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Quintiles CEO Not Discussing Plans For IPO But Is Talking About How Clinical Trials Will Probably Work In The Future

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In an interview with the Triangle Business Journal, Quintiles CEO Tom Pike discussed what acquisitions Quintiles has been making and is planning to make over the next year. While he did keep hush about the well-publicized IPO (initial public offering) rumor, Mr Pike revealed what he believes will be a huge part of clinical trials over the next several decades: genomic sequencing and personalized medicine. Basically, personalized medicine allows for customized treatments for individuals based upon their genotype (DNA) and genetic markers. In fact, earlier this year, Quintiles acquired a genomics company called Expression Analysis. While it is clear that personalized medicine is going to be huge in the future, the way clinical trials will be conducted using genetic markers is still a bit uncertain. What is not uncertain is that Quintiles is investing heavily in their genomics capabilities, and if the industry leader is doing so, we should all pay attention. Mr Pike was quoted, “It’s a way for Quintiles to get ahead of the curve, integrating prematurely so that, when it’s an industry standard, it will be easier to adapt.” The article goes on further by saying that Quintiles will be making more acquisitions this year. I personally am betting on a few Chinese purchases as I reported on earlier this week. I will also go out on a limb and predict that Quintiles will go IPO sometime in 2013 or even 2014 as they can gain some cash to begin even greater expansion and further capitalize on global market share.

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How To Have A Smooth Monitoring Visit At Your Research Clinic

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One of the most important yet challenging activities for a research study coordinator when it comes to clinical trials is dealing with your monitors (CRA’s). We have written about site selection visits in the past and have also talked about how to effectively deal with monitors during their visits. Today’s video focuses on how to schedule monitoring visits properly so that you won’t be overwhelmed, your PI won’t be running all over the place, your study participants will have plenty of your attention, and your monitor will be happy. It can be very tempting for a coordinator to bite off more than they can chew and schedule monitoring visits during hectic days, but I do not recommend you do this as monitoring visits always demand plenty of your time, energy and focus . Let me know your thoughts on this.

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