Friday, September 18, 2009

Where are the PIs?

Once ever so often, in public forums/conferences etc of the CR industry in India or behind the scenes discussions, I hear someone or the other raise this concern-The Principal Investigator is THE key player in the clinical trials we do and we hardly ever have Investigators participating/present in CR workshops or conferences. Shouldn’t we ensure that they too attend?

The discussions go round and round and reach nowhere really yet again!!

I don’t know what or how you feel about this but I can’t help but roll my eyes and groan –oh no, not again!!

Drastic reaction, do you think?

My two bits on this is-

1. The PI is not THE key player in CTs!  Important yes, THE key to recruitment yes!

But THE key player- is the patient!

How come we are not talking about patient help or support groups and communities to be a thriving part of such gatherings?

Happens in the USA for instance, but very rarely here.

2. The PI (and the ones everyone wants as PIs anyway) are important busy people. Why on earth would they want to attend a conference/workshop that caters nothing for them?

One lone lecture by a KOL does not an important conference make.

If you look at the agenda of any one of the now many conferences that are organised around the country, it solely caters for those in the CR industry and pharma companies.

Why should then a doctor attend????

A gynaec doesn’t attend a conference on arthritis and a dermatologist will not attend one on irritable bowel’s, so why would they attend a conference that talks mostly of things they don’t really need to know. Just curious, How many of the people in CR industry attend Doctor’s conference except if invited as a speaker?

So is it that the twain shall never meet?

Not really, until we as an industry raise awareness about clinical research, its requirements and methodologies where it matters most.

Amongst the medical college graduates and postgraduates, disease support groups and media.

We DO need investigators, and good investigators at that. And we need them today and ten years later too.

We need to build capacity AND capability.

Like it is said that the best time to plant a tree was twenty years back, but the second best time is now.

We should have thought of all our key players ten years back, but nevertheless it is not too late yet.

Before training comes building awareness and the places to start are medical colleges and no not the professors, but the medical student’s, (graduates and post graduates) they are the PIs of tomorrow and more eager to learn and more often than not work as CRCS at academic sites.

Once that happens there automatically would be pressure on the senior docs to know more and be a more active participant to the process.

 Then comes focused training of potential sites and PIs.

The current level of well meaning but fragmented efforts at PI training on GCP etc is good but by itself wont achieve the rate and results expected.

I had one grand dad write to me on wanting to find some information about CTs running in India on Duchene’s muscular dystrophy. Garnering the support of and educating Support communities for illnesses such as these makes a lot of sense for bringing the right trial to the right person and helping someone maybe, who is living on little other than hope.

There is a lot waiting to be done, but the number one is to start asking the RIGHT questions!!!

 

 

 

 

Saturday, March 14, 2009

Careers in Clinical Research

Careers in Clinical Research

CRO is the new BPO, or call it KPO if you like to.

Contract outsourcing by any name or rather many names! Clinical Research, the new career option for the medical, paramedical, life sciences graduates and postgraduates is less about research and more about development.
So les get a few facts straight, It is not about discovering new drugs, not about exciting Eureka moments in the lab for the next best thing in prolonging life, eliminating obesity, zapping cancers, producing designer babies or reading people’ minds!
It is about running trials or collecting, entering, analyzing, reporting data on a day to day basis ,that prove/disprove that the drugs under development are safe and effective for patients.

And you do it the way the regulatory (read govt agencies) ask you to and you do it in a way that your conscience lets you sleep a night of peace.

Which basically means you follow plenty of rules and regulations all the time, (not just when someone is watching) and you learn to deal effectively with data, documents, records, paper, non-paper, some useful, some just plain fanciful!

Oh, So does everyone do this? Allopathic Doctors, Pharamacists, Life sciences people, Physiotherapists, Ayurveds, homeopaths, other graduates?

Ah,Yes! Everyone, except in different shades of green and degrees of separation.

But why am I talking about this? Because every day , my mailbox is flooded with young, bright hopefuls looking for a suitable opportunity in my small company.

What is this suitable opportunity? And what happens after the opportunity comes by?

Here lies the catch. The PGDCR diploma givers tell you that the industry is awash with opportunity, and fat salaries, and charge you a bomb for telling you that.
Being a CRA is what you dream of or its Data management companies you seek.
What they don’t tell you is that the fat salaries happen by and by, not on the first day of your first job and it does not help to jump jobs at the next 5% raise offer that comes along.. What they don’t tell you is that if you have a rock solid degree, which is in demand, you would have still got the great job without the diploma for which you took a loan. What they don’t tell you is that though you all might have done the same course and learnt the same things, the Industry will look at what professional degree you hold prior and offer you opportunities accordingly.
Which essentially means your PGDCR helps but is not the golden key that fits all doors.

But the industry excites you and you still want to be part of it. And it’s a great career you dream of. What do you do and how??
Is there more to this industry than being a CRA and what are the challenges it offers, in my next post.

Till then……

Saturday, February 21, 2009

Been a while....too long

Been a while since I was here last.

Been on my mind though, that I need to get back, more for my own self than anything else. But like all things in life, it is the getting started, the first step which takes the longest, even if it is to some place you have been before.

Much water has flown under the bridge meanwhile.
The clinical Research industry in India has moved forward, backward, and also sideways. Some good, some not so good and some plain difficult to understand!

The industry is growing and has thrown open a lot of opportunities in the last decade, which many of us might not have thought possible. But sometimes we tend to forget that most of this work comes from outside, and was somewhere else yesterday and might go somewhere else tomorrow….. unless!
Unless we strengthen our strengths (What are they?) and work on our weaknesses (why? Do we have any???)

So how about sharing with me, what you think are our strengths and what you think our weaknesses? Would love to hear from you.
Meanwhile, I promise to be here more often, and ask you to drop by too.