“Cre­at­ing a more con­ducive en­vi­ron­ment will go a long way in en­cour­ag­ing more clin­i­cal re­search”

Dr Chi­rag Trivedi

BioSpectrum (India) - - BIO CONTENT - « Dr Chi­rag Trivedi Pres­i­dent, In­dian So­ci­ety for Clin­i­cal Re­search (ISCR)

Pres­i­dent, In­dian So­ci­ety for Clin­i­cal Re­search (ISCR)

In­dian So­ci­ety for Clin­i­cal Re­search (ISCR), an as­so­ci­a­tion of clin­i­cal re­search pro­fes­sion­als, aims to build aware­ness of clin­i­cal re­search as a spe­cialty in In­dia and to fa­cil­i­tate its growth while help­ing to evolve the high­est stan­dards of qual­ity and ethics. In an in­ter­ac­tion with Aish­warya Venkatesh of BioSpec­trum, Dr Chi­rag Trivedi, Pres­i­dent, ISCR shared his thoughts about the is­sues be­fore the in­dus­try and means of over­com­ing these chal­lenges.

What are ma­jor is­sues be­fore the in­dus­try?

The last few years have been a trans­for­ma­tive one for clin­i­cal re­search in In­dia. Im­por­tant reg­u­la­tory changes have led to a more sup­port­ive en­vi­ron­ment for con­duct­ing re­search. The num­ber of global clin­i­cal tri­als is slowly pick­ing up and it will take a year or two be­fore we see a sig­nif­i­cant in­crease. Over­all, there has been a pos­i­tive shift in peo­ple's at­ti­tudes and per­cep­tions about clin­i­cal tri­als but, given the huge dis­ease bur­den In­dia car­ries, a lot re­mains to be done.

Part of this is be­cause there is a still lack of aware­ness glob­ally about all the reg­u­la­tory changes that have taken place in the last few years and part of it is be­cause spon­sors are wait­ing for the en­vi­ron­ment to set­tle down fur­ther.

There are still a few ar­eas that need to be ad­dressed:

There is a need for bet­ter clar­ity on the ac­cred­i­ta­tion process of Ethics Com­mit­tees that is in­tended to take ef­fect from Jan­uary 1, 2018.

While the ap­proval process was stream­lined fur­ther re­cently, ap­proval time­lines are still around five months and we need them to come down fur­ther.

Due to the reg­u­la­tory chal­lenges of 2013, many in­ves­ti­ga­tors have stopped con­duct­ing clin­i­cal tri­als. Hence, there is some amount of work that needs to be done for the Physi­cian com­mu­nity and Ethics Com­mit­tees so that we can have a good num­ber of them con­duct­ing qual­ity clin­i­cal tri­als in fu­ture given the fact that the reg­u­la­tions have be­come more bal­anced and predictable and at the same time, are pro­tec­tive of the rights, safety and well­be­ing of trial par­tic­i­pants. Reg­u­la­tors too can play a sig­nif­i­cant role in build­ing con­fi­dence amongst var­i­ous stake­hold­ers.

Fi­nally we need to raise more aware­ness about the high qual­ity of clin­i­cal re­search that is be­ing done in In­dia and the good that it has done for our In­dian pa­tients.

In the larger con­text of In­dia’s unique health­care re­quire­ments and the grow­ing in­ci­dence of en­demic dis­eases and emerg­ing life­style dis­eases, we need clin­i­cal re­search to de­velop new and ef­fec­tive medicines and vac­cines to tackle our mam­moth dis­ease bur­den and un­met med­i­cal needs. In­dia has 17 per cent of the world’s pop­u­la­tion and 20 perc ent of the global dis­ease bur­den and yet, less than 1.4 per cent of global tri­als take place in In­dia.

What needs to be done to over­come these is­sues?

I do be­lieve that more aware­ness around the reg­u­la­tory changes, the high qual­ity of clin­i­cal re­search be­ing done in In­dia, our grow­ing bur­den of dis­ease and pa­tient pop­u­la­tion and re­it­er­a­tion by the reg­u­la­tors to cre­at­ing a more con­ducive clin­i­cal re­search en­vi­ron­ment will go a long way in en­cour­ag­ing more clin­i­cal re­search in In­dia.

Can In­dia bounce back as clin­i­cal re­search hub in the com­ing years?

I think the word ‘hub’ is a mis­nomer. In­dia was never a hub for clin­i­cal re­search and it re­ally does not mat­ter whether it is or not. What mat­ters is that the quan­tum of clin­i­cal re­search be­ing done in our coun­try should be pro­por­tion­ate to our dis­ease bur­den. Clearly it is not at the moment and the ones most im­pacted by this are pa­tients. We have a huge task on hand of fight­ing the un­met med­i­cal needs of In­dian pa­tients.

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