“Data shar­ing, post study ac­cess to trial med­i­ca­tion are emerg­ing fron­tiers”

BioSpectrum (India) - - BIO CONTENT -

“Data Shar­ing and Post study ac­cess to trial med­i­ca­tion for study sub­jects are the two emerg­ing fron­tiers in clin­i­cal re­search space,” said Dr Saral Thangam, CEO & Managing Direc­tor, Nor­wich Clin­i­cal Ser­vices.

Speak­ing at a con­fer­ence on “CLINICA: Re­cent trends and ap­proaches in Clin­i­cal re­search, Clin­i­cal trial and Med­i­cal writ­ing” or­gan­ised by ABC Biolog­ics in Bangalore on September 1, she said “Data shar­ing, whether elec­tive or re­quired, cre­ates an obli­ga­tion for the orig­i­nal in­ves­ti­ga­tors who ob­tain fund­ing, de­sign stud­ies, col­lect and an­a­lyze data, and pub­lish re­sults to make their cu­rated data and as­so­ci­ated”.

She fur­ther noted that data from well-designed and well-ex­e­cuted re­search not only are use­ful for the orig­i­nal pur­pose and secondary analy­ses by the orig­i­nal re­searcher but also can be re­pur­posed for a va­ri­ety of ap­pli­ca­tions, in­clud­ing in­de­pen­dent repli­ca­tion, avoid­ance of du­plica­tive stud­ies, gen­er­a­tion or test­ing of new hy­pothe­ses, and the gen­eral ad­vance­ment of clin­i­cal and bi­o­logic un­der­stand­ing.

Talk­ing about Post Trial re­spon­si­bil­i­ties: con­tin­ued ac­cess to trial med­i­ca­tion she ob­served that in­formed con­sent for con­tin­ued ac­cess to med­i­ca­tion must be ob­tained. “The reg­u­la­tions that bind this com­plex topic is still un­der evo­lu­tion,” she con­cluded.

Speak­ing on “Evolv­ing global reg­u­la­tory ex­pec­ta­tions on data in­tegrity”, Dr Shrini­vas Savale, Phar­ma­ceu­ti­cal and Bio­phar­ma­ceu­ti­cal Con­sul­tant, Ahmed­abad said “With the reg­u­la­tory in­spec­tions world over iden­ti­fy­ing sev­eral in­ci­dences of crit­i­cal/ ma­jor gaps in the com­pli­ance to var­i­ous GxP re­quire­ments, a lot of em­pha­sis has been given on data in­tegrity, and thus, re­li­a­bil­ity of the data sup­port­ing any reg­u­la­tory ap­provals.”

Dur­ing his pre­sen­ta­tion he thrown some light on the need/ap­proaches for en­sur­ing data in­tegrity through good process con­trols (QMS with data gov­er­nance), data shar­ing/trans­parency as well as global ini­tia­tives in the era of ‘big data’ and tech­no­log­i­cal ad­vance­ments in clin­i­cal re­search in com­ing years.

Talk­ing on “Ethics Com­mit­tees - re­cent de­vel­op­ments & Chal­lenges in Sci­en­tific and Eth­i­cal Review” Na­gen­drappa. M. H, Chief Ex­ec­u­tive Of­fi­cer, Clinotek In­dia - Cen­ter for Ad­vanced Clin­i­cal Re­search Stud­ies, Bangalore said that for all prac­ti­cal rea­sons, it is im­pos­si­ble for reg­u­la­tory au­thor­i­ties to be present at all clin­i­cal trial sites to en­sure safety for the par­tic­i­pants. They rely on Ethics Com­mit­tees (ECS) to en­sure pro­tec­tion of trial sub­jects.

He also pointed out the gross neg­li­gence hap­pen­ing in the stage of in­formed con­sent process which is one of the most im­por­tant, but un­for­tu­nately the most ig­nored in In­dia. As a re­sult of the above and not lim­ited to, there were over 2000 cases of se­ri­ous ad­verse events (SAEs) lead­ing to death were re­ported since 2009. In very few cases, the com­pen­sa­tion was paid to the vic­tim's fam­ily. To pre­vent sci­en­tific mis­con­duct and bet­ter han­dle the iden­ti­fi­ca­tion and re­port­ing of SAEs, it was in­evitable for Cen­tral Drugs Stan­dard Con­trol Or­ga­ni­za­tion (CDSCO) to im­ple­ment strict measures in place to en­sure the pro­tec­tion of rights, safety and well­be­ing of trial par­tic­i­pants

Be­sides, Dr Sam T Mathew, Head-Clin­i­cal e-Sub­mis­sion and Tech­ni­cal Com­pli­ance De­liv­ery, Sci­en­tific and Med­i­cal writ­ing, Glax­oSmithK­line, Bangalore spoke on “Author­ship in Clin­i­cal Public­tions: Is there a way to Quan­tify the Con­tri­bu­tions?”, Dr Anand Eswara­iah, Head Bio­met­rics, Med­i­cal and Reg­u­la­tory Af­fairs, Syn­gene In­ter­na­tional, Bangalore on “In­no­va­tion and Fu­ture Clin­i­cal Tri­als”, Ran­jith P.U, Se­nior As­so­ciate Man­ager (QC), Eli Lilly ser­vices In­dia on “Med­i­cal writ­ing de­liv­er­ables-Dif­fer­ent At­tributes of Qual­ity” and Dr Sha­bana Khan, Se­nior Man­ager PK/ PD, Nav­i­tas Life­sciences, Bangalore on “Stem Cells in Clin­i­cal Tri­als” at the one day con­fer­ence.

Rep­re­sen­ta­tives from MSN Pharma, Bio­clin­ica, D2L Clin­i­cal So­lu­tions, Nor­wich Clin­i­cal Ser­vices, Panex­cell Clin­i­cal Lab, Clinotek, Saptha­giri Clin­trac, Alchemy Clin­i­cal Re­search Ser­vices, Bioin­tegrity, and In­sti­tute of Clin­i­cal Re­search In­dia (ICRI) were present dur­ing this con­fer­ence. The con­fer­ence con­cluded with adop­tion of a res­o­lu­tion in which its par­tic­i­pants set forth their rec­om­men­da­tions to fu­ture of clin­i­cal tri­als.

Del­e­gates pos­ing with speak­ers of CLINICA -2017

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