Clinical trial tih hi eng nge ni? Hemi chungchang hi awlsam takin han sawi ila!

‘Clinical trial’ tih thumal hi i hre ngai em? Movie-ah emaw, chanchinbuah emaw i hmu tawh mai thei. Mi thenkhat chuan thil lian tak, hlauhawm tak niin an ngai. Mahse a nihna takah chuan tunlaia damdawi leh enkawlna kan hman tam tak hi hetiang zirchianna avang hian siam a ni. An tel lo chuan damdawi thar, nunna chhanhim thei tur chu a awm lo ang. Chuvangin, vawiin hian ‘clinical trial’ chu eng nge a nih, eng nge a nih, engtin nge a tih tih, a hlawkna leh a hlauhawmna te kan sawi dawn a ni.

A awlsam zawngin, clinical trial chu eng nge ni?

A awlsam khawp mai. Clinical trial hi medical research study a ni a, mi volunteer te an tel a ni. Hengte hi enkawlna thar hian hna a thawk tak tak em tih leh mi tan a him em tih hriat theihna awmchhun a ni.

He zirchianna hi thil chi hrang hrang chungchang a ni thei.

• Natna thar hmuhchhuah dan tur chungchang.
• Natna laka inven dan tur chungchang.
• Damdawi thar chungchang, damdawi engemaw zat inzawmkhawm chungchang, damdawi hmanraw thar chungchang.

He thuziak ah hian enkawlna thar chungchanga zirchianna chungchang kan sawi tam ber ang. A châng chuan, damdawi lam dinhmun i neih avângin, chu chu enkawlna thar hmuh theihna tûr kawng khat atân i inrawlh duh mai thei. Tin, mi hrisel tak tak, damlo lo tak tak te pawhin medical science tihhmasawn leh midang damlote tanpui turin an inpe bawk.

Research project kan tan hmain eng nge thleng thin?

Clinical trial chu vawi khatah tan theih a ni lo. Chumi hma chuan kalphung rei tak a awm a ni. Kawngpui zirchian te, car enfiah te, leh zin rei tak kal hmaa engkim buatsaih ang maiin han ngaihtuah teh.

• Preclinical tests: Research zawng zawng hi ngaihtuahna atanga tan a ni. Chu chu "He damdawi thar hian he natna atan hian hna a thawk dawn" tih ang chi ngaihtuahna a ni. Tichuan he damdawi hi laboratory-ah test hmasa ber (laboratory test) a ni a, a chang chuan rannungah (studies in animals) a awm bawk.
• Clinical trial protocol: Test hmasa ber atanga enkawlna thar hian hlawhtlinna chance a nei tih a hriat chuan zirchiangtute chuan ruahmanna chipchiar tak tak an siam thin. Hei hi ``protocol'' an ti a, trial an tih chhan, eng treatment nge test tih te, trial tawp lamah ``trial endpoints'' te hian eng nge teh tura beisei tih chiang takin a sawi tur a ni.
• Phawmna lak: 1.1.Kan ramah pawh, khawvel ram dang ang bawkin, mi inrawlhna zirchianna kan neih hmain, chu ram chhunga hriselna lama thuneitute (entir nan, Sri Lanka rama National Medicines Regulatory Authority - NMRA ang institution atanga) leh zirchianna neitu damdawi in emaw institution emaw special ethical committee (Institutional Review Board - IRB emaw Ethics Committee) atanga phalna lak hmasak a ngai a ni. He committee hian a tum ber chu zirchiannaa telte himna leh dikna chanvo enkawl a ni.

Heng phalna zawng zawng hi an dawn hnuah chauh zirchiangtute chuan tel duh mi an zawng tan thei ang.

Thil pawimawh tak chu: Informed Consent

Clinical trial-a tel tur i ngaihtuah a nih chuan hei hi a pawimawh ber a ni. Paper i sign mai mai a ni lo. Research team nen hian chipchiar taka sawihona a ni.

He ``Informed Consent'' kalpui chhung hian research team chuan engkim an hrilhfiah vek che a ni.

• Research-in a tum ber chu engte nge ni?
• Eng enkawlna nge i neih theih?
• Eng chen nge hetiang hian a awm tawh?
• Eng hlauhawmna leh hlawkna nge i tawn theih ang?
• Hemi nena inzawm lo enkawlna dang eng nge i dawn theih?
• Engmah a senso che em?
• Engtin nge i mimal chanchin chu thuruk i vawn?

Heng zawng zawng hi chhiar tur document pek i ni ang. Tlem a buaithlak thei hle a, chuvangin zawhna i neih apiang chu eng ang pawhin tlem mahse zawt hreh suh.

Trial thenkhat chu ``randomized.'' Chu chu, damdawi thar emaw, tuna standard treatment awm mek, coin flipping ang chi, i dawn leh dawn loh chu random takin an rel tihna a ni. Hei pawh hi i hriat lawk tur a ni.

Clinical Trial neihna tur Phase hrang hrang

Damdawi thar chungchanga zirchianna hi a tlangpuiin phase lian pali a awm thin. Phase tin hian tum hrang hrang an nei a, phase tin atan volunteer thar lak an ni.

Clinical trial-a tel hian eng hlawkna leh hlauhawmna nge a neih?

Eng thil pawh ang bawkin hlawkna a awm bakah hlauhawmna a awm bawk. Heng zawng zawng hi ``Informed Consent'' kalpui chhung hian hrilhfiah a ni ang.

Hlawkna awm thei te

• Enkawlna thar ber berte hmuh theihna: Damdawi thar ber ber, market tlangpui la thleng lote dawn theihna hun remchang i nei thei a, chu chu enkawlna awmsa aiin a hlawhtling zawk mai thei.
• I hriselna chunga thununna tam zawk: I dinhmun leh i enkawl dan chungchang zir belh la, i medical team te nen thawhhona tha tak nei rawh.
• Midangte tanpui: I telna hian nakin lawkah nangmah ang bawka dinhmun nei mi sang tam tak a pui thei ang. Mi hrisel tak anga i tel hian medical science hmasawnna kawngah nasa takin i thawhhlawk a ni.

Risk awm thei te

• Side effects: Experimental treatment thar hian beisei loh side effects a thlen thei a, chu chu damdawi lam enkawlna a ngai thei bawk.
• Hun leh inpekna tam zawk: Damdawi inah i lo kal fo a ngai mai thei a, test i neih a ngai mai thei a, enkawlna atan pawh damdawi inah a tlangpui aia rei i awm a ngai mai thei bawk.
• Enkawlna hlawhchham: Enkawlna thar hian i tan hna a thawk lo thei a, a nih loh leh tuna enkawlna pangngai aiin a tha zawk lo thei bawk.
• Enkawlna thar dawng lo: Randomized trial-ah chuan, kan sawi tawh ang khan, enkawlna thar ai chuan tuna standard treatment i dawng thei a, a nih loh leh damdawi active lo placebo pawh i dawng thei bawk.

Zawhna thenkhat i zawh tur

Clinical trial i zawm hmain zawhna tam tak i nei mai thei. Chu chu thil pangngai a ni. Research team te hnena zawhna pawimawh tak tak i zawh theih te chu hetiang hi a ni.

• Engvangin nge he zirchianna hi tih a nih?
• Hemi kawngah hian eng chen nge ka inrawlh a ngai ang?
• Enkawlna ka dawng a nih chuan engtin nge pek a nih ang (pill angin, IV angin, emaw, hmanraw dang angin)?
• Vawi engzat nge ka lo kal a ngai dawn? Khawiah nge ka lo kal a ngai ang?
• Vawikhat thleng tur chuan eng chen nge a ngaih?
• He zirchiannaah hian eng thil pawh ka pek a ngai dawn em ni?
• Eng nge a hlauhawmna? Engtin nge ka hriselna a nghawng theih?
• Hemi hi ka zawm lo emaw, a chanve vel ka chhuahsan loh emaw chuan ka damdawi lam enkawlna pangngai chu engtin nge a awm ang?
• Ka damdawi lam enkawlna hi tuin nge mawhphurtu?
• He zirchianna result hi min hriattir dawn em ni?
• He enkawlna hi a hlawhtling a, pawm a nih chuan ka dawng chhunzawm thei ang em?
• Side effect na tak ka neih chuan zirchianna atang hian ka inhnukdawk thei ang em?

Clinical trial leh regular treatment hi eng nge a danglamna?

Hei hi mi tam takin an buai em em a ni. Damdawi lam thil avanga clinical trial-a i tel a nih chuan i hriselna lama harsatna pangngai (e.g., zunthlum, thisen sang) te chu i doctor pangngai leh medical team-in an enkawl chhunzawm zel ang.

Clinical trial enkawltu team hian damdawi thar emaw, enkawlna thar emaw test mek chauh an ngaihtuah a ni. I taksain enkawlna thar a dawn dan an enfiah a, a side effect awm thei apiang an enkawl bawk. Hei hian medical team pahnih atanga enkawlna i dawng dawn tihna a ni.

A tawpah chuan clinical trial hi medical science hmasawnna tur engine a ni. Pawn lam mite tân chuan science ang maia lang mah se, an thinlungah chuan damdawi lam enkawlna tihchangtlunna kawnga ṭanpui tûra inpe mite an awm a ni. An tel lo chuan zirchiangtute chuan damdawi thar chu a him leh him loh an hre thei ngai lovang.