![]() |
½ÃÀ庸°í¼
»óǰÄÚµå
1358186
¼¼°èÀÇ ºÐ»êÇü ÀÓ»ó½ÃÇè ¼ºÀå ±âȸGlobal Decentralized Clinical Trials Growth Opportunities |
°æÀï ½ÉÈ·Î Àü ¼¼°è °÷°÷¿¡¼ DCT ÀÌ´Ï¼ÅÆ¼ºê ÃßÁø ÆÄÆ®³Ê½Ê¿¡ ±â¹ÝÇÑ ¼ºÀå ¸ðµ¨·Î ³ª¾Æ°¡°í ÀÖ½À´Ï´Ù.
¼¼°è ºÐ»êÇü ÀÓ»ó½ÃÇè(DCT) ½ÃÀåÀº COVID-19 ÆÒµ¥¹Í ÀÌÈÄ Áö¼ÓÀûÀ¸·Î ±Þ¼ºÀåÇϰí ÀÖÀ¸¸ç, 2020³â DCTÀÇ µµÀÔÀÌ °¡¼ÓȵǴ ¹è°æ¿¡´Â ÀÓ»ó½ÃÇèÀ» ¼öÇàÇÏ´Â ÀÓ»ó½ÃÇè Ã¥ÀÓÀÚ, ÀÓ»ó½ÃÇè Çù·ÂÀÚ ¹× ȯÀÚÀÇ À̵¿ÀÌ Á¦Çѵǰí Àü ¼¼°èÀûÀ¸·Î ÀÓ»ó½ÃÇè Ȱµ¿ÀÌ Å©°Ô Áß´ÜµÈ ÀÖ½À´Ï´Ù. ȯÀÚÀÇ ¾ÈÀü°ú ¿¬±¸°³¹ß Ȱµ¿ÀÇ ¿¬¼Ó¼ºÀ» º¸ÀåÇϱâ À§ÇØ ´ëºÎºÐÀÇ ÀÓ»ó½ÃÇè ÀÇ·ÚÀÚ¿Í ÀÓ»ó½ÃÇè¼öʱâ°ü(CRO)Àº ¿ø°ÝÀÇ·á, ¿ø°Ý ¼Ò½º µ¥ÀÌÅÍ °ËÁõ, ¼¾¼/¸ð¹ÙÀÏ ±â¼ú¿¡ ´ëÀÀÇÏ´Â Á÷Á¢ µ¥ÀÌÅÍ Ä¸Ã³ ¼Ö·ç¼Ç µî ÀÓ»ó½ÃÇè ¾÷¹«¸¦ Áö¿øÇÏ´Â µðÁöÅÐ ÅøÀ» µµÀÔÇß½À´Ï´Ù. äÅÃÇϰí ÀÖ½À´Ï´Ù.
Àü ¼¼°è ±ÔÁ¦ ±â°üµéÀº DCTÀÇ ÀÎÁöµµ¸¦ ³ôÀ̱â À§ÇØ DTRA(Decentralized Trials & Research Alliance)¿Í °°Àº ±âÁ¸ ¾ó¶óÀÌ¾ð½º¿Í ÇÔ²² DCT ¾ç½ÄÀÇ ´ë±Ô¸ð µµÀÔÀ» À§ÇÑ ÀÌ´Ï¼ÅÆ¼ºê¿Í °¡À̵å¶óÀÎÀ» Á¦½ÃÇÏ¸ç ¿ø°Ý ½ÃÇèÀÇ µµÀÔÀ» ÃËÁøÇϰí ÀÖ½À´Ï´Ù.
ºÏ¹Ì Áö¿ªÀº DCT º¥´õ, CRO, Á¦¾à»ç ½ºÆù¼µéÀÇ °·ÂÇÑ ÀÔÁö¸¦ ¹ÙÅÁÀ¸·Î DCT ½ÃÀåÀ» ÁÖµµÇϰí ÀÖ½À´Ï´Ù. ÇÏÁö¸¸ ¾Æ½Ã¾ÆÅÂÆò¾çÀº ȯÀÚÀÇ ´Ù¾ç¼º, ¹ÌÄ¡·á Àα¸, ºñ¿ë ¿ìÀ§¸¦ ¹ÙÅÁÀ¸·Î ¿©·¯ ¼¼°è CRO°¡ źźÇÑ ÀÔÁö¸¦ ±¸ÃàÇÏ¸é¼ Áß¿äÇÑ Áö¿ªÀ¸·Î ºÎ»óÇϰí ÀÖ½À´Ï´Ù. ¶ÇÇÑ, ÀÌ Áö¿ªÀº ¿ø°ÝÀÇ·á¿Í ePharmacy ¼Ö·ç¼Ç¿¡ ´ëÇÑ ÀÇÁ¸µµ°¡ ³ô¾ÆÁö°í ÀÖ¾î ÇâÈÄ 3-5³â ³»¿¡ DCTÀÇ º¸±ÞÀÌ È®´ëµÉ °ÍÀ¸·Î ¿¹»óµË´Ï´Ù. ´Ù¸¥ Áö¿ª¿¡¼´Â »ç¿ìµð¾Æ¶óºñ¾Æ¿Í µÎ¹ÙÀ̸¦ ÇʵηΠÁßµ¿ Áö¿ªÀÌ ¿ø°Ý ÀçÆÇ µµÀÔ È®´ë¸¦ À§ÇÑ Áغñ¸¦ Çϰí ÀÖ½À´Ï´Ù. Oracle, AWS µî ¿©·¯ ±â¼ú º¥´õµéÀÌ ÀÌ Áö¿ª¿¡ °ÅÁ¡À» µÎ°í eClinical ¼Ö·ç¼ÇÀÇ µµÀÔÀ» °¡´ÉÇÏ°Ô ÇÏ°í ¼ºÀåÀ» ÃËÁøÇϰí ÀÖ½À´Ï´Ù. ±×·¯³ª ÇöÀç ÀÌ ½ÃÀåÀÇ ¼ºÀåÀº ´Ù¸¥ Áö¿ª¿¡ ºñÇØ »ó´ëÀûÀ¸·Î ¿Ï¸¸ÇÏ°Ô ÁøÇàµÇ°í ÀÖ½À´Ï´Ù.
¸ñÀû¿¡ ¸Â´Â Ŭ¶ó¿ìµå ±â¹Ý Ç÷§Æû ¼Ö·ç¼ÇÀ» ÅëÇØ ºÐ»êÇü ÀÓ»ó½ÃÇèÀ» Áö¿øÇØ¾ß ÇÒ Çʿ伺ÀÌ Ç×»ó Á¸ÀçÇÕ´Ï´Ù. µû¶ó¼ CRO´Â ±â¼ú º¥´õ¿Í Çù·ÂÇÏ¿© ºÐ»êÇü ÀÓ»ó½ÃÇèÀ» À§ÇÑ ±â´ÉÀ» ±¸ÃàÇϰí ÀÖ½À´Ï´Ù. ¶ÇÇÑ, ȯÀÚ¸¦ À§ÇÑ ¿Â¶óÀÎ ±³À° ¸ðµâ°ú µð¹ÙÀ̽º, 꺿, ¼¾¼¸¦ Ȱ¿ëÇÑ ÀçÅà ½ÃÇè ¸ð´ÏÅ͸µÀ» À§ÇÑ º¸¾È ±â¼úÀÌ ÆÒµ¥¹Í ÀÌÈÄ ºÐ»êÇü ½ÃÇèÀÇ Ã¤ÅÃÀ» ÃËÁøÇϰí ÀÖ½À´Ï´Ù.
½ÅüÀû Àå¾Ö³ª Àå¼ÒÀû Á¦¾àÀÌ Àִ ȯÀÚ¸¦ À§ÇÑ ÀçÅÃÀÇ·á ¼ºñ½º´Â ÀÓ»ó½ÃÇèÀÇ Áö¼ÓÀ» ÃËÁøÇÒ ¼ö ÀÖ½À´Ï´Ù. ÈÞ´ë¿ë ±â±â »ç¿ë¹ýÀ» ±³À°¹ÞÀº °£È£»ç°¡ Áö¿øÇÏ´Â ÀçÅÃÀÇ·á ¼ºñ½º Á¦°ø¾÷ü¿Í Çù·ÂÇϸé DCTÀÇ ¿øÈ°ÇÑ ¼öÇàÀ» ÃËÁøÇÒ ¼ö ÀÖ½À´Ï´Ù. ¶ÇÇÑ, CRO´Â ¿ËÈ£ ±×·ì, ¼Ò¼È ¹Ìµð¾î, ¿Â¶óÀÎ ÀÇ»ç Ãßõ ½Ã½ºÅÛ È°¿ë, AI Áö¿ø Ç÷§Æû µµÀÔ µî ´Ù¾çÇÑ Ã¤³ÎÀ» ¸ð»öÇÏ¿© DCT »ýŰ踦 È®ÀåÇÔÀ¸·Î½á ½ÃÇè µî·Ï ¹× ȯÀÚ Âü¿© Àü·«À» Çõ½ÅÇÏ´Â µ¥ ÁÖ·ÂÇϰí ÀÖ½À´Ï´Ù.
Strong Competitive Intensity is Advancing DCT Initiatives Across the World Paving Way for a Partnership-based Growth Model
The global decentralized clinical trial (DCT) market has been witnessing a continued surge after the COVID-19 pandemic. The accelerated DCT adoption in 2020 was driven by restricted mobility of site investigators, clinical research associates, and patients to participate in trials, which resulted in a significant halt in trial activities worldwide. To ensure patient safety and continuity in the R&D activities, most sponsors and contract research organizations (CROs) adopted digital tools to support trial operations, including telemedicine, remote source data verification, and sensor/mobile technology-enabled direct data-capture solutions.
Regulatory agencies around the world are coming up with initiatives and guidelines for large-scale adoption of DCT modalities, alongside existing alliances, such as Decentralized Trials & Research Alliance (DTRA), that work toward increasing DCT awareness, propelling remote trial uptake.
North America continues to lead the DCT market owing to a strong presence of DCT vendors, CROs, and pharma sponsors in the region, followed closely by Europe, which has abundant infrastructure for large-scale DCT uptake. Nevertheless, Asia-Pacific is emerging as a crucial region with several leading global CROs establishing strong bases due to patient diversity, treatment-naive population, and significant cost advantage. In addition, there is a growing reliance on telemedicine and ePharmacy solutions in the region, which will propel DCT uptake in 3 to 5 years. In the Rest of World region, the Middle East is gearing up for greater remote trial adoption, with Kingdom of Saudi Arabia and Dubai at the forefront. Several tech vendors, such as Oracle and AWS, have set up bases in the region to allow the uptake of eClinical solutions, promoting growth. However, at present, the market will have comparatively slower growth than other regions.
There will be a constant need to support decentralized trials through cloud-based platform solutions that are fit to purpose. Therefore, CROs are building decentralized trial capabilities by partnering with technology vendors. In addition, online training modules for patients and secure technology for at-home trial monitoring through devices, chatbots, and sensors have been driving the adoption of decentralized trials after the pandemic.
Home health services for patients with physical disabilities and restricted access due to location can promote retention in clinical trials. Partnering with home health service providers supported by nurses trained in portable equipment usage will facilitate smooth DCT implementation. In addition, CROs are focused on innovating trial enrollment and patient engagement strategies by exploring multiple channels, such as the use of advocacy groups, social media, and online physician referral systems, as well as implementing AI-enabled platforms, expanding the DCT ecosystem.