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全球醫療保健領域的電子同意市場 2023-2030Global EConsent in Healthcare Market 2023-2030 |
預計在預測期內(2023-2030年),全球醫療保健領域的電子同意市場的CAGR將達到 9.9%。市場的成長歸因於贊助商控制力的增強。電子同意解決方案中新增的分層授權選項和額外功能為贊助商提供了更多控制和自訂功能。這滿足了根據研究需求量身定做同意解決方案的願望。例如,2021年4月,Signant Health憑藉最新發布的Smart Signals 電子同意,拓展了電子知情同意產品並增強了自身能力。關鍵產品功能增強和分層許可選項為申辦者提供了對任何研究設計獲得電子知情同意和重新同意的額外控制。
全球醫療保健領域的電子同意市場按註冊類型、部署模式和表單類型細分。根據註冊類型,市場分為現場同意和遠端同意。根據部署模式,市場分為基於雲端的和基於網路的。此外,根據形式類型,市場細分為普遍同意、普遍同意但特定拒絕、普遍拒絕特定同意、普遍拒絕。基於雲端的子類別預計將佔據部署模式細分市場的很大一部分市場佔有率。該成長可歸因於擴大使用基於雲端的解決方案,因為它具有最大限度地減少管理負擔並保持站點和研究團隊合規性的好處。此外,基於雲端的電子同意透過結合創新技術和多媒體來改進流程,為潛在的試驗參與者提供互動式知情同意體驗。
在這些應用中,內容管理系統(CMS)細分市場預計將在全球醫療保健領域的電子同意市場中佔據相當大的佔有率。細分市場的成長歸因於不同人群的參與。現場電子同意可以服務於各種人群,包括具有不同程度的數位素養或技術使用受限的人群,能夠公平地獲取試驗材料。例如,2021年 7月,CASTOR 推出了可擴展的病患登記和 eConsent 平台。臨床試驗受益於權力下放,因為它使更廣泛的個人更容易獲得臨床試驗。該過程還鼓勵透明度和效率,透過在整個研究招募和入組過程中提供無縫過渡來減輕患者的負擔。
全球醫療保健領域的電子同意市場按地理位置進一步細分,包括北美(美國和加拿大)、歐洲(英國、義大利、西班牙、德國、法國和歐洲其他地區)、亞太地區(印度、中國、日本、韓國和亞洲其他地區)以及世界其他地區(中東和非洲以及拉丁美洲)。其中,歐洲預計將在全球市場中佔據顯著佔有率,因為該地區的醫療保健系統發達,此外還非常重視資料保護和患者權利,這使得 eConsent 解決方案成為一個有吸引力的選擇。日益增多的醫療保健數位化舉措,例如電子健康記錄和互通性標準的廣泛採用,為電子同意的部署提供了有利的環境。
在所有地區中,北美地區預計在預測期內將以相當大的CAGR成長。區域成長歸因於比較理解研究。比較患者對電子同意書與紙本知情同意書(ICF)的理解程度的比較研究已經產生了積極的結果。這些研究強調電子同意的改進或可比較知識有助於其被接受。根據美國國立衛生研究院(gov.)2023年 9月的資料,本次審查總共涵蓋了 36 項符合資格標準的研究,以及手動檢索的額外結果出版物。這些出版品總共描述了 35 項研究,其中 2 項研究各由 2 篇出版品涵蓋。大多數研究(28/35,80%)在北美進行,其中美國佔 26 項研究,加拿大佔 2 項研究。
此外,在對包括總共 8,778 名參與者的 26 項研究進行的綜合分析中,評估了與電子同意相關的患者理解程度。在這些研究中,有20 項專門比較了電子同意和紙本知情同意書(ICF)的理解程度,共有 6,769 名參與者提供了比較資料。研究結果表明,與紙本 ICF 相比,電子同意會表現出顯著更好的理解,或是在沒有統計意義的情況下更佳理解,或是總體理解沒有顯著差異。
Global EConsent in Healthcare Market Size, Share & Trends Analysis Report by Enrollment Type (On-site, and Remote Consent), by Deployment Mode (Cloud-based, and Web-based) and by Form Type (General Consent, General Consent with Specific Denial(s), General Denial with Specific Consent(s), and General Denial), Forecast Period (2023-2030)
The global econsent in healthcare market is anticipated to grow at a CAGR of 9.9% during the forecast period (2023-2030). The market's growth is attributed to the increased sponsor control. The addition of tiered license options and extra features in eConsent solutions offers sponsors more control and customization capabilities. This satisfies the desire for customized consent solutions based on the needs of the study. For instance, in April 2021, Signant Health, with the latest released of Smart Signals eConsent, the company has expanded its electronic informed consent products and strengthened its capabilities. Key product functionality enhancements and tiered license options offer sponsors additional control over getting electronic informed consent and reconsent for any study design.
The global econsent in healthcare market is segmented on the enrollment type, deployment mode, and form type. Based on the enrollment type, the market is sub-segmented on-site, and remote consent. Based on the deployment mode, the market is sub-segmented into cloud-based, and web-based. Furthermore, on the basis of form type, the market is sub-segmented into general consent, general consent with specific denial(s), general denial with specific consent(s), general denial. The cloud-based subcategory is expected to capture a significant portion of the market share within the deployment mode segment. The growth can be attributed to the growing use of cloud-based solutions owing to the benefits of minimizing administrative burden and maintaining compliance for sites and study teams. Furthermore, cloud-based eConsent improves the process by incorporating innovative technology and multimedia to provide potential trial participants with an interactive informed consent experience.
Among the application, the content management systems (CMS) sub-segment is expected to hold a considerable share of the global econsent in healthcare market. The segmental growth is attributed to the diverse populations engagement. On-site eConsent can serve a variety of demographics, including those with various degrees of digital literacy or restricted access to technology, enabling fair access to trial material. For instance, in July 2021,CASTOR Launched Scalable Patient Enrollment and eConsent Platform. Clinical trials benefit from decentralization as it makes them more accessible to a wider range of individual. The process additionally encourages transparency and efficiency, reducing the burden on patients by providing a seamless transition throughout the study recruitment and enrollment process.
The global econsent in healthcare market is further segmented based on geography including North America (the US, and Canada), Europe (UK, Italy, Spain, Germany, France, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia), and the Rest of the World (the Middle East & Africa, and Latin America). Among these, Europe is anticipated to hold a prominent share of the market across the globe, owing to the region's healthcare system is well-developed, in addition to is a significant emphasis on data protection and patient rights, making eConsent solutions an appealing option. The increasing healthcare digitization initiatives, such as widespread adoption of electronic health records and interoperability standards, present a conducive climate for eConsent deployment.
Among all regions, the North America regions is anticipated to grow at a considerable CAGR over the forecast period. Regional growth is attributed to the comparative comprehension studies. Comparative research comparing patient comprehension of eConsenting opposed to paper-based Informed Consent Forms (ICFs) has produced positive results. These studies emphasizing improved or comparable knowledge of eConsenting assist to its acceptance. According to the National Institute of Health (gov.) in September 2023, a total of 36 studies meeting the eligibility criteria were included in this review, along with an additional outcomes publication that was retrieved manually. These publications described a total of 35 studies, with 2 studies covered by 2 publications each. The majority of the studies (28/35, 80%) were conducted in North America, with the US accounting for 26 studies and Canada for 2 studies.
Furthermore, in a comprehensive analysis of 26 studies involving a total of 8,778 participants, the aspects of patient comprehension were evaluated in relation to eConsenting. Out of these studies, 20 specifically compared comprehension between eConsenting and paper-based informed consent forms (ICFs), with a total of 6,769 participants contributing comparative data. The findings indicated that eConsenting demonstrated either significantly better understanding, better understanding without statistical significance, or no significant differences in overall comprehension when compared to paper-based ICFs.
The major companies serving the econsent in healthcare market includes Magentus Group Pty Ltd., Medable, Inc., Medrio, Inc., ObvioHealth, and Veeva Systems and others. The market players are considerably contributing to the market growth by the adoption of various strategies including mergers and acquisitions, partnerships, collaborations, funding, and new product launches, to stay competitive in the market. For instance In June 2022, uMotif partnered with ClinOne to provide a seamless experience for patients, caregivers, and sites of proven traditional, DCT, and hybrid trial solutions for eConsent, eCOA / ePRO, behavioral engagement, sensors and wearables, and more.