The first batch of top 10 cases of DCT practice implementation in 2023 released by the CMAC DCT Alliance Susu Technology Project was selected.
2023 DCT Practice Case No.
2. The third batch will be released at an opportune time after the Spring Festival. The detailed version of all practical cases will be unveiled on March 21-24 in the poster area on the 2nd floor of Hall A, China (Suzhou) Conference on Innovative Drug Medicine and 2024 CMAC Annual Meeting.
In no particular order.
Pfizer DCT in practice
The application of electronic information in post-market commitment research
Project Leader: Hua Xinyi, Technical Director of Pfizer China.
Summary. This case is applicable to clinical trials in different fields, in order to explore the application of electronic information in post-marketing commitment research, the purpose is to explore the feasibility of the application of electronic information in clinical trials in China from the level of regulations, clinical operations, and technology, and to understand and overcome the difficulties of electronic informed landing from the post-marketing commitment research.
Work something out. The feasibility of e-knowledge in China.
Innovative features. From traditional knowledge to electronic knowledge, the first example of electronic knowledge.
Project Introduction. There are very few econsent cases officially landed in China, and our econsent project is the earliest batch of attempts in the industry, for the DCT track, Pfizer's attempt at econsent is an innovation and development, and it also gives other colleagues the confidence to try.
This case study is an applied analysis of the research on the post-market commitment of electronic information. At the beginning of 2020, the research was launched, and through more than 2 years of hard work, a lot of experience has been accumulated from project preparation to the official landing of electronic information. In the context of the epidemic, electronic information has become one of the necessary components of clinical trials, and the traditional way of knowing has certain limitations, from the traditional to the electronic way, it seems simple, but it took more than 2 years to complete this process, during which the restrictions of laws and regulations were clarified through the cooperation of various departments (such as the Personal Information Protection Law, the Electronic Signature Law, the Guidelines for the Management of Drug Clinical Trials during the New Coronary Pneumonia Epidemic, etc.), and at the same time actively collected the questions and feedback of the teachers of the institution, and strengthened the cooperation with the first According to the collected user feedback, more than half of the institutional users reported that electronic has reduced time and can effectively help patients understand and know, and in the longer run, the promotion of econsent, i) improve the subject's understanding of the informed, but also reduce the risk of patients being out of the group due to poor informed understanding in the follow-up clinical trialsand ii) for some clinical trials that require re-consent for a long time, eConsent gives participants an additional way to opt-in to sign informed; iii) The introduction of the system can more effectively help institutions manage the version of the informed signature to ensure consistency.
Benefit analysis. It gives patients an additional option to sign and know, reduces the time required for traditional knowing, helps patients understand and knows, and facilitates the management and preservation of informed documents by institutional teachers.
Sumitomo Pharmaceutical's DCT practice case
DCT is a decentralized clinical trial (DCT) solution that applies 100% remote follow-up of subjects in a phase 3 clinical trial program
Project Leader: Xie Ping, Head of Clinical Operations at Sumitomo.
Background. This case is a phase III clinical study in China, and the primary and secondary efficacy endpoints are subjective efficacy indicators of the subjects, and all efficacy data and oral medication data are self-reported by the subjects. Based on this study design, the traditional methods often face problems such as difficulty in subject recruitment, high dropout rate, poor compliance with log records, timeliness and accuracy of data collection, poor data quality, etc., and the patient population in this study is older, so the understanding of log filling requirements needs more guidance, compliance is more challenging, and the risk of dropout is high.
Sumitomo Pharma Solutions.
The hybrid remote DCT mode was adopted, in which all subjects used ECO to record efficacy indicators and medication data, and the traditional form of visit was combined with DCT tools such as remote informed, remote follow-up, direct drug delivery to patients, electronic payment, remote monitoring and remote recruitment, so as to achieve subjective data collection and patient-centered flexible trial implementation plan.
Benefit. The DCT platform is used to realize the timely collection of subjective data and the timely detection of problems, remind the subjects and guide the subjects to correct in time, so that the compliance and data quality of the subjects can be improved; The use of remote visits and direct drug delivery to patients enables subjects to flexibly arrange their lives while participating in clinical research according to the protocol, the main protocol violations are reduced, and the dropout rate is better controlled. Enrollment is faster.
In summary, the DCT hybrid model has a higher degree of subject cooperation and better data completion, which is a better presentation form of patient-centered clinical research.
Takeda DCT Practice Case
Application Exploration of Wearable Device Capture Digital Endpoints
Project Leader: Jieru He, Deputy Director of R&D Digital Strategy, Takeda Asia Pacific.
Background. This case study aims to verify the feasibility and usability of wearable devices to remotely collect patient data in a clinical setting in China. The aim of the project is to explore the technical feasibility of wearable devices in China and the availability of subjects, paving the way for future digital endpoints using DHT capture in China.
Project Overview. Takeda is a leading global pharmaceutical company committed to driving innovative clinical trial approaches to improve research efficiency and patient engagement. In China, Takeda decided to conduct a DCT validation program to evaluate the feasibility of wearable devices and remote visits in a clinical setting in China.
Project Objectives. Evaluate the technical feasibility of wearable devices (data transmission, etc.) in the clinical setting in China
Study participants' acceptance and usability of wearable devices (patient compliance).
To explore whether patients are able to complete the DCT elements of the study design at home, such as patient self-report data, remote data collection and remote visits by devices, patient support with Call Centre, and dtp DFP delivery and ** equipment.
Assess compliance with patient safety and privacy data protection throughout the process.
Project implementation. Takeda worked with partners to select a group of healthy subjects who met the study criteria as trial subjects. These patients were equipped with wearable devices to collect various physiological data, movement patterns, sleep patterns, and other data for exploratory validation of digital endpoints for future study designs. At the same time, through the DCT platform and remote visit tools, researchers can communicate and evaluate patients in real time.
Expected results. The technical feasibility of wearable devices in the clinical environment in China has been verified, and the accuracy and stability of the data have been confirmed.
Participants had a high level of acceptance of wearable devices, and the majority of patients were able to wear and use the devices correctly.
The feasibility of patients completing the DCT elements of the study design at home was confirmed, with high adherence and good results from remote data collection and remote visits.
The data transmission and data protection measures for the device are effectively implemented to ensure the security and privacy of the data.
Roche DCT in practice
Trial Drug Direct and ** (DTP).
Project Leader: Roche Global Drug Development China Center.
Peng Jian, Team Director of Clinical Research Operations.
Summary. The geographical distribution of clinical trial subjects in China is widespread, some subjects are affected by diseases and have difficulty in moving, and external unexpected factors such as the epidemic are superimposed, so direct to patient is a convenient and beneficial drug management method for patients to reduce the burden of subjects.
Work something out. Transportation and time costs: Patients may face long commutes and waiting times, as well as the resulting transportation costs. DCT can reduce the cost of transportation and time for patients, and improve the convenience and comfort of their participation in research.
Patient diversity: Traditional clinical studies may not be able to cover a sufficiently diverse patient population, as some patients are unable to reach the study site due to geographic location, transportation issues, or physical discomfort. DCT can expand the range of patients, thereby increasing patient diversity and improving the representativeness and applicability of research results.
Case innovation and features.
Serve patients directly, better meet patient needs, and ensure the integrity of clinical trial data.
Case Description. The direct to patient module has a mature operating system in Roche, and the company has a clear process and supervision for the qualification evaluation and operation management of the company. As of January 2024, the module has successfully shipped 1,060 drug orders, covering 178 different cities, involving 43 clinical projects in different fields such as solid tumors, hematological tumors, and immunology.
The use of the DTP module makes it possible to deliver drugs directly to patients, providing patients with more convenient and efficient medication services.
Cooperation case. As of January 2024, 1,060 drug orders have been delivered directly using DTP, covering 178 different cities, involving 43 clinical projects in different fields such as solid tumors, hematological tumors, and immunity.
Benefit analysis. The direct-to-patient benefit analysis can be considered in a number of ways:
1. Patient convenience: direct delivery of drugs to patients can provide a more convenient way of medication, avoiding the time and energy cost of patients going to pharmacies or medical institutions. This can improve patient compliance and reduce the risk of missed or incorrect medications, which can lead to improved outcomes.
2. Patient retention: Direct delivery of drugs to patients can improve the patient retention rate of clinical research projects. By delivering the study drug directly to the patient's home, the difficulty and inconvenience of participating in the study is reduced, and their motivation and interest in participating are increased.
3. Data accuracy and completeness: The direct delivery of drugs to patients can provide more accurate and complete data. Patients receiving ** in their own daily life environment can provide a more realistic reflection of the use and effectiveness of the drug, thereby improving the accuracy and reliability of the study data.
4. Cost savings: Drugs directly reach patients to save costs for the medical system and patients. Patients don't need to pay for additional transportation and waiting times, and healthcare facilities can reduce staff and facility overhead, improving resource efficiency.
5. Diversity and representativeness: Direct delivery of drugs to patients can attract more patients from different regions, different backgrounds and different conditions to participate in the study. This increases the diversity and applicability of the findings and better reflects the real-world patient population.
It should be noted that the benefits of direct delivery of drugs to patients also need to comprehensively consider factors such as the specific study protocol, ** protocol, patient population and study design, and also need to comply with legal requirements and regulatory environment. Each project needs to evaluate and analyze the benefits according to its specific circumstances.
HCT practice case of Hikinge Pharmaceutical
A randomized, double-blind, placebo parallel-controlled, multi-center phase clinical study of the efficacy and safety of Mastofibrosis (Qi Stagnation and Blood Stasis Pattern) of Aromatic Tangerine Lactobacia Capsule**
Project Leader: Wu Jun, Clinical Project Manager of Hikinge Pharmaceutical.
Background. The project uses an electronic diary card platform to record more effectively to ensure the completion of the project and obtain high-quality results, which is well received by the sponsor.
Application scenarios. In the course of clinical trials, online electronic means are used to record the observation of subjects after medication.
Innovation & Features.
In the process of clinical trial development, we continue to improve various implementation methods, electronic diary cards effectively save costs, reduce problems such as omission and archiving of paper documents, and the means of online operation are convenient and fast.
Problem-solving.
1. Solve the drawbacks of the lack of resident CRA where the center is located, and can remotely control real-time monitoring records;
2. Solve the disadvantages of modifying paper diary cards at will;
3. Solve the problems of paper diary card archiving, omission or inconvenience.
Case introduction and cooperation cases.
In the more than one year of the implementation of the project, a total of 180 subjects in 9 centers were recorded through electronic diary cards, and problems could be monitored and solved as soon as they occurred, reducing the risk of aggravation of problems caused by untimely detection.
Through the platform of Shanghai Home Credit, all 9 centers in the project used electronic diary cards, a total of 328 subjects were screened, and a total of 180 cases were enrolled through the implementation of monitoring.
Benefit analysis. 1. For patients: improve compliance and reduce the dropout rate. The remote, convenient and mobile filling method that the electronic diary card can provide can effectively reduce the burden on patients, thereby improving the compliance of filling in the report, regularly reminding the subjects to arrive at the hospital on time, and reducing the dropout rate.
2. For the sponsor's CRO: reduce costs and improve efficiency. The electronic diary card has the advantages of real-time data collection and easy data transcription, so it can reduce manual intervention in the data collection process and improve the work efficiency of the project team.
3. For researchers: reduce workload and obtain high-quality data. Electronic diary cards can reduce the probability of patients filling in incorrect data through system logic verification, and standardized data collection can help obtain higher quality, authentic and complete data. Relying on the natural advantages of the system, on the one hand, electronic data collection does not require manual data transcription, and on the other hand, researchers only need to carry out less data clarification, which can reduce their work burden while avoiding the problems of traditional paper entry, such as troublesome filling, error-prone data, and difficult archiving.
4. Now the State Food and Drug Control Bureau is paying more and more attention to the controlled management of paper documents, and the use of electronic diary cards is also more advocated, which is easier to accept during on-site inspection, so as to avoid some items using diary cards to collect the main efficacy indicators, and modify or replace them at will.
HCT practice case of Hikinge Pharmaceutical
A Phase II Dose-Finding Clinical Study to Evaluate the Efficacy and Safety of Anemia in Oral SSS17 Capsules** in Non-Dialysis Subjects With Chronic Kidney Disease
Project Leader: Liu Yuan, Clinical Project Manager of Hikinge Pharmaceutical.
Background. In the process of project implementation, some hospitals involved are unable to directly pay the subject's expenses, and through the Susuo platform, the subjects can upload supporting electronic documents such as medical records, drug purchase details and invoices, and complete the reimbursement and compensation of expenses in a short time. For the oral SSS17 capsule project, a total of 11 subjects from 4 centers were screened, and the subjects who were successfully screened were reimbursed after uploading information using the Susu platform.
Innovation & Features.
Because the hospital process will not change easily, it has derived an assistance platform, which is a good way to help solve the problem of cumbersome and long payment process cycle, and better allow subjects to benefit from reimbursement as soon as possible, so as to generate greater trust in the project trial drug and trial process.
Problem-solving.
1. Solve the problem that some hospitals cannot directly pay the cost of the subject;
2. Solve the problems of the long process cycle of some hospitals paying the subjects and the negative emotions of the subjects.
Benefit. 1. The platform is simple and easy to use;
2. You can directly upload the electronic version of the information, and there is no need to mail the paper materials separately to support it;
3. The reimbursement content is clear, and there is no false or duplicate reimbursement;
4. The reimbursement speed is fast and the cycle time is short, which greatly brings convenience to the subjects.
IQVIA DCT in practice
Technology-enabled non-interventional prospective observational follow-up study in China
A groundbreaking decentralized clinical trial (DCT) solution for out-of-hospital enrollment of subjects
Project Leader: Ma Yan, Head of DCT at IQVIA.
Application scenarios. Technology enables non-interventional prospective observational follow-up studies in China, where there is limited data on the efficacy and safety of specific over-the-counter drugs in China, and regulators have doubts about their potential safety risks, and more data support is needed. This study solves the problem of traditional in-hospital recruitment difficulties through a pioneering out-of-hospital recruitment model to improve recruitment efficiency.
Project Introduction. According to the characteristics of over-the-counter drugs, the project adopts a single research center plus out-of-hospital recruitment model, and uses tools such as electronic information, remote data collection and electronic payment to accelerate the recruitment of subjects, reduce the operational burden and improve research efficiency.
Using a single research center combined with the model of out-of-hospital recruitment, remote informed consent is realized through electronic information, and eligibility judgment is quickly made through the DCT platform to accelerate the enrollment speed. Collect data remotely with electronic questionnaires and scheduled reminders, eliminating the need for coordinator transcription and auditor monitoring, reducing data management costs. Through electronic payment tools, speed up the payment of subject compensation fees and improve subject compliance. The program has been successfully applied to the research of over-the-counter drugs, and has been successful in broadening the recruitment channels through out-of-hospital recruitment.
Problem-solving.
Problems such as poor traditional in-hospital recruitment, limited data on over-the-counter drugs, poor participant experience, high dropout rate, and high research costs.
Innovation & Features.
The comprehensive application of out-of-hospital recruitment mode, electronic knowledge, remote data collection, electronic payment and other tools can reduce operational burden, improve research efficiency, and subject-centered intelligent recruitment and management.
Benefit analysis. The cost of research has been significantly reduced, only 1 research center + out-of-hospital recruitment is required, and there is no CRC transcription and CRA monitoring, which reduces the cost of data management. Subject-centered, 100% remote recruitment and follow-up, remote data collection, and electronic informed consent reduce the burden of subjects and improve subject compliance.
IQVIA DCT in practice
Technology empowers prospective long-term follow-up research in China
Decentralized clinical trial (DCT) solution with 100% remote follow-up of subjects
Project Leader: Ma Yan, Head of DCT at IQVIA.
Application scenarios. Technology empowers prospective long-term follow-up studies in China, observational studies in which specific subjects are scattered in different institutions, without drug intervention, and all data are self-reported by subjects.
Case Introduction. This project adopts a 100% remote DCT model, combined with remote information, follow-up, electronic questionnaires and electronic payment tools, to solve the problems of difficult subject recruitment, high dropout rate, difficult data collection and poor quality in traditional observational studies. Through intelligent remote data collection, the enrollment speed is improved, the drop-off rate and screening failure rate are reduced, the research cost is greatly reduced, and the efficient operation of long-term tracking is realized.
Through the 100% remote DCT model proposed by IQVIA, combined with remote informed, follow-up, electronic questionnaires and payment tools, remote data collection of specific subjects can be realized. The number of research centers has been greatly reduced, which greatly improves operational efficiency and makes the entire research process more intelligent and efficient.
This protocol has been successfully applied to a long-term follow-up study of more than 200 specific subjects, with significant acceleration of recruitment, improved subject compliance, 85% reduction in dropout rate, and 93% reduction in screening failure rate, which has achieved remarkable success.
Problem-solving.
Problems such as difficulty in subject recruitment, high dropout rate, poor follow-up compliance, difficulty in data collection, poor data quality, high operating costs, and scattered data in different institutions.
Innovation & Features.
The remote DCT mode, intelligent remote information, follow-up, questionnaires and payment tools can make enrollment faster, significantly reduce the drop-out rate and screening failure rate, greatly reduce the research cost, reduce the number of research centers and the number of on-site monitoring.
Benefit analysis. The number of research centers has been reduced by 85%, the number of on-site inspections has been reduced by 96%, and the research budget has been reduced by 30%, demonstrating the significant benefits of the remote data acquisition intelligent solution in optimizing research efficiency and reducing costs.
Susu Technology DCT practice case
Care Center's patient retention services enable Phase III registrational clinical studies
Decentralized clinical trial (DCT) solution with 100% remote follow-up of subjects
Project Leader: Zhao Zhifei, head of operation of Susu Technology.
Background. In this case, the electronic log is the only way and tool to collect the main efficacy evaluation data, the amount of log data is very large, and the subjects are mostly elderly, and the compliance of the subjects is very important to fill in the electronic log correctly.
Based on this study design, traditional methods often face difficulties: there are many research centers, and the acceptance and operation of electronic logs among subjects in different regions are different, and it is difficult for subjects to manage, communicate and coordinate with them, and it is difficult to collect data; The elderly group is not easy to understand the requirements of electronic log operation, has a high error rate of electronic log data, does not fill in the log in time, has poor data quality, is prone to fear and impatience, and has a high risk of falling out. The amount of log data is very large, and CRC lacks a dedicated time to track the progress of the data, and cannot detect data problems in time, resulting in a high risk of invalid evaluation of efficacy data.
Susu Technology Solutions.
The client adopts a subject-centered Care Center service plan:
1.The care center has a full-time person to provide standardized service support to multiple centers.
2.Understand the living habits of subjects in an all-round way and construct subject portraits;
3.Provide humanistic care + psychological counseling for subjects with warmth, and companionship is more important than tracking;
4.Provide accurate problem teaching in real time according to the current situation of subject log filling;
5.Strengthen the link between the family members of the subjects in a timely manner;
6.View log data in real time to ensure that log problems are detected at the first time.
7.Combined with the subject's past habits, abnormal data were screened;
8.Communicate with subjects in real time for abnormal data, understand the real behavior changes behind abnormal data, and find evidence support for abnormal data;
9.The situation of the subjects will be reported to the project team on the same day, and the problems will be solved on the same day to ensure that the collection of log data meets the requirements of the program within the specified time;
10.Regular problem review and multi-dimensional data support.
Customer benefits. The Care Center significantly improved the compliance of subjects and reduced the dropout rate and PD rate of subjects.
1.Everything is subject-centered, all-round link of subjects and their families, the first time to understand the dynamics of the subject's behavior, to minimize the risk of shedding;
2.Care Center decentralizes and integrates operations, with highly unified implementation standards, reduces data collection bias caused by multi-center regional differences, and effectively avoids the risk of management chaos of distributed operations.
3.Detect log problems at the first time, conduct targeted education in a timely manner, and fundamentally improve data quality.
4.Real-time dynamic attention to log data, timely detection of abnormalities, real-time communication, to provide evidence support for abnormal data combined with subject behavior dynamics;
5.The sponsor can monitor abnormal data through multi-dimensional trend charts to ensure that there is a basis for decision-making, a standard for implementation, and a means for supervision.
A practical case of DCT in the cloud
ECO technology enables real-world research on rheumatoid arthritis (RA) patients in China
Decentralized clinical trial (DCT) solution for remote follow-up of subjects
Project Leader: Zhang Zhiwei, Director of Yilin Cloud Medical ** Camp.
Background. This case is a long-term follow-up trial, with a large number of subjects, reaching tens of thousands, with the purpose of observing the efficacy and safety of subjects within a specific period of time after medication. Based on this study design, traditional methods often face problems such as difficulty in subject management, poor subject compliance, poor data quality, and paper data is not easy to preserve. In addition, this case requires the recruitment of a specific population of subjects, and the subjects are scattered in different research institutions, resulting in high operating costs and difficult data collection.
One pro cloud solution.
All subjects were used to fill in the data using the ECO system, and the information was collected by filling in the scale and log by mobile phone, and at the same time, medication filling reminders were set, and functions such as medical support and trajectory inspection were configured to achieve remote data collection and facilitate long-term follow-up.
Customer benefits. Higher subject compliance, better data accuracy and completion: through multi-dimensional medication reminder setting and electronic data collection, the operation is convenient, and the subject's medication and form filling compliance is higher, which improves the timely and effective data.
All-round efficiency improvement: Compared with paper filling, electronic scales can avoid filling in format errors and omissions, save manual transcription time, make it easier to trace the source, and reduce data errors.
All-round cost reduction and efficiency increase: Data collection for remote monitoring reduces the number of clinical monitors visiting the research center and saves research costs.