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Problems that occur while Data Sharing in Current Time.
The current mindset that all data, automated or otherwise, is proprietary and its exchange could prove competitively disadvantageous is a hindrance. Apparently, some data is proprietary but more data should be shared to mitigate the complexity and rising costs of clinical trials, prompting sponsors to run more efficient clinical trials with faster enrollments. These outcomes will lead to enhanced medical research and development, bringing new therapies and treatments to the market faster. An intelligent Clinical Data Management System (CDMS) shall prove beneficial for scientists who look forward to interacting with the data, rather than just collect, organize and integrate them. Conclusion A data system is required that allows free flow of data, connects patients, monitors, researchers, data managers, CROs, and sponsors, ensuring best clinical decision making in real-time. It will also lead to quantitative analysis of data and data-driven decision-making. It will automated information exchange and ensure elevating clinical trials to new levels. Standardization and automation of clinical data will make it more easily accessible and usable, and shareable. Automation in Clinical Data Management shall push the boundaries of what can be achieved in the clinical research industry. A new and advanced approach to data collection, management, integration, and analysis shall enable data exchange, prompting researchers, sponsors, and medical professionals to make fast evidenced-based decisions. Data sharing has made it possible to quickly determine the safety and efficacy of new drugs and treatments for different patient populations.
Principles regulating clinical trials worldwide
Clinical research training Clinical research training programs are designed for clinicians and scientists around the world. These research training programs provide advanced training in healthcare methods and research. The training often incorporates in-person seminars and dynamic workshops. It focuses on enhancing clinicians’ and staff skills, knowledge, and ability at every phase of the research, particularly for pre-clinical research phases. The training includes writing grant proposals and launching new projects for analyzing data and presenting their clinical results. . Take the Best Training in Clinical Research. Principles regulating clinical trials worldwide Clinical trials are required to follow the following guidelines and more to ensure the safety of patients and efficacy of tests and treatments. However, stringent requirements may force clinical trials to shift to low-income and middle-income countries depriving the local population of the opportunity to benefit from international clinical research. ● Obtaining clear, transparent, and informed consent from participants. ● Allowing participants to withdraw at any point of time from a clinical trial. ● The outcome of the clinical research should provide benefits to society without doing any harm to the participants who volunteered to participate in the clinical trial. ● Any unintended response to a drug or medical product should be considered an adverse reaction. ● A declaration of confirmation by the auditor that an audit has been conducted. ● The auditor should provide a written evaluation of the results of the audit. ● A written description of a clinical trial or study. ● Report of placebo or any investigational product if used in the clinical trial. ● The ethical and moral obligation to protect patients and reap clinical research benefits. . Take Clinical Research Course from the Best. The conclusions derived from the results of a clinical trial conducted worldwide generally apply to all study centers and countries. It increases the pace of drug development and facilitates the approval process of the tests and treatments in foreign markets. However, clinical trials face several challenges that they should overcome to ensure optimal conduct and coordinate clinical trial sites that operate under different regulations, technical, cultural, and political conditions. Clinical trial sponsors are responsible for obtaining consensus among clinical experts and regulatory agencies regarding fundamental questions that include a consistent diagnosis.
WHO’s International Clinical Trials Registry Platform (ICTRP)
People from more than one country and one medical or research institution can participate in a clinical trial. Different countries have different clinical research requirements, so one clinical trial may be enlisted on more than one registry. That clinical trial shall appear on the database of more than one registry. However, data on various clinical trial registries varies. . Take Clinical Research Course from the Best. The International Clinical Trials Registry Platform (ICTRP) is a global initiative by WHO, responsible for linking clinical trial registers worldwide for ensuring a single point of access and the apparent identification of clinical trials. This was done with the view that participants, patients, families, and patient groups have easy access to information. The ICTRP was established with the aim to make information about all clinical trials that involve humans publicly available. It also aims to achieve the following: ● Improving the comprehensiveness, completeness, and accuracy of registered clinical trials data; ● Communicating and raising awareness of the need for registering clinical trials; ● Ensuring the accessibility of registered data; ● Building capacity for clinical trial registration; ● Encouraging the utilization of registered data; and ● Ensuring the sustainability of the ICTRP. . Take the Best Training in Clinical Research. The Secretariat of the ICTRP is housed by the World Health Organization in its headquarters in Geneva and is responsible for the following: ● Publishes the ICTRP search portal: A database and website that makes it possible for every person in the world to search for free data provided by clinical trial registries around the world. The data is updated weekly and meets WHO’s criteria for content and quality. ● Supports the WHO registry network: A forum created to establish and work together for the purpose of clinical trial registries. It aims to establish best practices for clinical trial registration and the collection of high-quality, accurate data. ● Supports different countries and regions: It aims to establish clinical trial registries or policies on trial registration.
Clinical trial phases
Clinical trials are a type of research conducted to study new tests, treatments, and drugs and evaluate their outcomes, side effects, and efficacy on human health. There are various medical interventions, including drugs, biological products, radiological procedures, devices, behavioral treatments, surgical procedures, and preventive care in which people volunteer to take part. Take the Best Training in Clinical Research. Clinical trial phases Biomedical, clinical trials include the following four clinical research phases: ● Phase I of clinical trials usually studies new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects. ● Phase II of clinical trials studies test treatments that were found safe in phase I of clinical trials. However, phase II is conducted on a larger group of human subjects for monitoring any adverse effects. ● Phase III of clinical trials is conducted in different regions and countries and on larger populations. Phase III is the step conducted right before a new treatment or drug is approved. ● Phase IV of clinical trials is conducted after a country approves, but there is still a need for further testing efficacy in a larger population over a longer timeframe. . Take Clinical Research Course from the Best. There are various guidelines outlined by different international and national organizations for ensuring careful design, review, and completion of the process. Clinical trials require approval before they can even begin. People of all ages, including children, can volunteer to participate in clinical trials. However, various guidelines direct the participation of people in clinical trials. These guidelines can relate to underlying health conditions, side effects from other drugs, and so on.
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What is CDM? Clinical Data Management
Clinical Data Management (CDM) holds the entire life cycle of clinical data from its collection to exchange for statistical analysis in support of performing regulatory activities. It primarily focuses on data integrity and dataflow. Clinical Data Science (CDS) has expanded the scope of CDM by ensuring the data is reliable and credible. Risk-based data strategies are essential to consider as the most important component in the automation of clinical data management. Other solutions include identifying sites for clinical trials, targeting the right audience, recruiting the right patients, collecting reported outcomes, obtaining digital consent, remotely screening patients, and conducting decentralized trials. Not all data collected is useful for statistical or other analysis. There has been a steady increase in data volume; CDM can ensure which data needs to be collected to support further analysis. CDM is responsible for generating structured and unstructured data from various sources and transforming that data into useful information. Generating, integrating, and interpreting different data type new data technology strategies. Take Clinical Research Course from the Best. Sponsors have incredibly increased the use of healthcare apps and digital health technologies to collect other real-world data (RWD) and reported outcomes. Over 200 new health apps are added every day to app stores. Phase IV is most likely of all clinical trial phases to witness experiments with digital health. However, this is unfortunate since it can improve the efficacy of clinical research trials in various ways. Automation of clinical data management presents myriad possibilities for clinical research trials. Streamline clinical trial management, enhance data collection, analysis, and sharing, better matching of eligible patients with trials, and an overall improvement in experience for all stakeholders are some ways suggested and tested strategies. Still, a lot still needs to be done to enhance and maximize the benefits of automation. Take the Best Training in Clinical Research. Currently, electronic health records (EHRs) and electronic data capture (EDC) can rarely be integrated. The problems of exchange and the non-standardization of data should be solved for the clinical research industry to achieve the full potential of automated processes.
Problems Faced in Automation in CDM
Standardization of data Data should be standardized before automated sharing. It will lead to a faster collection of trial evidence and better analysis, enhanced transparency, faster start-up times, increasing the predictability of data and processes, and easier reuse of case reports across different studies. Take Clinical Research Training to understand better about on ground Problems faced by the Industry. Interoperability of EHRs for automation Although the use of EHRs has not been optimal, they have yielded great benefits at low costs and less time and presented significant possibilities for research. The collection, organization, exchange, and automation of data depends on the effective use of electronic health records (EHRs). However, EHRs have a history of poor interoperability and insufficient quality control and security of data. The way data is stored in these records often varies across institutions and organizations. Sharing the data becomes a struggle since there is no standard format for EHRs. Learn the best Clinical Research Course. Improvement in AI and automation Artificial intelligence (AI) has great potential to identify eligible patients for clinical trials. However, the reality is quite different from expectations. The major problem has been the development of sophisticated algorithms. Other barriers include the unstructured format of data and how to integrate that data into the clinical workflow of stakeholders. Clinical trial stakeholders can indefinitely benefit from a data exchange network, particularly one established between clinical trial sites and sponsors. The network would collect and analyze data before sharing it with relevant stakeholders, improving overall quality. Sponsors shall be able to share important information with sites, including draft budgets and protocol documents. At the same time, sites shall be able to update sponsors in real-time on impending matters, such as patient registrations. This would ensure an unhindered flow of information through integrated systems. However, sites should remember that not all information can flow freely and should be careful while sharing protocol-specified data with sponsors. EHRs have protected health information (PHI) and non-protocol-specific data, which would put patients’ confidential data at risk if shared.
Childhood Leukemia
Leukemia — Cancer of blood is called Leukemia. It develops in the bone marrow. Bone marrow is a soft inner part of the bone (such as thigh and hip bone) where new RBC, WBC & Platelets are formed. As we know, bone marrow also produces WBC or Leucocytes. As soon as the number of mature WBC is enough, then the body sends a signal to stop new cells’ formation. But in Leukemia, these newly formed cells stay immature for a long time. Consequently, the body cannot send any signal, so new cells form inside the bone marrow. The bone marrow becomes crowded with immature and abnormal WBC. Childhood Leukemia — Children of the age group of a newborn child to a 19-year-old. According to a study conducted in 2018, 29% of cancer in children is of childhood leukemia. The most common Leukemia in children is ALL (Acute Lymphoblastic Leukemia) and AML (Acute myeloid leukemia). Early Symptoms of Childhood Leukemia a. Dull or pale skin b. Weakness or feeling of tiredness c. Headaches and Dizziness d. Trouble in breathing e. Fever and frequent infection f. Bleeding gums or nosebleeds Types of Childhood Leukemia: Leukemia typically in kids can be categorized into two major types. A. Common types of Leukemia a. Acute lymphoblastic Leukemia (ALL), also called acute lymphocytic Leukemia is fast-growing Leukemia of lymphoid cells. This type is widespread in kids; it’s the proliferation of B and T cells lymphocyte precursor. Acute Lymphoblastic Leukemia (ALL) accounts for 75–85% of cases of childhood leukemia. b. Acute Myelogenous Leukemia (AML): AML is also a common type of childhood leukemia. This is the fast-growing Leukemia of myeloid cells. B. Rare types of Leukemia a. Hybrid or mixed-lineage Leukemia: This is chromosome-related Leukemia where part of chromosome 11 translocates to any other chromosome. Children having mixed-lineage Leukemia have a poor prognosis. b. Chronic Myelogenous Leukemia: This is slow-growing Leukemia of myeloid cells. c. Chronic lymphocytic Leukemia (CLL): CLL is very rare in children. This is the slow-growing Leukemia of lymphoid cells. d. Juvenile myelomonocytic Leukemia (JMML): This is a scarce type of childhood leukemia where WBC production in bone marrow is severely dysregulated. Diagnosis of Childhood Leukemia There are various tests to diagnose and confirm childhood leukemia. These tests also help in classifying the type of Leukemia. The initial tests include: a) Blood tests to measure the number of blood cells and see how they appear. b) Biopsy and Bone marrow aspiration test: To confirm Leukemia, a tissue sample is usually taken from the pelvic bone. c) Spinal Tap test or Lumbar puncture: This test is done to know the spread of cancer cells in the fluid (cerebrospinal fluid) present in the spinal cord or brain. These tests also determine the method of treatment to be followed. Risk factors of Childhood Leukemia More study is needed to explore the possible reasons, but few of them are environmental factors like exposure to radiation, smoking, genetic factors, inherited problems related to immune systems, etc. Treatment of Childhood Leukemia: Once the oncologist confirms the diagnosis, the child will undergo chemotherapy medicines. In highly developed countries, the cure rate for ALL (Acute lymphoblastic leukemia) is more than 80–90%, and for acute myeloid Leukemia, it is more than 60–70%. In developing countries, poor accessibility or affordability, malnutrition, poor tolerability to treatment, and delayed diagnosis bring down the cure rate to almost 70% in ALL and around 50% in AML. a) Chemotherapy: Chemotherapy uses powerful chemicals and is done to target and kill cancerous cells. Chemotherapy works throughout the body. b) Blood Transfusion: This is a process of transferring healthy blood components into a patient’s blood circulation system intravenously. This process helps in replacing red blood cells, platelets, and other blood components. c) Radiation Therapy: This is also known as Radiotherapy or RT or XRT. This therapy uses a beam of ionizing radiation to kill the cancer cells. d) Bone Marrow Transplant: BMT is performed to replace damaged or destroyed bone marrow. In this process, blood stem cells are transplanted into the circulation. Later on, these blood stem cells reach the bone marrow area to produce and promote new blood cells. Treatment of Relapsing Leukemia Despite chemotherapy, around 20% of ALL and about 40–50% of AML can come back with the disease within two to five years of initial diagnosis. This reoccurrence of infection is called relapse. Again, these children will go through a similar test like complete blood count, bone marrow evaluation to confirm the deterioration. After confirmation, they will have to undergo a higher dose of chemotherapy of a different combination or Bone Marrow Transplant. You can consult a well-experienced oncologist, or you can consult online on consultancy websites like Practo, DoctoriDuniya, etc. At DoctoriDuniya, You can book an appointment online with an oncologist or cancer specialist 24X7, with eOPd and an e-prescription facility. The cancer doctor may ask about the family history of the problem and symptoms associated with the disease. At DoctoriDuniya, you can download DoctoriDuniya — Free Medical App and create your online Personal Medical Account called NAINI. Here you can avail free follow-ups and online doctor consultation with oncologist or cancer specialist at NAINI.