Clinical trials data collection

Clinical Trial Data Collection Systems Clinical Trial Review Tools Inventory System Electronic Publishing Regulatory Submissions... 

While using software that can facilitate cleaner data faster just seems to make sense, the following list has some of the reasons why EDC has yet to replace the paper-based clinical trial data collection process ... 

With the increased acceptance of the Internet and the huge innovations in web development tools, web-based data collection and management systems have become the choice of many CROs because of their capability for collecting clinical trial data in real time and disseminating critical clinical trial information to the participating sites and various oversight committees [27]. 

CHMP (2005) Guidance on Data Monitoring Committees/ FDA (2006) Establishment and Operation of Clinical Trial Data Monitoring Committees These documents provided guidance on the set up, operational and working procedures, and the roles and responsibilities of the DMC in a single clinical trial or collection of trials (see Section 14.4). 

Even a modest new drug application will require a substantial investment of money and time. The financial expenditure includes the outlay for clinical trials to collect the data and to assemble the application. Time is also a crucial variable, because the only way to justify the expenditure is through sales of the product, making the remaining patent life an important variable in such a decision. If it is short, then the patent may expire before the new drug application can be assembled, submitted, and reviewed to receive labeling for that indication. 

Clinical Trials Data Bank We have established a clinical trials data bank to collect information on your clinical trials protocols. Please list your protocols for serious and life-threatening conditions [Food and Drug Administration Modernization Act of 1997 section 113]. When finalized, you should list your protocols in accordance with our Draft Guidance for Industry—Information Program on Clinical Trials for Serious or Life-Threatening Diseases Implementation Plan, June 2001. 

Systems audits in this late phase in clinical trials aim at assessing related procedures to ensure that capable procedures exist for managing and cleaning clinical trial data, for conducting statistical analyses and for preparing the final study report which represents properly the data collected and reported in the clinical trial. Such systems audits are performed across functional boundaries. Such systems audit can be combined with a database audit and/or an audit of the final study report. 

The terms electronic data capture (EDC) and remote data collection (RDC) are generally used as synonymous in describing the technology-based collection of clinical trial data from physicians participating as investigators in a clinical trial. These are web-based (online), client server (off-line), or hybrid (combined on-line/off-line) software applications. And there are implications to be considered when choosing an on-line, off-line and/or hybrid solution. However, ING Barrings differentiates RDC from EDC. 

To calculate QALY, we need to estimate the life years of the patient population based on clinical trial data and the health states and their durations during the life years. Health states are usually related to the study endpoints, for example, disease progression or deaths. Multistate analysis can be used to make these estimates. Once the health states are determined, the value or QoL (Q) associated with each state can be established using expert opinion, QoL data collected in the clinical studies, or direct or indirect research. The most frequently used method in practice is direct or indirect research by way of preference survey of health providers and patients. Time trade-off, standard gamble, and rating scale are among the ways to assess the preference of specific health state. As an alternative, indirect research uses questionnaires for health state in several health domains or attributes (e.g., EQ5D) and then to construct a multiattribute utility as a summary measure that reflects preferences both within and across health domains. 

Value attributes will need to be collected, measured, aggregated and converted to evaluate a value metric (Deloitte, 2012). The data that will feed into this assessment will need to go beyond purely clinical trial data. Real-world data - that is, data relevant to the drug in use, not just in trials - would apply both before the market laimch (e.g. up-to-date cost of illness data) and post-launch comparative real-world data, information on side effects and changes in effectiveness over time (Greiner, 2011). The sources of such data could transcend patients, clinicians, hospitals and social networks. The quality of the data and its format, governance and ethical considerations are likely to influence the feasibility and extent to which VBP can reflect real-world values. There may well be a need for the development of new methods which can assess value in different contexts and under different conditions, and which can incorporate trade-offs. 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

It is worthwhile to note that, in the US, where the applicant will just be dealing with a single authority, there is no need to re-submit data that was previously submitted as part of an IN D application to conduct clinical trials. Instead, the applicant can cross-reference the IND file. This does not apply in Europe, because clinical trial applications will have been submitted to individual Competent Authorities, whereas marketing authorisation applications are usually submitted either centrally to the European Medicines Agency (EMEA) or collectively to a number of Competent Authorities. Thus, the files need to be self-supporting. 

Prospective sources include encounter data, which may or may not be contained in EHRs patient data input and randomized, prospective clinical trials. Advantages of prospective sources to inform interactive software include the ability to control and monitor the circumstances of data collection reduction (as a result of randomization) of sources of bias potential minimization of missing data potential to modify design of data collection ability to verify data accuracy and ability to validate and further test assumptions and modify existing programs. 

Data collection in clinical trials consists of the processes of collecting reliable clinical, control, and administrative data from the trial s participating sites... 

In clinical trials that solely or partially rely on paper forms and pure paper-based data collection systems, participating sites use a mail carrier to send batches of hard copies of completed forms to the coordinating center. With this approach to data, forms and computer programs are necessary to keep track of received batches of completed forms. 

Until recently, pure paper-based data collection systems have predominated in clinical trials. However, they are still being used by many contract research organizations (CROs) either because of financial constraints that prevent them from investing in newer technology or because they deal with small clinical trials that do not justify that investment. Other CROs consider the paper-based data collection method to be the safest and most reliable approach to data collection. 

Electronic-based data collection and management systems use various computer hardware and software technologies. Although some organizations design and develop their own systems, others purchase well-established e-clinical trials software from a wide range of vendors. 

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