Clinical trials are a set of procedures in medical research conducted to allow safety. Site Initiation Visit by Sponsor verifies that Investigator & his Team are. Start studying Investigator Meetings and Site Initiation Visits. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Rehearsal for Site Initiation Visit. Rehearsals for individual CRAs are important -Ensure consistency. Clinical Trial Study Team Functions. Clinical Research Associate. Assessing Practices & Inefficiencies with Site Selection, Study Start-Up, and Site Activation. With more than 3,000 active global clinical trials conducted annually at approximately 40,000 investigative sites dispersed worldwide. And training is then provided on a site initiation visit (SIV). Monitoring The act of overseeing the progress of a clinical trial, and of ensuring that it is: conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Trial monitoring is an Integral Component of trial quality assurance.
Sponsor and contract research organization (CRO) companies conducting global clinical trials face numerous operational and logistical challenges. With more than 3,000 active global clinical trials conducted annually at approximately 40,000 investigative sites dispersed worldwide, companies are looking for more efficient ways to streamline their processes in order to speed up timelines. 1 A number of factors impact study cycle times, including protocol amendments and patient recruitment and enrollment challenges. Tufts Center for the Study of Drug Development (CSDD) research found that substantial amendment presence in a protocol significantly increases study cycle times.
Protocols with at least one substantial amendment had a study duration of three months on average longer than those protocols lacking substantial amendments. 2 In addition, research reveals a high turnover rate among investigators conducting trials, with about 40% each year choosing not to conduct any further trials, citing regulatory compliance burden and a challenging operating environment. 1 Recruitment challenges are typical, and findings from a recent study among examining 151 global clinical trials from 12 companies indicated that 11% of sites failed to enroll a single patient.
3 Companies are also looking to increase efficiencies as they face more complex study protocols in therapeutic areas such as oncology (with the use of targeted therapies) and neuroscience (diseases such as Parkinson’s and Alzheimer’s). Prior research examining protocol complexity and burden on clinical site staff found that the investigative site work-effort to administer each protocol had increased 64% between 2002 and 2012.
Activities associated with site selection, study start-up, and site activation also pose challenges and company practices contribute to inefficiencies in these areas. There are hurdles within the regulatory environment, and timelines for site contracting, budget negotiations, and submissions. 6 Organizations are continually looking to improve their study start-up cycle times through investments in technology, including data analytics and other software. These processes can potentially be streamlined through electronic cloud-based solutions, online clinical document exchange portals, and shared investigator databases. 7,8 Tufts CSDD research suggests that the early stages of the site initiation process accounted for the majority of cycle time and the highest variance (the pre-study visit to contract execution), while little variation was observed at the end of the process (contract execution to first patient in) across therapeutic area, type of site, and geographic region. 8 In examining over 100 global clinical studies by therapeutic area, Tufts CSDD found that oncology and central nervous system therapeutic areas represented the longest cycle times to first patient in, while cardiovascular, infectious disease, and metabolic and endocrine studies had significantly shorter times to first patient in. 8 In addition, academic institutions and government-funded sites took longest to first patient in, while physician practices were fastest.
In a further analysis by global regions, sites in Latin American took twice as long as sites in North American to enroll the first patient. 8 Study start-up is similarly viewed by investigative site staff as an inconsistent and inefficient process. Over 200 clinical research professionals who responded to a survey identified certain key areas that could be improved upon including contract and budget negotiations, regulatory processes, document management and communication between sponsors and sites.
![Site Site](http://www.natap.org/2017/images/102417/102417-2/1024171.gif)
9 Based on the previous research on benchmarking clinical trial initiations and the wide variation and inconsistency among organizations, Tufts CSDD conducted a follow-up study examining practices and inefficiencies in site selection, study start and site activation. In-depth interviews were conducted with senior level pharmaceutical and CRO executives to better understand the challenges and overall strategies that organizations are using to improve these activities. The study was funded by goBalto, a technology solutions company. A total of 26 interviews were conducted across 21 companies. In some cases, more than one representative from a company was interviewed across functions to gather more complete information and better understand the approaches for activities associated with site selection through site activation. Respondents represented 13 biopharmaceutical companies and eight CROs across 13 large and eight mid-sized and small organizations.
Interviewees were experienced and were primarily senior level executives occupying director level roles or above. A few respondents held newly created roles within separate study start up functions (see chart 1). Interviews examined the key criteria utilized to qualify and identify investigative sites and how practices vary across organizations.
Use of repeat sites, experience level of sites, and therapeutic expertise were factors investigated. In addition, novel practices adopted by companies and any solutions currently being planned and implemented were identified. Use of performance indicators, including historical site data, and perceived or measured impact on cycle times and cost were also explored. Last, respondents reported the greatest challenges to study start up, site selection and activation and resources or investments that have improved these areas. Site qualification and identification The results suggest that sites are primarily identified based on therapeutic expertise, phase of research, and by global region. Respondents reported that the most critical factors are an organization’s previous experience with a site, site experience, performance, and capabilities, including sufficient staff and resources to conduct a study. One respondent from a large pharmaceutical company discussed, “If it’s an area we know well, we go to sites we know.
Site Initiation Visit Report
We use benchmarking data to help teams and affiliates. We get a download of all investigators in indications (globally) and rank them.
Site Initiation Visit Slides
We also do a therapeutic area scan and by country. We ask how active investigators are in the trial landscape. We take a list of top 10 investigators in the field.” Another respondent from a small biopharmaceutical company noted that “we are a hybrid house. We outsource some of our trials and some we run ourselves. Outside the U.S. We don’t have boots on the ground; we work with a CRO partner.” Global expertise becomes important, as there is regional variation in cycle times to first patient in.
Pre Study Site Visit Clinical Trials
These data reflect similarities to the findings of an earlier Tufts CSDD study that found sites in Latin America and Eastern Europe had longer cycle times than sites in other regions, and North American sites took the least amount of time to first patient in (chart 2). Through feasibility studies, organizations are able to discern a site’s ability to execute the proposed study and complexity of the protocol. A detailed on-site assessment was conducted in some cases. Past experience with a site is a strong indicator and is guided by intelligence gathered both internally and externally. Large companies tend to have more consistent and strategic approaches to gathering central and local intelligence on sites, and follow global processes. Sources used included CiteLine or TrialTrove and intelligence gathered by site management organizations (SMOs) or CROs.