|
|
|
International Clinical Trials
|
For many patients across a wide range of therapeutic areas, participation in a clinical trial can provide access to important life-saving medications. However, the efficient conduct of studies has long been complicated by complex protocols, inefficient recruiting methods and logistics that can make participation burdensome, if not impossible. Consequently, numerous trial sponsors, CROs, and clinical services companies are striving to facilitate patient access to studies while also making the trials themselves more patient-centric. In addition to improving recruitment processes and easing the burden of participation, such efforts are largely designed to enhance patient engagement before, during, and after the study.
While the challenges surrounding patient access, retention, and engagement are not new, surmounting these requires new approaches to trial design and administration. Already, some sponsors and CROs are incorporating patient input into study design to align clinical endpoints with patients’ priorities for health outcomes. On the legislative front, citizens and lawmakers in several US states are seeking to pass ‘right to try’ laws intended to enhance access to experimental drugs, especially for terminally ill patients. Nonetheless, such initiatives will not be sufficient unless they are accompanied by efforts that improve the patient experience.
Transportation Resolutions Historically, transportation costs have constituted a very small portion of clinical trial expenses. However, when patients lack reliable transportation, this can lead to noshows and dropouts, which significantly impact study costs and results (1). A National Research Council report identified inadequate transportation as a major contributor to a 30% dropout rate in Phase 3 trials, noting that the problem worsened over the course of lengthy trials (1,2). Factors such as travel distance and intensive trial-related testing schedules are often cited as barriers to participation, especially among patients considered for lengthier trials and the elderly, as well as for those with challenging disease profiles for whom transportation can be very difficult (3).
|
Read full article from PDF >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
News and Press Releases |
 |
BioIVT to Focus on the Application of In Vitro Hepatocyte Models in Toxicology Research at the North American ISSX Meeting
BioIVT, a leading
provider of research models and services for drug development, today announced
that it will be participating in several sessions at the 22nd North
American International Society for the Study of Xenobiotics (ISSX) Meeting.
This conference will be held from July 15-19 at the Palais des congrès de
Montréal in Montréal, Canada.
More info >> |
|
 |
White Papers |
 |
|
Conveying Medical Guidance in Clinical Trials – A Survey
Europital Medical Consultancy
With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project.
When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
More info >> |
|
 |
Industry Events |
 |
SAPHEX 2018
1-2 November 2018, Gallagher Convention Centre, Midrand, South Africa
The SAPHEX exhibition and conference is now established as the “go-to”
networking and business event for anyone working in the South African
pharmaceutical manufacturing industry.
More info >> |
|
|
