International Clinical Trials, Essay Example

Question1: Identify and describe the 3 different means to evaluate on-site study conduct. Include the responsible party and driver of each means. How are these means complicated by including both domestic and foreign trial sites, if at all?

Three different means to evaluate on-site study conduct are through Routine Monitoring visits. Second is by utilizing an audit plan and thirdly instituting regulatory inspections. Routine monitoring visits have distinct phases. They encompass scheduling milestones, conducting site initiation and executing the routine monitoring. However, before the process begins structural issues must be resolved. They involve obtaining as well as sustaining confidentiality. Besides, responsible parties such as investigators must ensure that health care personnel are not so immersed in the monitoring process at the expense of delivery functions. Local personnel involvement is desirable, but must be carefully monitored.

The Audit plan protocol requires that the Quality Affairs Group draft the audit plan specifications. They are usually assisted by the Trial Manager. Key factors that must always be considered when designing audit plan are the number of sites to be visited, countries in the global perspective, site experiences, and duration of the trial and how complex is the protocol. Results of audits are usually ready within 30 days after which a report and certificate is tendered to responsible parties.

Regulatory inspections are globally as well as being locally conducted, but have serious challenges due to the extent of these inspections. FDA on many occasions becomes the responsible party initiating them and designing the protocols too. FDA is very concerned about clinical trials being conducted overseas, especially, in developing countries. Often they are not in compliance with regulations applicable for execution. Therefore, regulatory inspections are very important to ensure there is global as well as local trial compliance.

While cross-center clinical investigators, sponsors and IRBs guidelines were established still it becomes very difficult to conduct global inspection due to lack of data when inspectors review trials. There is immense difficulty in evaluating validity of trails conducted in foreign centuries. Apart from compliance irregularities there is very limited supporting data pertaining to subject screening or criteria determination for the trial itself.

Question 2: List and describe 5 unique challenges associated with a clinical trial that enrolls from both domestic and foreign trial sites. The full response should also include means to resolve these challenges.

Five unique challenges associated with clinical trials enrolling both domestic and foreign sites begin with the first being difficulty with maintaining the same level of human protection of subjects between international trails and domestic ones. This occurs because FDA gets very little data pertaining tto how domestic and international trials function from institutional review boards. Boards are not inspected with respect to how they function. The excuse is that they do not receive data from most countries regarding the trials they conduct. If they do get any data they are often limited and irrelevant.

The second unique challenge relates to institutional boards of individual countries. They do not comply with data collection and dissemination protocols. Therefore, FDA cannot guarantee foreign investigators confirmation that they will ensure human subjects’ protections. Besides, databases used for storing subjects’ trial information are inadequately kept in foreign sites. There is no data concerning entities conducting research and measures used to in their conduct. This is a very serious omission in the execution of research science. Strong penalties should be imposed for non compliance. Encouraging compliance through education regarding the importance of keeping accurate data is recommended.

A third unique challenge pertains to ethical and policy issues between the domestic and foreign sites. For example, it was discovered that increasingly more foreign countries are using scientists as collaborators of research comparatively conducted in United States of America. These researchers while equally qualified find it challenging confirming to international protocols’ established by organizations such as FDA.

Consequently in making cultural adaptations to their particular landscape they are seeking justification from international authorities to do so because the policies and ethics may be incompatible with their unique cultural paradigms. Consequently, it is important that some cultural competence be established in the conduct of trials internationally for ethics and policy appropriateness domestically as well as internationally.

Inspection difficulties are a fourth unique challenge experienced when conducting both foreign and domestic trials. It would appear that locally more inspectors are available to conduct monitoring, audits and regulatory inspections. Reaching all the foreign countries involved in the same domestic trial is often imposiible. As such, fewer inspections are conducted. In somes cases there are not enough inspectors/investigators to do the job. Subsequently, the fifth and final unique challenge in inadequate monitoring of trials both domestically and internationally emerges. Unless there is adequate funding some sites will not be mointored due to lack resources. Reducing the number of sites within a trial and increasing funding are favorable resolutions.

Question 3: Explain the purpose of clinical trial registration and submission of trial results from perspective of global trial (both domestic and foreign trial sites). In addition, list the parties (stakeholders) that benefit and provide explanation as to why this would be considered a benefit. 

The purpose of registering a clinical trial and submitting results is due to the benefits that can be derived from the process. Therefore, details regarding the time of commencement along with subsequent updates, providing summaries and distribution of results to the appropriate sources is essential to scientific development. One main purpose is its ethical relevance since registering and submitting data helps other scientists to understand the value foundations of the study. It exposes virtues as well as limitations in applying results to evidence-based practices. Importantly, a clinical trial registry prevents publication biases. Registering and providing results also assist International Review boards in sanctioning clinical trial results use in medical science or pharmacology wherever applicable. Essentially, based on the International Review Boards’ evaluation of data presented more appropriate distribution of research funds is facilitated.

Stakeholders/parties that benefit from the registration process and results of trials include first subjects themselves involved in the study. They are often paid for participating along with receiving free medical assessments for the particular disease being researched at the time. The generalpublic benefits because more authentic information on medical issues or drugs is filtered to the public, which can either, take precautionary measures or embrace the new discovery. Clinicians benefit by receiving access to modern developments in their expertise, which can be applied as evidence-based practice interventions.

Healthcare as a system benefits immensely through improvement in quality and availability of services and interventions. Specific improvements in infrastructure with respect to care processes and workforce adaptations are identifiable benefits of clinical trials use in healthcare delivery practices. Further, Infrastructural benefits can be described as characteristics of healthcare setting directly related to the quality of care delivered in the institution. Trails use infrastructure for execution.

These same infrastructures if the trials pertain to a healthcare phenomenon can be beneficial to a comparable healthcare setting. Importantly, even though, the infrastructure was one utilized for research-related procedures, the potential always exists that after completion it remains. As such, this acts as an as an evidence-based model that is applicable. This is how registration and submitting results along with follow up data benefits many stakeholders/parties because a record of exactly how the trial was conducted is available.

Journal editors and users of medical literature are other parties/ stakeholders that benefit from clinical research. These experts utilize clinical trials’ data in conducting meta-analysies, which can only use clinical trials as the research methodology. Systemic reviewers also utilize data from randomized controlled trials in their research projects..