Medical research is a very diverse field that involves different therapeutic strategies in order to develop new treatments for humans. Clinical trials are usually one of the final stages of medical research. These are studies used to explore whether a medical strategy, treatment or device is safe or effective (Nhlbi.nhi.gov). In this paper, I attempt to give a better aspect of clinical trials. The paper gives a clear aspect on issues concerned with clinical trials and what is meant by saying that clinical trials are going global. Furthermore, this paper tries to address different issues that have risen as a result of clinical trials going global with citation of situation that have been observed and associated with clinical trials.
According to the World Health Organization, clinical trials are any research study that assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcome (Lang and Siribaddana). From this definition, it can be deduced that trials are made of randomized interventions that involve the testing or a new drug or the standard of care treatment. Clinical trials are not solely about developing new therapies and products, but also involve providing evidence to improve the management of health issues. This involves comparison of different option rather than providing a mechanical product. For instance, clinical trials may be used to assess different types of illness management in a hospital such as different ways to enable a patient to cope better with therapy. These trials, therefore, cover a variety of medical strategies; they are not only used in drug development but also other medical strategies as long the outcome is to improve the health of patients.
What do we mean by globalization of clinical trials? To understand this, the word globalization needs to be understood. Steger defined globalisation as a multidimensional set of social processes that create, multiply, stretch and intensify worldwide social interdependencies and exchanges while at the same time fostering in people a growing awareness of deepening connections between the local and the distant (Campbell, MacKinnon and Stevens). In simpler terms, Stegers definition of globalization translates to globalization is a complex combination of social processes that intensify and expand worldwide economics, cultural, political, and technological exchanges and connection. Therefore when we talk of clinical trials going global, we refer to the process of expanding the horizons of studies on medical strategies by carrying them out worldwide or rather on global scale.
Why do we need to go global? A series of factors has led to the globalization of clinical trials. These factors can be viewed from a scientific and an economic aspect. From the scientific aspect, any medical research requires collection of data from a varied population. This is no exception for clinical trials. Geographical difference and ethnicity affects the safety of medical products since medical strategies such as drugs work differently on individuals of different ethnic background or geography. Therefore, when carrying out clinical trials during development of drugs or vaccines, it is essential that they be tested on a wide variety of individuals. Trials can also be of rare health events such as traumatic cerebral haemorrhage. In such cases, finding participants becomes a rather difficult and tiring process. This calls for conducting clinical trials across multiple countries so that a few participants can be recruited from each country. This is beneficial as it prevents prolonging trial period and time required to come up with lifesaving interventions. Carrying out clinical trials is also rather expensive and time consuming. Making matters worse, current clinical regulations have increased the cost and duration of clinical trials. The regulation serve an essential role in ensuring that clinical trials are carried out under high ethical standards, however it would be better if they were made less complicated. Due to the increased costs of the trials, most organisations opt to carry out clinical trials in regions where they would be relatively cheaper; this is because the cost of clinical trials differs with countries. For instance the cost of carrying out clinical trials in India is one tenth of the cost required to carry out similar clinical trials in the United States. The difference in cost is a result of different payment rates of employees in different countries as clinical trials is a labour intensive process. For instance, doctors from India would ask for less payment compared to doctors from the United States. Recruitment of participants is also easier in some countries than others. This necessitates clinical trials to be carried across multiple countries in order to save time used to conduct the trials. (Lang and Siribaddana)
Any company that is about to do clinical trials on a specific medical strategy needs to carry out a feasibility study before beginning the clinical trials. Feasibility study determines whether the trial is fit or not to carry out the clinical trials. During a feasibility study, it is essential to look at the current status of the disease incidence and its prevalence, competitive trials, information from past trials, country assessment, a review of the medical protocol, and a synopsis of the trials. The sites should also be identified and surveyed together with the enrolment targets. Through feasibility, the company gets thoughtful feedback on their planned studies and their knowledge of indication they are researching is increased. Furthermore, the company gets to see problems that may arise that may not have had thought of and to get appropriate solutions for these problems (Sunderland, p.2).
There are many benefits of clinical trials. Most of these benefits are patient-oriented; they benefit the patients that are recruited as participants of the clinical trials because most trials are on severe conditions that are difficult to treat such as cancer. Patients get access to treatment that is not yet available. The treatments may be more effective than standard or it may have a few side effects. Patients also get regular and careful attention from the best practitioners in the medical fields. Most research teams are made of top notch doctors from all over the world. Side effects of the treatments are observed and dealt with immediately hence they are not an issue. Even if the patient do not get the treatment being developed, they are better off in the hands of these doctors. The treatment that the participants get may also be free or low cost. Some of the trials may even cover travelling fees and other expenses of the patients during the entire study period. Patients also get a chance to contribute positively to the society; they get a chance to save many lives in future. The information gathered from the trials is eventually used to help others; therefore, participants of trials are vital to the process of health care improvement. (Breastcancer.org)
What are the advantages of clinical trials going global? Taking clinical trials on a global scale has also been advantageous in many ways. These advantages have contributed to more clinical trials being carried out internationally. First of it has enabled easier study of diseases whose prevalence vary geographically. The prevalence of a certain disease is affected by attributes such as genetic factors, cultural practices, environment and nutrition. These factors are mainly as result of geographical difference. A disease may be common in one country than the others, hence when choosing the site to conduct clinical trials it is best to choose a country where the disease is common. This has been enabled by clinical trials going global. An example is clinical trials carried out recently on the development of a vaccine for the Ebola virus that cause Ebola pandemic in Africa. The disease was most prevalent in parts of West Africa than other countries; hence the clinical trials were carried out in countries found in West Africa region. (Emanuel et al.)
Clinical trials have enabled enrolment of patients that have not yet participated in clinical results. Previously, before the globalisation of clinical trials, trials were carried out on the limited number of patients. Several clinical trials could be carried out but the population was still the same. The use of the same type of population over and over again in clinical trials results in redundant and inconclusive results of medical strategy studies. Globalisation of clinical trials has enabled clinical trials to be carried out on different populations hence developing a better understanding of what is being studied, for example, the long-term effects of a drug being developed. Moreover, patients from other countries may view clinical trials as an opportunity offering new treatment or otherwise unavailable treatment. Due to this, they may be more willing to participate in trials. (M.mddionline.com)
Since clinical trials are very costly to carry out in a certain countries, globalisation has enabled companies to get alternative sites where conducting trials is less costly. Most companies have recently developed a tendency of carrying out trials in China, India and Eastern Europe because it is less costly to carry out clinical research in these countries. In some cases, the cost per patient may be 30 to 60 percent less compared to conducting them in the US or Eastern Europe. For example the cost of developing a new drug in China is estimated to be about $120 million while in the US it is estimated to be about $1 billion. Apart from clinical trials being less costly, the population in these countries is drug-naive hence they are more willing to participate in the trial process. In a situation where the country cost is the same, globalisation of clinical trials is still beneficial in other aspects. For example, the start-up time is different due to the difference in time to get regulatory approval. (M.mmdionline.com)
Another advantage of the globalization of clinical trials is that it allows for the participation of countries that may later become potential markets for the tested product, device or medical strategy. For a drug to be approved for use in a certain country, the countrys regulation approval requires the participation of that particular patient population. Through participation of a countrys population, the countrys physicians get an early experience with products being tested in their patient. This lay a foundation for its regulatory approval in the country.
International sites for trials have also enabled clinical studies of seasonal diseases. Thus is because they allow spanning of climate zones and testing all throughout the year. The timeframe of getting the effective results is also shortened.
In short , the advantages of global clinical studies span from chances to work in areas where disease are most prevalent, chance of work with a drug naive population, ability to control the study start-up time, duration and cost, to opportunity to generate more sales of product by using countries that will later become markets of the product.
Despites the many benefits it has, international clinical studies have been faced with some drawbacks and potential risks. Some of the challenges that face international clinical trials include language barrier, differences in standard care, cultural and ethnic consideration and wrong interpretation of trial guidelines especially in developing countries (Lang and Siribaddana). There are also ethic issues that arise with protecting the rights of the participants of the trials so that they do not get exploited. Language barriers and over interpretation of guidelines are usually the major challenges faced.
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