Clinical research plays a vital role in the advancement of medical knowledge and the development of new treatment regimens to combat diseases and advance patient care. Without clinical research, it would be almost impossible for pharma companies, physicians, and healthcare providers to determine whether new treatments work properly in a clinical setting.
Clinical trials ? a type of clinical research ? study and evaluate the effects of new medical devices, new tests, new procedures, and new medications on human health outcomes. Often, clinical trials are used to determine if a medical intervention intended for the general population is safe and effective.
They are also important for testing whether a treatment regimen is acceptable to a larger proportion of people than the existing treatment. Overall, they’re a key research tool that advances medical knowledge related to the analysis, prevention, diagnosis, and treatment of chronic health problems and degenerative diseases.
As with any industry, there are numerous challenges that clinical trials stakeholders face before starting and when conducting these complex, lengthy, and expensive trials. However, there are still a variety of issues and challenges that occur during trials.
Complex Regulatory Requirements
Research related to chronic health problems, infectious diseases, and public health has evolved into a global enterprise transcending regional and national borders. Many countries across the world have formed organized networks that allow them to conduct multi-country clinical trials to combat diseases.
While this is essential in advancing prevention, treatments, and cures for various chronic and degenerative diseases?and improving the health of people around the world?it raises regulatory related challenges.
Clinical trial sponsors and investigators have to ensure that they comply with all the regulatory requirements in each collaborating country. The significant differences in the regulatory environment and the laws in each of the countries involved create a very long, complex regulatory process that may delay clinical research, affect the implementation of clinical trials, and cost millions of dollars every year.
Complexity of Trials
A new study by the Tufts Center for the Study of Drug Development (CSDD) has found that trials are increasingly becoming complex. According to CSDD, clinical trial durations have become longer due to more complex designs, more protocol deviations, and difficulty recruiting and retaining study volunteers. Some trials generate more substantial protocol amendments while others require more investigative sites, which creates more complexities.
Additionally, investigators and Clinical Research Organizations (CROs) feel like they must design trials that deliver the best results that are acceptable to sponsors and regulatory bodies. They also feel the pressure to create the best trials to give accurate answers for patients in the simplest and most unobtrusive way possible.
Antiquated Mapi Translation Services
When trials are underway, the trial management needs to make sure that the data being collected is accurately captured and the sites are well-monitored. As mentioned, clinical research has evolved into a global enterprise transcending regional and national borders.
Investigators and Clinical Research Organizations (CROs) are now conducting multi-country and multi-regional trials, which raises the need for translation services to address language barriers; something that is typically aided with proper Mapi translation.
The continued use of outdated Mapi translation services by investigators remains a major challenge today. Using Mapi translation may still work when it comes to translating surveys and questionnaires for trials but there’s need to adopt a responsive translation approach that uses ISO-certified processes and the latest international standards.
Spiraling Clinical Trial Costs
According to a 2016 study, it costs an average of $1.4 million to $6.6 million for pharmaceutical companies and organizations to conduct Phase 1 clinical trials at a site in the United States. The study further revealed that Phase 2 and Phase 3 studies cost from $7.0 million to $19.6 million, and $11.5 million to $52.9 million on average, respectively.
These figures are even much higher today as they’ve been increasing over the past few years. This is primarily because of the complexity of regulatory requirements and more intensive reporting and monitoring guidelines being used today as a result of multi-country and multi-regional clinical trials.
It’s also worth mentioning that a larger segment of the general population across the world is aging, and this has shifted the focus to chronic disease research, which has significantly increased drug development expenses.
Patient Recruitment and Access
One of the challenges that clinical trial investigators and sponsors face just before starting trials is difficulty in enrolling patients. Recent statistics show that about 80 percent of clinical trials are either delayed or terminated due to low patient recruitment. The Tufts Center for the Study of Drug Development also notes that nearly 4 in every 10 sites in a given trial fail to enroll enough patients, and 1 in every 10 sites don’t find a single patient to enroll.
The low patient recruitment challenge is often a result of increased competition for the limited pool of patients for specific conditions. Incentives and knowledge of potential participants and their respective healthcare providers and/or physicians have also been shown to hinder participation.
