Clinical trials in the 21st century are conducted with the involvement of multiple stakeholders like clinical investigators, patients, hospital staff, physicians, regulators, and research sponsors that include government, academia, industry, non-profit organization among others. Each of these stakeholders bring different resources into the trial and varies from monetary resources to research knowledge.
One of the major challenges facing clinical trials is the cooperation of all stakeholders and their resources in a coordinated manner. If one clinical trial is conducted by setting up a nodal center and the resources marshaled, the next trial starts again from scratch instead of drawing ideas and resources from the previous trial.
There exist systemic challenges to the clinical trial process and infrastructure. They are as follows:
- Clinical research questions need to be prioritized
- Bridging the divide between clinical research and clinical practice
- Globalization or outsourcing of clinical trials of developed countries to developing countries due to cost benefits
Currently, each stakeholder sets up clinical trials to investigate based on their wish and motive. For example a pharmaceutical company may want to test a drug in order to be able to sell it in the market and gain profit which is not what a clinical investigator might want. This needs to be streamlined so that trials can focus on actual requirements of the day that benefit the large majority of people.
Clinical trial research is facing the problem of few community physicians engaging directly in the clinical trials by referring patients and starting a clinical trial based on a research hypothesis. It was found that practicing physicians rarely venture into clinical investigation due to the lack of abundant funding options and the regulatory quagmires that an individual would have to go through, not to mention the time taken in completing one full trial cycle.
Globalization of clinical trials is also a major concern. When a clinical trial for a drug is conducted outside the USA, the results of the trial cannot be simply applied for US population because people are inherently different and react differently to different drugs. The Food and Drug Administration (FDA) will question the efficacy of the drug on a same population sample in the American population. Also the standards of clinical practice in other countries may vary along with the manufacture of the drug.
Apart from these challenges, there exists the problem of recruiting volunteers and patients for participation in the clinical trials. Each trial requires healthy volunteers or patients in hospitals who are referred by their physicians. The number of volunteers registering to participate in clinical trials in the USA has been declining due factors like :
- lack of awareness of clinical trials
- preconceived notions about clinical trials
- lack of informed consent practice by the research sponsor
- fear, distrust, or suspicions of research
- practical or personal obstacles
- unwillingness to go against personal physician's opinion
Also community physicians themselves rarely engage with clinical trials due to various factors. They are :
- belief that standard therapy is best
- lack of awareness of clinical trials being conducted
- unwillingness to lose control over personal care of their patient
- belief that participating in clinical trials leads to added administrative burdens
These challenges are some of the major obstacles in enabling clinical trials from becoming a well-oiled process that can enable humans in discovering really helpful drugs.
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