How to Conduct High-Quality Population Studies Quickly and Cheaply Industry Shift in Emphasis
Effective clinical research is a combination of natural sciences and management. In discussions about clinical trials, the scientific aspect is the first to come up. And there’s no surprise there. After all, we are dealing with scientific research that must be conducted according to scientific methodology. However, today, that is no longer enough. In today’s world, it’s not just about inventing and testing a new drug. We expect, as patients, political or business decision-makers, and ultimately as a society, that drugs will not only be developed quickly but will also reach pharmacies just as swiftly.
The process of identifying effective molecules, designing, and testing new drugs is governed by scientific methodology and ethics. The substance must be safe and effective. It must cure, not harm. There are not many areas here that leave room for efficiency management. This is different from the area of planning, organizing, and administering the clinical trial process, especially in its clinical phase.
Organizations conducting clinical trials in the United States and Western Europe have undergone significant transformations over the past decades. The approach to clinical research has changed. The responsibility for the efficiency, speed, and quality of research has shifted to organizations known as Site Management Organizations (SMOs), which manage the processes of contracting and initiating research, patient recruitment, and studies in clinical research centers, as well as operational control and accounting.
The role of the researcher in the new way of thinking about clinical trials has not diminished. The researcher now has more time for the patient and medical procedures. Their mind is no longer preoccupied with paperwork and administrative matters, organization, materials and infrastructure, budget, and accounting. They no longer have to combine the roles of doctor and manager. Especially since combining these roles usually doesn’t work. And it happens to the detriment of patients and the quality of treatment. It also often leads to numerous ethically questionable situations.
New and Old Epidemiological Challenges
Particularly, the Polish clinical research industry remains organizationally behind the developed economies of the world, making it unable to fully exploit its enormous potential for many years.
Speed and scale of action have now gained even greater importance, especially in the area of testing population drugs, such as vaccines or drugs for common civilization diseases that threaten the lives and health of millions of patients. The ease of people’s movement, whether for business or tourism, significantly facilitates the spread of infectious diseases. Climate warming in previously cold zones opens doors for diseases typical of tropical zones. All these epidemiological dangers have one common denominator. They do not concern a dozen or even a few hundred people. They concern millions.
In such a situation, the clinical research industry, including the Polish one, must quickly develop its ability to rapidly conduct large-scale studies. This ability requires the combination of two factors: hospital infrastructure and professional organization of clinical research.
The sector that requires special attention is the SMO sector. It needs solutions that will significantly increase the scale and speed of action while ensuring patient safety, research quality, and ethics and transparency in responsibility and accountability.
Public Health Funds Require Better Supervision
No healthcare system has sufficient funds for healthcare. Besides seeking funding opportunities, the standard approach in such a situation is to increase the efficiency of spending the available funds.
Active public financing in clinical research of drugs considered socially priority is an important factor in the industry’s development in Poland. The creation of the Agency for Medical Research is the first but a milestone step in the right direction. Spending taxpayers’ money, however, involves much greater responsibility for its efficient use. Transparency in settlements, avoiding blurring the boundaries between obligations to the employer, patient, and the National Health Fund, and the research sponsor at all costs, is fundamental to effective and ethically and legally compliant research activities.
Tolerating ethically ambiguous situations by pharmaceutical companies and CROs, where a researcher representing a private research center, and at the same time an employee of a hospital, uses the infrastructure and patient databases of their employer without their consent or full awareness to conduct privately commissioned clinical research, is hard to accept.
Pharmaceutical companies perform their tasks by the line of least resistance, justifying their actions by the inability to change the established habits. Even if the hospital formally becomes part of the clinical trial agreement, it does not have appropriate services and competences to budget and settle medical procedures, use public staff and infrastructure involved in the study in the patients’ and its interest. This leads to the budget settlement of the study disconnected from the actual use of hospital resources. Then there are the dependencies and social ties, creating a recipe for an ethically questionable situation, sometimes against the law, and almost always financially inefficient for the hospital, thus depleting funds for other patient care.
Another important issue is the broader inclusion of young or inexperienced doctors in clinical research teams. The substantive supervision of an experienced principal investigator is entirely sufficient when the protocols of currently conducted studies precisely define the scope and standard of medical procedures, leaving the researcher little room for maneuver. A situation where even the most experienced and titled principal investigator limits the randomization of more patients due to lack of time (often combining the roles of head physician, doctor, academic teacher, scientist, managing their own business, chairman of numerous industry bodies and advisory bodies, and finally a parent) without making room for less experienced colleagues to conduct research is far from optimal.
Professionalization is the Separation of Treatment from Management
The professionalization of clinical research management involves separating medical functions from organizational and administrative activities. There is no reason why a doctor should also serve as a manager and operational controller. Not only because doctors often lack qualifications in this regard. Primarily because their valuable qualifications are needed in treating patients. Their involvement in non-medical and non-research activities makes them a bottleneck in the system.
A professional clinical research organization capable of handling large population vaccine studies requires specialized “civil” services that handle schedules, patient registration, CRF documentation, planning, and settling medical procedures. Also, the identification of potential study participants does not have to fully fall on the doctor, especially in the age of appropriate electronic patient record search tools and developed recruitment marketing. The doctor’s role in this regard is limited to the important function of pre-screening medical consultations and conducting the study protocol according to the inclusion criteria and screening and randomization scheme of patients.
The key to conducting high-quality population studies quickly and cheaply is managing them centrally by specialized hospital-based administrative and organizational units for the needs of research teams located in individual departments. These administrative units can be organized by the hospital itself, or, more likely in the initial phase, the organization and management of such a unit can be outsourced to a specialized and experienced SMO. Using appropriate budgeting algorithms will allow the financial “separation” of hospital resource use for the clinical trial. Each team member, including doctors, nurses, lab technicians, and pharmacists, can receive their remuneration for tasks performed as part of the study, and their working time on the study can be included in their hospital work schedule in a way that does not conflict with their daily work for non-participating patients.
There is Still Time for Change
Recent events related to the SARS-CoV-2 virus pandemic have shown how important the ability to conduct quick and large-scale clinical trials is. Perhaps the world and Poland are facing more epidemics that will require increased efforts from researchers and SMO organizations to deliver life- and health-saving drugs and vaccines. There is no better time than now to seriously consider structural changes in the way clinical trials are conducted in Polish hospitals.
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