Is Clinical Trial A Product Or A Service? in a recent ACT ‘What do you think?’ survey, readers were asked if a clinical trial is a service or a product. Only 53% of people identified a clinical trial as a service. Other responses included product (7%), neither (20%), or other (20%) with the most common response in the other category being ‘research.’
These responses are quite typical. There is a lot of confusion within the industry about what the value developed by clinical trials – even till the point of knowing whether a clinical trial is a product or service. This confusion degrades value creation, productivity.
Clinical trials are done to collect data regarding the safety and efficacy of new drug and device designinh. There are many steps and stages of approval in the clinical trials process before a drug or device is out in the consumer market.
Drug and device testing starts with laboratory research which can involve years of experiments in animals and human cells. If the initial lab research is successful, researches send data to the FDA for approval to continue research and testing in humans.
Once getting the approveal, human testing of novel drugs and devices can start and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of the phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.
Basically clinical studies are designed to add to medical knowledge related to the diagnosis, treatment and prevention of diseases or conditions. Some common reasons for conducting clinical studies are:
- Assessing one or more interventions for treating a disease, syndrome, or condition
- Finding ways to avoid the initial development or repearation of a disease or condition. These can include medicines, vaccines, or changed in lifestyle , among other approaches.
- Assessing one or more interventions aimed at identifying or diagnosing a particular disease or condition
- Examine methods for identifying a condition or the risk factors for that condition
- Finding and measuring ways to enhance the comfort and quality of life through supportive care for people with a chronic illness
A clinical trial is a service, as the application of knowledge and skills to benefit another entity. The keyfeatures of services are that they involve delivery processes. Products are goods manufactured basically in a yield setting. It is much easier to measure and organise the yield process of products. Service processes are much more difficult to measure and manage.
This doubt about whether a clinical trial is a service or product also results to lower-quality clinical trials and billions of dollars wasted on ineffectual quality improvement investments. Yet, the industry measures trial quality as if it is a product – leading to mismanagement and low-quality trials. The industry has spent billions of dollars trying to improve the quality of trials in the past years without any improvement in reality. The basic reason is that the industry still hasn’t figured out if a clinical trial is a peoduct or a service .
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