It is at best uncertain whether you or anyone else currently in your condition will benefit from your participation in a clinical trial. If the trial is successful — and as we have mentioned earlier not all of them are — and the drug or appliance is cleared for marketing, some of those who get a similar condition in the future may benefit from it. Your participation is your legacy to them. But the important question is, “Who benefits now?” That is particularly relevant since large amounts of time, effort and money go into clinical trials. Someone must believe the investment is worthwhile. Let’s take a look at each of the stakeholders.
Those conducting trials are stakeholders in it. They benefit from it. They include:
- The doctors and other practitioners involved.
- The organizations and institutions they are a part of and represent– the Medical Centers, Hospitals, Universities and PhysicianFirms.
- The pharmaceutical and medical equipment companies whose products are being tested and who sponsor the trial whose self-interest is definitely connected to the success of the project.
The principal investigators — a.k.a., the lead doctors — have their reputation on the line. The study is based on their hypothesis. If the clinical trial turns out favorably, they can say, “See I was right!“ Not only is that a boost to their ego, it enhances their reputation and all that goes along with it. If successful, they get to publish the results and present the findings at national meetings. Moreover, it enables them to test out their ideas, to get funds for their projects and it increases their income as well. Those personal benefits contribute to their wanting you to participate and, perhaps, inadvertently encourage you to do so. That is particularly true when the number of possible candidates for the clinical trial is limited, and the lack of participants threatens the validity of the results or even makes it impossible to conduct the trial. In fact, the possibility of being pressured to enroll has led to the requirement that in order to participate in a clinical trial you must sign a form indicating that you are giving your informed consent. Continue reading “Should I Enter a Clinical Trial–Part Two–The Beneficiaries”
I — The Issues
With few exceptions, every prescription and over-the-counter (OTC) drug and medical device marketed in the U.S. has to be approved by the Food and Drug Administration (FDA) for efficacy and safety. That is where clinical trials come into play. They provide the information required for clearance. It is critically important to realize that for any drug or device in a clinical trial it is impossible to know beforehand what the outcomes of the intervention — both favorable and unfavorable — will be. No one — not even the best informed minds — know that. That is the reason for having a clinical trial. The trial is based on an hypothesis — a.k.a,, a guess. Sometimes it is correct, sometimes not. If the outcomes, or the range within which they fall were understood, there would be no reason for the trial.
Not all clinical trials are successful. Some drugs do not even make it through Phase I (which determines if the drug is safe and the dosage levels). Others are withdrawn before they complete Phase II (which tests for efficacy and safety). They can be withdrawn because they are ineffective, unsafe or have damaging side effects or considered to be non-profitable. Still others may not offer a significant improvement over current therapy represented by the control group. Only some of the ones that get through those hurdles are ultimately cleared for marketing by the FDA.
Continue reading “Should I Enter a Clinical Trial–Part One”
Time is a limited resource. There are just 24 hours in a day. No more, no less. All mammals must consume the basic survival inputs — clean air, fresh water and food, resting and using clothing and shelter. Time must be spent gathering, preparing or producing the food and other inputs, in making them ready for consumption, and in cleaning up afterward. Whatever time is not spent on those activities is available for other things.
If you are not directly involved in making any of those inputs, someone else must do that. In order to compensate them for the time, effort and other resources they spent in the production of inputs and making them ready for your consumption, you must use some of your left over time to create an income — either as physical outputs or their monetary equivalent — to pay for the goods and services they provide. That enables you to compensate them. Otherwise, you are expecting or getting a gift from them.
You’ve heard of discretionary spending. It is buying things after you have taken care of the necessities. The same thing goes for time. Once you’ve utilized your time to take care of providing the basic inputs, you have the opportunity to allocate the balance of it to those other things you want to do most. But the available time is limited. Every hour you spend on anything, you are giving up the possibility of using it for something else. Typically you have a number of alternative ways to spend the next hour. Some are more important than others. Clearly, spending time on the basic necessities comes first. After that, then what? Continue reading “Thinking About How You Spend Your Time”