Tag Archives: protocols for clinical trials

Parsing the protocol

I’m as a big a fan as anyone when it comes to medical research. Without the opportunity to participate in clinical trials, I would have been dead years ago.

However, I think it is a misperception to imply that accrual to trials is simply a problem of access.

Access may well be problem number one. If you don’t know, you can’t act. But it is hardly as simple as that.

First, you have to qualify. This includes a comprehensive screening process that evaluates demographics, medical history, blood and tissue tests (in the case of tissue, either archived or fresh biopsy), physical examination, performance status, vital signs, eye exams, ECG, ECHO, assessment of tumor through X-ray, CT scan or MRI.

If you jump successfully through all these hoops then you potentially are eligible.

Next, you are presented with a document referred to as an informed consent. Exactly one paragraph is devoted to the rationale as to why this therapeutic may effectively inhibit cancerous growth:

DS-1062a targets a protein called trophoblast cell-surface antigen2 (TROP2) which is found on the surface of cancer cells in large amounts. DS-1016a is made up of an antibody that binds to TROP2, and a drug of topoisomerase I inhibitor, which is called ‘MAAA-1181a’ It is thought that DS-1062a may slow tumor growth by attaching to TROP2 and releasing the drug inside the cells.

Now that you’ve had a chance to kick the tires, the rest of the 23 pages is primarily devoted to nuts and bolts of both what your commitment shall be, what theirs shall not be, as well as a comprehensive list of potential side effects.

It is stated on page one that for the purposes of this study, you will be referred to as a ‘participant’. That is an important distinction. Not patient, not person, but rather, participant.

As a ‘volunteer’, you may decide to discontinue the study at any time. However, you may also be removed. The primary reason for removal is stated as such You will be in this research study for as long as your tumor does not get larger or no new tumor is found.

But there is more:

You may be taken off the research study drug for many reasons including if:

It is considered to be in your best interest

The study treatment or procedure are found to be unsafe or ineffective

There is any problem with following study treatments and procedures

You are a female and become pregnant or plan to become pregnant

Your condition worsens

A decision is made to close the study

Or for other unforeseen reasons that make it necessary to stop you participation in the research study

After this, the risks are addressed, but not before this statement is made: If you experience side effects, they may go away after you stop taking the study drug. Some side effects can be mild; but others can be long lasting and may never go away. Some may be life-threatening or fatal.

Still interested? After reading the long list of potential side effects (which I shared in yesterday’s post), put on your altruism hat. Under ‘What are the benefits of the research study?’ is this very candid assessment: We do not know if taking part in this study will help you. This study may help researchers learn information that could help people in the future.

And then the real nitty gritty. ‘Will I be paid to take part in this research study?’ You will not be paid for participating in this study. We may use your sample and information to develop a new product or medical test to be sold. The sponsor and hospital may benefit if this happens. There are no plans to pay you if your samples are used for this purpose.

Ok then. But what about costs? Taking part in this research study might lead to added costs to you or your insurance company. You will not be charged for DS-1062a. It is possible that DS-1062a may not be continued to be supplied free for some reason, It this would occur, your research doctor will talk with you about your options. You or your insurance company will be charged for portions of your care during this research study that are considered standard care. You may be responsible for copayments and deductibles that are typical for your insurance coverage.

What if you are injured or become ill due to participation? The treating hospital will offer you the care needed to treat injuries directly resulting from taking part in this research. These treatment will be billed to your insurance company. You will be responsible for deductibles and co-payments. There are no plans to pay you or give you other compensation for the injury. You do not give up your legal rights by signing this form.

And data. That damned data. While all reasonable efforts will be made to protect the confidentiality of your protected health information, it may also be shared with the following agencies: (yada, yada, yada). And then this nugget: Some who may receive your protected health information may not have to satisfy the privacy rules and requirements. They, in fact, may share your information without your permission.

As far as accessing your own data, you have the right to it request it but ‘only after the study is completed.

There are four optional studies addended, two of which I said no to (use of archival tissue and a third thoracic biopsy). Two others I assented for, as they merely required additional blood draws and storage and potential use of remaining biological sample including tissue. Interesting to note was this bit of information though: The results obtained from samples will not be provided to you or your study doctor. The results may be published in academic journals or discussed in conference. Even in that case, your personal information will not be disclosed at all, so your privacy is strictly protected. Your sample test results may result in findings that have value. The Sponsor may gain financial benefit from these findings. You will not have any right to any of these findings or financial gain.

I like to quote Richard Pazdur of the FDA, whom I once heard say ‘People are not for clinical trials. Clinical trials are for people.’ Maybe so. And perhaps that is why it is necessary to call us participants, scrub our humanity from us.

So yes, I am grateful to medical research. But I am also highly critical. Any attempt to call this a partnership is disingenuous. A relationship, yes. But not one of equals.

Read that fine print.