Risks Involved In Enrolling In Clinical Research Studies

Introduction:Clinical research studies are run by pharmaceutical or biotechnology companies to test new drugs or to test additional uses (called "indications") for currently licensed drugs. Clinical research studies may also test devices such as heart monitors or diabetes test kits.

Before you volunteer to be patient in a clinical trial, you should be aware of some of the risks involved in enrolling in clinical research studies. The below risks are geared toward clinical research studies dealing with drugs, not devices.

  • 01

    Phase I Studies Test First In Man Applications

    Most Phase I clinical research studies are testing to see whether a drug developed in Research and Development (R&D) is harmful to humans. Animal studies have previously been done which, hopefully, show no serious adverse events (such as death) but, if you're enrolled in the first phase I clinical study for a medication, you might suffer adverse effects which are unpleasant. Typical adverse events include site of injection swelling or pain, fever, etc.

    You will be closely monitored by the study site and clinical trial management personnel through the trial and will be questioned about adverse events, but you should be aware of all risks before you sign up to be a subject in a trial.

  • 02

    The Study Drug May Not Work

    Some clinical research studies test drugs which are on a fast-track through the FDA as the disease they fight might not respond to other treatment or the other treatments available have horrible side effects. But, if you're involved in a fast-track drug (or even a traditional clinical study), part of the inclusion criteria might be that you must forgo traditional treatment (which might be proven to work) to test the new drug. Remember, there is not yet proof that the study drug works so you might be taking your chances if you have to give up your traditional treatment. Weigh your options carefully before shunning traditional treatment.

  • 03

    The Drug May Work But May Not Be As Effective As Traditional Treatment

    A Phase III clinical trial contains many more subjects than either Phase I or II studies and may check to see if the dose selected in Phase II studies is safe and efficacious (works the way it should). The phase III clinical trial might also test the study mediation against traditional treatment to see if the new drug works as well or better.

    During these trials, blood work will generally be drawn to see how long and how much of the study drug remains in your system at set periods of time. It's through these blood studies (pharmacokinetics) that the manufacturer of the drug can tell if the new study drug works as well as the drugs currently on the market.

    Some drugs are not approved by the FDA because, although they do no h arm, they show no benefit over drugs already on the market.

  • 04

    You Might Not Get Drug at All

    If the clinical trial you enroll in is double-blinded, neither the physician, the pharmacist dispensing the clinical study mediation or you will know who gets the actual study drug and who gets placebo so you might not be treated at all. Depending on your disease, this could be a very large risk to take as you might have to give up your traditional treatment and hope you're in the study arm that gets the test drug.

  • 05

    You Might Be Obligated to Appear For Annual Visits For Many Years

    Length of clinical trials vary greatly but, especially for cancer treatments, clinical studies may go on for years. You will be paid for your time, but it might become quite a hassle to make it in for your study visits. Make sure you understand your obligation - the FDA hates studies which has a large number of drop outs so the clinical study management personnel may be bugging you for quite some time to come in.

    Every clinical study has an Informed Consent document which lays out all of the benefits and possible negatives of the study. It also documents the exact number of blood draws, study visits, and the duration of the trial. Make sure to read and thoroughly understand the Informed Consent before signing up for a clinical study.




Final Thoughts

As a Data Manager with 20 years experience, I think that anyone considering enrolling in a clinical trial should be extremely aware of the risks involved. Although it might be very tempting to jump on board a paid clinical trial, it might not be your smartest move.

Do NOT hesitate to talk to study personnel at the study site to answer any and all questions you have before you sign up for a clinical research study.


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Comments

  • goodselfme 8/6/2013 Flag This Comment

    Well done list! Thank you and congratulations on the front page spot.

  • Wasatch 8/5/2013 Flag This Comment

    Good list! And glad to see a front page change this quarter.

  • litetender 4/25/2011 Flag This Comment

    It is good to consider these things!

  • ListMaker 1/25/2011 Flag This Comment

    Joan: it's always a good idea to throughly investigate and understand the clinical study before volunteering.

  • MiddleSister 1/21/2011 Flag This Comment

    I hear solicitations for people to participate via radio ad. I've always wondered about it. It's good to know the right questions to ask. Thanks.

  • ListMaker 1/21/2011 Flag This Comment

    Clarific: privacy is not a real concern in an FDA trial as the only identifying marks on the case report forms (the forms the study sites fill out) is a number each subject is assigned and possibly initials but some study sites won't even allow initials. You're right to be worried anyway.

  • ListingToTheLeft 1/21/2011 Flag This Comment

    This information can be so helpful to people considering doing this. Good concerns to think about.

  • clewand550 1/21/2011 Flag This Comment

    Very good reasons to think about if this is really something you want to do. Great list of 5. This can be pretty scary if something does go wrong. H5.

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