Medical Model

Drug Trials: Do a Legal Double-Check Before Signing Up

By Pamela Miller, OD, FAAO, JD

Participating in drug trials offers patients access to treatments that can transform their lives. This also offers doctors a chance to enhance their professional profile. Before signing your practice and patients up, check the legal fine print.

Drug and product trials in which a medication or new product is put to the test in a practicing optometrist’s office with real patients is an opportunity to bring patients the cutting-edge in treatments. Participating in these trials may mean finding a treatment or a product that can help a patient who has been struggling for a long time. At the same time, drug and product trials pose potential risks to patients and the doctor.

Doctors are sometimes compensated for participating in drug trials, but the greater opportunity is that bringing vision and eye health solutions to patients who have tried all other possible solutions, is a practice builder that enhances your practice’s prestige. More importantly, if the trial drug or product is a success, you are able to vastly improve the life of a patient. That is satisfaction in itself, but that patient also will become a great booster for your practice, often referring friends and family.

As with all legal matters, it is best to check with your attorney and state optometric board before participating in any drug or product trial.

Approached Usually By Third Party

Typically, doctors asked to participate in a drug trial are approached by a representative for the manufacturer that produces the drug or product in question. Sometimes the representative reveals the name of the manufacturer, and other times just the product or drug, its benefits and risks, are explained to the doctor with the doctor given an information packet to study. Sometimes the doctor is asked to give some of the patients an active drug and the other patients a placebo without even the doctor knowing which patients have received the real drug and which the placebo. The information packet and instructions the doctor is left with should always include information about the mandate for informed consent, meaning a form patients must sign detailing their understanding that they are taking part in a drug or product trial that may pose certain dangers.

Manufacturers conducting drug or product trials are looking for a significant sample size, so they usually will only approach doctors who are known to have numerous patients who might be able to benefit from the drug or product in the trial. For example, if a new contact lens for presbyopes is in the trial stages, the vendor might look to an OD practicing in an area with many older patients and a strong contact lens niche. If the drug is intended to treat glaucoma, the vendor will look at ODs who have not just one or two or three of these patients, but ideally, dozens.

Be Honest With Patients of Potential Benefits and Risks

The best approach is to be completely honest with patients. As a doctor administering the trial, you are required to get signed informed consent from the patient, but beyond that, have an open conversation in which you detail the possible benefits and any hazards. For example, I have been asked to participate in drug trials for dry eye medication. I might say: “Betty, I have been asked to participate in a drug trial for a new dry eye treatment that I think may help you. The risks the manufacturer informed me of are minor, such as temporary burning and stinging in your eyes, and the benefits could be great. We’ve tried all the standard treatments available for dry eye, so I think you would be a good candidate to give this new drug a try.”

Patients who experience adverse reactions while taking the drug or using the product can sue the doctor (because anyone is free to bring a lawsuit about anything), but with documented, signed informed consent, the doctor’s defense is simply that the patient signed that he fully understood the potential risks and was still willing to try the product. A patient with an adverse reaction also may be found to have not followed directions in dosage or may have used another drug at home that interacted badly with the drug the doctor gave him for the trial.

Doctors have a greater chance of being found liable in cases of adverse patient reactions when the doctor did not follow the protocol they agreed to when signing on to administer the trial. For instance, the doctor may have given the drug to a patient who was not a participant in the trial or maybe they forgot to make sure the trial participants returned for follow-up exams.

Detail Patient’s Responsibilities During Trial

Once the patient agrees, you must explain what is expected of them as a participant in the trial. For instance, explain what the patient has to do (i.e. administer eye drops three times a day), how often they have to return to your office and the need for them to document all problems they have while taking the drug regardless of how insignificant the problem may seem. Patients also should be given a heads-up of how long the trial will last. Usually, trials last at least one to two years so the manufacturer is able to get a good sense of any possible side effects. It sometimes takes many months of use of a drug or product before problems arise, so manufacturers are usually careful to devote enough time to each trial. The drug or product in the trial are provided free-of-charge to the patient, so the patient is only charged for the doctor’s time.

Doctor Typically Signs Non-Disclosure Agreement

If a manufacturer has a break-through medication or product, the last thing they want is for a doctor administering a trial to talk about the drug or product before the manufacturer is ready to bring it to market or prior to it being approved. Obviously, they don’t want to give their competitors advance notice of the potential blockbuster drug or product they will be introducing. For that reason, the doctor is usually asked to sign a non-disclosure agreement in which the very existence of the product or drug and the trial is not discussed with anyone outside participating patients, the manufacturer and (if separate from the manufacturer) whoever is conducting or organizing the trial (manufacturers will sometimes hire third parties to find doctors and organize and implement the process).

Participating doctors are given a packet of information detailing their responsibilities including the specific drug or product they will be administering, how it will be given to patients (self-administered or at the doctor’s office, etc.), how the trial will be explained to patients, the doctor’s obligation to report back findings to the manufacturer (how often–weekly, monthly, etc.) and the doctor’s need to follow-up with participating patients to ensure no preventable adverse reactions occur and all benefits or problems are discovered and reported.

Keep Records of Patients Participating in Drug or Product Trials Separate

Just as the patient must document any issues that arise while taking the drug, the doctor administering the medication or prescribing the product must keep detailed accurate and copious records that are kept separate from the records of their other patients. While the patient’s participation becomes part of her health record, you also need to keep a separate study file for research that does not name patients to share with the drug or product manufacturer. To avoid using patient names in the study file that will be shared with the manufacturer, use patient initials or numbers instead.

Right to Pull Out of Study

If a doctor notices a serious adverse reaction in many patients, it would not be responsible of her to keep her patients on the drug. For that reason, most studies have clauses that allow the doctor, under extreme circumstances like vision- or life-threatening patient side effects, to pull out of the study. However, if the side effects are not vision- or life-threatening, ODs typically will be expected to finish the trial.

Do Not Administer Trial Drugs or Products to Minors

Minors or legally incompetent adults (such as those with mental retardation or other cognitive disabilities) are not permitted to be study subjects. In the rare instance that a trial product or drug has the potential to benefit a minor or legally incompetent adult, the doctor would recommend the patient for the study, but the patient may then be sent to a special research facility.

The bottom line is that when you are participating in any drug trial, you have an increased responsibility that extends to your patient, as well as the manufacturer, to be both prudent and meticulous in your care and documentation.

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Pamela Miller, OD, FAAO, JD, DPNAP,has a solo optometric practice in Highland, Calif. She is an attorney at law, holds a therapeutic license, is California State Board-certified and glaucoma-certified to prescribe eye medications, and offers comprehensive vision care, contact lenses, visual therapy and low vision services. To contact her: drpam@omnivision.com.

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