Clinical trials of medical products and medical devices: what you need to know

Clinical trials for medical products

There is constant innovation throughout the medical field and every year hundreds of new medications, devices and surgical techniques are developed and tested. The vehicle for testing drugs and devices (such as artificial discs or spinal fusion implants) prior to allowing them for use by the general public is usually a clinical trial—a controlled test where the new product is provided to participants who have given their consent, and the results are tabulated and documented to determine if the product is safe and effective for a specified condition or disease. Clinical trials are conducted at research institutes, teaching hospitals or clinics by appropriately trained clinicians and doctors who may or may not receive a stipend or consulting fee for their assistance.

To learn more about clinical trials that are proposed and/or enrolling participants for new spine devices and treatments, see Spine-health.com’s Clinical Trials page. (Please note that the trials listed are paid listings by the study sponsors.) The National Institutes of Health has general oversight and enforcement powers regarding the conduct of all clinical trials that involve humans.

Who is involved in conducting a clinical trial?

The design and execution of the clinical trial is actually a collaborative effort among several entities or individuals. The primary roles in clinical trials are:

• Clinical trial sponsor: generally, the sponsor is the manufacturer of the product being tested, e.g., a company that designs and builds a device like an artificial hip or develops a new drug. The sponsor does not actually conduct the clinical trial for its product. The federal government also sponsors trials.

• Investigator: the person responsible for executing the clinical trial design and reporting results. Lead investigators in clinical trials have oversight for all or multiple sites where the trial is being conducted as well as for reporting results.

• Subjects: the patients who have given their consent to participate in the clinical trial.

• Institutional Review Board (IRB): An IRB is empanelled to oversee every clinical trial in the U.S. The IRB is an independent committee made up of doctors, analysts, community advocates, and others in order to ensure that the clinical trial protocol is ethical and the rights of clinical trial participants are protected.

Can anyone enroll in a clinical trial of a new medical product?

No, the criteria for selecting clinical trial participants are usually fairly rigid because trials (and products) are designed to address a specific health problem or condition. Participants must be screened carefully to determine if their health profile conforms to the targeted audience for the product. Some commonly used terms are:

• Inclusion criteria: the characteristics that clinical trial participants must have in order to participate. For example, if a new spinal disc is tested, participants might have to have a certain level of disc degeneration to be selected. Another word used for this is “indications”.

• Exclusion criteria: these are characteristics that would preclude people from participating in the clinical trial. By way of example, people who have had fusion surgery, or suffered from advanced spinal arthritis, might be excluded from a clinical trial because their spines already show significant differences from those of people for whom the product was developed. Their participation might skew the results of the trial, and/or a particular product might not be safe for those people. Another word used for this is “contraindications”.

Participants who meet the inclusion criteria and are selected to participate are often required, as a condition of participation, to inform the trial investigator of any changes in their health status (for example, if they are diagnosed with another condition, or if they begin taking a different drug) so the clinical trial sponsor can determine if they still meet the inclusion criteria.

Are there different types of clinical trials?

Yes, and each has different objectives. Treatment clinical trials that test experimental drugs, devices or therapies are the most well-known, but there are other types of clinical trials too, including:

• Prevention clinical trials to identify ways to prevent disease (e.g., diabetes) in people. Strategies tested may include lifestyle changes, as well as medicines and vaccines, vitamins and minerals.

• Diagnostic clinical trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

• Screening clinical trials test the best way to detect certain diseases or health conditions.

• Quality of life clinical trials usually involve participants who have a chronic illness and aim to provide comfort and reduce discomfort, rather than find a cure for that illness.

Will I get paid to participate in a clinical trial?

It depends. Sometimes participants will get some form of compensation from the clinical trial sponsor, though it may just be a small stipend. Often, the sponsor of a medical device clinical trial will pay for the cost of the device itself (e.g., the cost of the artificial disc), but will not pay for the actual surgery to implant it (e.g. the hospital costs, the surgeon’s fees, or for post-operative care). In addition, it is not typical for insurance companies to pay for a procedure in a clinical trial, as most insurers will not pay for procedures that are deemed experimental or investigational. It is not unusual for participants in clinical trials to be out-of-pocket some money, sometimes a significant amount of money, if invasive surgery is involved. However, in some cases the trial sponsor will cover doctor, hospital, device and surgery-related costs that are not covered by insurance. With this degree of variability, potential participants are advised to make sure they understand the financial arrangements for the particular study they are considering.

Is it safe to use the new medical products being tested?

Generally speaking, it is safe although some trials are stopped or redesigned if unacceptable side effects occur. The objectives of most clinical trials are to prove the efficacy and demonstrate the safety of the medical product or medical device before it is sold commercially. By definition, then, some products that are perceived to be safe turn out to have significant risks and side effects and consequently are never produced for commercial sale or are later taken off the market, modified or the indications for use restricted. Nonetheless, if you are selected, manufacturers will want to ensure that your participation is a positive experience and managed under safe conditions, although they cannot (and should not) guarantee specific outcomes. Sponsors have little financial incentive to develop devices and have them implanted under unsafe conditions, which could seriously harm their reputations and financial position. Rather, manufacturers want to partner with research institutes and clinicians that they can trust to conduct the procedures and use the device the way it is intended. Despite these incentives, there are risks to the patients. A few of these risks include:

• There is often a steep learning curve involved in implanting new devices/doing new surgical procedures, so a surgeon is usually still learning about the procedure during a clinical trial.

• As with any new procedure or medical product, there are unknown short term and longer term risks involved in using investigational devices.

• The new procedure may not be effective for the participant. In the case of a surgery, that means the patient will have undergone an invasive procedure for no benefit.

Please note that the contents of this article synthesize publicly available data and have not been peer-reviewed by Spine-health.com's Medical Advisory Board.