Clinical trials devices

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Clinical trials devices

Our objective was to describe the costs of industry-sponsored clinical trials for medical devices in Northern Alberta, Canada. We used centralized data to identify all industry-sponsored medical device clinical trials initiated in Northern Alberta from to For each arm of each trial, we calculated the price of devices provided by the sponsor and the cost of clinical and administrative services that were incurred to clinically operationalize the treatment.

Our sample consisted of 18 device trials initiated between January and January Data from industry-sponsored clinical trials can provide important information on the full costs of device-related interventions.

As device costs rise, and as policy makers require more evidence on device-related treatments, the cost of medical device-driven interventions should be documented along with their effectiveness. Clinical trials CTs are important components in the licensing of medical devices [ 12 ].

Health Canada is responsible for issuing approvals to allow trials with a medical device to be conducted in Canada [ 2 ]. The design of a medical device CT differs from that of a drug CT: randomization is not common for medical device CTs and it is difficult to ensure blinding for individuals or investigators in a device trial. Medical device CTs are usually conducted with smaller patient populations [ 3 ] and have mostly been designed to generate endpoints to meet the approval requirements of the regulatory agencies [ 4 ].

Although studies exist that document the economics of clinical research, these are for pharmaceuticals or medical and surgical procedures [ 5678 ]. The research, development, and approval process is much more developed for drugs than for medical devices, although recent news reports by an international coalition of investigative journalists called for increased clinical research on specific devices [ 9 ].

Prior to this call for evidence, the importance of clinical research on devices had already been growing. Although the US FDA and Health Canada do not require economic data in their approval submissions, the rapid growth of expenditure on a variety of medical devices [ 11 ], and the growing requirements for industry-provided evidence, calls for a greater degree of economic considerations in CTs.

Even though we know the amount that the industry spends on total research and development, almost no information is available on expenditure and costs of clinical as opposed to basic research for medical devices.

Clinical research is the medium through which devices are formally tested and compared with alternative treatments. Economic aspects of clinical research provide important information to policy makers on the full cost of alternative interventions, not just on the device costs themselves. As CTs also impose a burden on developers, it is important to have an estimate of the magnitude of this.

Phases of Clinical Trial

There is growing interest among policy makers to increase the scrutiny of the performance of new technologies, including medical devices.

CTs will play a major role in this movement. The purpose of this study is to describe the costs of industry-sponsored CTs for medical devices in Northern Alberta, including the types of trials and their costs of devices and associated clinical services. The healthcare system in Alberta is a single, province-wide, fully integrated institutional service provided by Alberta Health Services AHS [ 14 ].

Some devices are purchased or funded through a specialty program led by the provincial health ministry. The Alberta Aids to Daily Living Program also provides financial assistance for the purchase of medical equipment for people on low incomes with long-term physical disabilities or chronic or terminal illnesses [ 1 ]. Data describing the CT, including clinical protocols and budgets, are maintained in a central database.

Clinical services budgets and overheads that go into the contracts are set by AHS-Finance and reflect actual costs.Clinical studies on human subjects that is conducted within the United States and U. Guidance on these requirements can be found on the CDRH website.

FDA will accept clinical data from these investigations if the following information is provided for each investigation, as applicable.

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A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval described above may be approved if:.

Applicants who seek approval based solely on foreign data are encouraged to meet with FDA officials in a presubmission meeting. In determining the safety and effectiveness of a device for Premarket Approval of class III devices, FDA will consider the following, among other relevant factors:.

Managing Adverse Events and Effects during Clinical Trials

Although the manufacturer may submit any form of evidence to the FDA in an attempt to substantiate the safety and effectiveness of a device, the FDA relies upon only valid scientific evidence to determine whether there is reasonable assurance that the device is safe and effective.

Valid scientific evidence is evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use.

The evidence required may vary according to the characteristics of the device, its conditions of use, the existence and adequacy of warnings and other restrictions, and the extent of experience with its use.

Isolated case reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated opinions are not regarded as valid scientific evidence to show safety or effectiveness.

U.S. Food and Drug Administration

There is reasonable assurance that a device is safe when it can be determined, based upon valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks.

The valid scientific evidence used to determine the safety of a device must adequately demonstrate the absence of unreasonable risk of illness or injury associated with the use of the device for its intended uses and conditions of use. Among the types of evidence that may be required, when appropriate, to determine that there is reasonable assurance that a device is safe are investigations using laboratory animals, investigations involving human subjects, and nonclinical investigations including in vitro studies.

There is reasonable assurance that a device is effective when it can be determined, based upon valid scientific evidence, that in a significant portion of the target population, the use of the device for its intended uses and conditions of use, when accompanied by adequate directions for use and warnings against unsafe use, will provide clinically significant results.

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The valid scientific evidence used to determine the effectiveness of a device shall consist principally of well-controlled investigations. The following principles are recognized by the scientific community as the essentials of a well-controlled clinical investigation.

They provide the basis for FDAs determination whether there is reasonable assurance that a device is effective based upon well-controlled investigations and are also useful in assessing the weight to be given to other valid scientific evidence. The plan or protocol for the study and the report of the results of a well-controlled investigation shall include the following:. Where objective measurements of effectiveness are available and placebo effect is negligible, comparison of the objective results in comparable groups of treated and untreated patients.

Where there may be a placebo effect with the use of a device, comparison of the results of use of the device with an ineffective device used under conditions designed to resemble the conditions of use under investigation as far as possible.

clinical trials devices

Where an effective regimen of therapy may be used for comparison, e. In certain circumstances, such as those involving diseases with high and predictable mortality or signs and symptoms of predictable duration or severity, or in the case of prophylaxis where morbidity is predictable, the results of use of the device may be compared quantitatively with prior experience historically derived from the adequately documented natural history of the disease or condition in comparable patients or populations who received no treatment or who followed an established effective regimen therapeutic, diagnostic, prophylactic.

To insure the reliability of the results of an investigation, a well-controlled investigation shall involve the use of a test device that is standardized in its composition or design and performance.

The PMA application must include a discussion of the conclusions drawn from studies conducted with the medical device [ All statistical analyses used in an investigation should be appropriate to the analytical purpose, and thoroughly documented. The indications for use is based on the nonclinical and clinical studies described in the PMA. Indications for use for a device include a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.

Medical Device Clinical Trial Design and Operations

Any differences related to gender, race, ethnicity, or age, etc. The concluding discussion must present benefit and risk considerations related to the device including a discussion of any adverse effects of the device on health and any proposed additional studies or surveillance the applicant intends to conduct following approval of the PMA.

Sponsors, IRBs, and investigators, or any person acting on their behalf, are required to permit authorized FDA employees reasonable access at reasonable times to inspect and copy all records relating to clinical and nonclinical investigations.

Furthermore, if FDA has reason to suspect that adequate informed consent was not obtained or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading, FDA may inspect and copy records that identify subjects.

clinical trials devices

To assure compliance with the IDE and related regulations, FDA inspects sponsors, clinical investigators, and institutional review boards. Nonclinical laboratories that perform animal studies in which the data are used to support research or marketing permits are also included in the inspection program. The objectives of the bioresearch monitoring program are to ensure the quality and integrity of data and information submitted in support of PMA and IDE submissions and to ensure that human subjects taking part in investigations are protected from undue hazard or risk.

This is achieved through site audits of clinical data contained in PMAs prior to approval, data audits of IDE submissions, and inspections of Institutional Review Boards and nonclinical laboratories.

If your PMA includes data from a clinical trial, you must determine if your study is applicable for entry into the clinical trial registry data bank at ClinicalTrials. Based on this determination, check box 9.

An applicable device clinical trial is a prospective clinical study of health outcomes comparing an intervention with a device against a control in human subjects other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes.Study record managers: refer to the Data Element Definitions if submitting registration or results information.

This is a a randomized, controlled trial to determine the impact of the Apple Watch Series 5 compared to the Fitbit Inspire on both patient-reported outcomes and clinical utilization over 6 months and up to 1 year.

Our research method will employ a patient-centered health data sharing platform called Hugo for real-world surveillance of outcomes in total patients after they receive elective direct current cardioversion DCCV for treatment of atrial fibrillation or atrial flutter, if they have a history of atrial fibrillation.

Half of the patients will be randomized to receive the Apple Watch Series 5, while half will receive a control device Fitbit Inspire. Patients will then be queried about specific symptoms related to atrial fibrillation and medication adherence monthly. This project will provide novel and needed post-market data about the Apple Watch Series 5 ECG and irregular rhythm detection notification features and, on a larger scale, help delineate the impact of an innovative digital health technology on real-world patient outcomes.

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Specific Aim 1: To assess the impact of using the Apple Watch ECG and irregular rhythm notification features on patient-reported outcomes and clinical utilization after patients receive cardioversion for atrial fibrillation or atrial flutter, if they have a history of atrial fibrillation. Device: Apple Watch Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.

Device: Fitbit Inspire Participants will be assigned to the Fitbit Inspire arm to assess the impact of individual use of the Fitbit Inspire on patient-reported and clinical utilization outcomes using Hugo. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 6 month period. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 12 month period.

Outpatient care is defined as outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters.

The medication data will be obtained primarily from electronic health record data. Talk with your doctor and family members or friends about deciding to join a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms x. COVID is an emerging, rapidly evolving situation. Save this study. Warning You have reached the maximum number of saved studies Effect of Wearable Devices on Patient-Reported Outcomes and Clinical Utilization: A Randomized, Controlled Trial The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : July 13, See Contacts and Locations.

Study Description. This will be a prospective multi-center, randomized, controlled trial of patients conducted to assess the impact of individual use of the Apple Watch compared to the Fitbit Inspire on patient-reported and clinical outcomes at 6 months and up to 1 year.There are, however, some obvious differences when conducting clinical trials for medical devices, compared to pharmaceutical trials, which we will describe here. Medical devices are classified based on their intended use, invasiveness, duration of use, and the risks and potential harms associated with their use.

Not all medical devices will require clinical trials before they may be approved for market release. In Australia, however, all medical devices regardless of their class must comply with the Australian Regulatory Guidelines for Medical Devices ARGMDwhich includes requirements for device design and manufacturing, benefits that outweigh the risks, minimisation of risks and unwanted effects, and so forth. The approval process may require an audit and clinical evidence or data. If the idea is determined to be workable and practical proof of concept an early design of the device, known as a prototype, will be built.

Preclinical testing may involve the following:. Before a clinical trial involving a new device or drug may begin, the proposed study and device must undergo a review and notification process for the purpose of ensuring the safety of study participants:. The table below provides a side by side comparison of pharmaceutical trial phases versus medical device trial stages. The gold standard of study design for clinical trials is a randomised controlled trial, preferably with blinding and a placebo as the control.

To recap on this terminology:. This study design is often much more difficult or not possible to implement for medical devices, however. A well-controlled study design is generally acceptable. The table below compares study design elements between pharmaceutical and medical device trials:. Sham procedures are high risk and may be considered unethical. Without this kind of control, however, there is no sure way of knowing whether the device is providing real clinical benefit or if the benefit experienced is due to the placebo effect.

It is the job of the ethics committee to determine if the risks associated with a sham surgery outweigh the risk of mistaking clinical benefit for a placebo effect. This person may also be known as a technician or programmer.

They will usually be present at the implant surgery and will meet with the patient during their post-op visit to check on and activate the device. There is rarely a one-size fits all approach to programmable devices, and so this visit may take much longer than standard study visits.

Multiple programming visits are often required, whether on a regular or an as-needed basis, in order for the programmer to optimise the device and address any potential unwanted effects or adverse events. Advanced devices such as neurostimulators may also require a patient education session, which may be led by a nurse. Nurses may perform post-operative wound checks and phone calls to check on patients, however, the study coordinator will remain the primary contact person for study patients.

Other health professionals that may be involved include pathology staff i. You must be logged in to post a comment. To reduce the spread of COVID 19, we will be contacting participants before their appointments to ensure they are well. In order to protect both participants and staff, we have implemented daily temperature checking for all. This continuous monitoring is the only way to reduce the incidence of infection.

We trust you understand that we have your best interests at heart and hope you stay well.Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments such as novel vaccinesdrugsdietary choicesdietary supplementsand medical devices and known interventions that warrant further study and comparison.

Clinical trials generate data on safety and efficacy. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studiesand subsequently conduct progressively larger scale comparative studies.

Clinical trials can vary in size and cost, and they can involve a single research center or multiple centersin one country or in multiple countries.

Clinical study design aims to ensure the scientific validity and reproducibility of the results. Costs for clinical trials can range into the billions of dollars per approved drug.

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Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. Only 10 percent of all drugs started in human clinical trials become approved drugs.

Some clinical trials involve healthy subjects with no pre-existing medical conditions. Other clinical trials pertain to patients with specific health conditions who are willing to try an experimental treatment. When participants are healthy volunteers who receive financial incentives, the goals are different than when the participants are sick. During dosing periods, study subjects typically remain under supervision for one to 40 nights.

Usually, pilot experiments are conducted to gain insights for design of the clinical trial to follow. There are two goals to testing medical treatments: to learn whether they work well enough, called "efficacy" or "effectiveness"; and to learn whether they are safe enough, called "safety".

Neither is an absolute criterion; both safety and efficacy are evaluated relative to how the treatment is intended to be used, what other treatments are available, and the severity of the disease or condition. The benefits must outweigh the risks. Children and people with unrelated medical conditions are also frequently excluded.

clinical trials devices

The sponsor designs the trial in coordination with a panel of expert clinical investigators, including what alternative or existing treatments to compare to the new drug and what type s of patients might benefit.

If the sponsor cannot obtain enough test subjects at one location investigators at other locations are recruited to join the study. During the trial, investigators recruit subjects with the predetermined characteristics, administer the treatment s and collect data on the subjects' health for a defined time period.

Data include measurements such as vital signsconcentration of the study drug in the blood or tissues, changes to symptoms, and whether improvement or worsening of the condition targeted by the study drug occurs. The researchers send the data to the trial sponsor, who then analyzes the pooled data using statistical tests.

clinical trials devices

Examples of clinical trial goals include assessing the safety and relative effectiveness of a medication or device:. While most clinical trials test one alternative to the novel intervention, some expand to three or four and may include a placebo.

Except for small, single-location trials, the design and objectives are specified in a document called a clinical trial protocol.

The protocol is the trial's "operating manual" and ensures all researchers perform the trial in the same way on similar subjects and that the data is comparable across all subjects. As a trial is designed to test hypotheses and rigorously monitor and assess outcomes, it can be seen as an application of the scientific methodspecifically the experimental step.

The most common clinical trials evaluate new pharmaceutical productsmedical devices such as a new catheterbiologicspsychological therapiesor other interventions. Clinical trials may be required before a national regulatory authority [9] approves marketing of the innovation. Similarly to drugs, manufacturers of medical devices in the United States are required to conduct clinical trials for premarket approval.

An example of the former in the field of vascular surgery is the Open versus Endovascular Repair OVER trial for the treatment of abdominal aortic aneurysmwhich compared the older open aortic repair technique to the newer endovascular aneurysm repair device. Similarly to drugs, medical or surgical procedures may be subjected to clinical trials, [13] such as case-controlled studies for surgical interventions. The concepts behind clinical trials are ancient. The Book of Daniel chapter 1, verses 12 through 15, for instance, describes a planned experiment with both baseline and follow-up observations of two groups who either partook of, or did not partake of, "the King's meat" over a trial period of ten days.Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Federal Government. Read our disclaimer for details. Before participating in a study, talk to your health care provider and learn about the risks and potential benefits. Learn more. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms x. COVID is an emerging, rapidly evolving situation. Exploreresearch studies in all 50 states and in countries. Find a study all fields optional Saved Studies.

Recruiting and not yet recruiting studies All studies. Condition or disease For example: breast cancer x. Other terms For example: NCT number, drug name, investigator name x. Yemen Zambia Zimbabwe x. City x. Distance 50 miles miles miles miles. Advanced Search. Researchers Search the database to stay up to date on developments in your field, find collaborators, and identify unmet needs. Study Record Managers Learn about registering studies and about submitting their results after study completion.

National Library of Medicine U.A clinical trial is only done when there is good reason to believe that a new test or treatment may improve the care of patients.

Managing Adverse Events and Effects during Clinical Trials

Before clinical trials, tests and treatments are assessed in preclinical research. Preclinical research is not done with people. It assesses the features of a test or treatment. For example, the research may aim to learn if a device is harmful to living tissue. Another aim may be to learn more about the chemical makeup of a drug.

After preclinical research, tests and treatments go through a series of clinical trials. Clinical trials assess if tests or treatments are safe for and work in people.

Clinical trials have five phases. The phases are described next using the example of a new drug treatment:. Phase 0 trials are the first clinical trials done among people. They aim to learn how a drug is processed in the body and how it affects the body. In these trials, a very small dose of a drug is given to about 10 to 15 people.

Phase I trials aim to find the best dose of a new drug with the fewest side effects. The drug will be tested in a small group of 15 to 30 patients. Doctors start by giving very low doses of the drug to a few patients. Higher doses are given to other patients until side effects become too severe or the desired effect is seen.

If a drug is found to be safe enough, it can be tested in a phase II clinical trial. Phase II trials further assess safety as well as if a drug works. The drug is often tested among patients with a specific type of cancer. Phase II trials are done in larger groups of patients compared to Phase I trials. Often, new combinations of drugs are tested. Patients are closely watched to see if the drug works. However, the new drug is rarely compared to the current standard-of-care drug that is used.

If a drug is found to work, it can be tested in a phase III clinical trial. Phase III trials compare a new drug to the standard-of-care drug. These trials assess the side effects of each drug and which drug works better. Phase III trials enroll or more patients. Often, these trials are randomized. This means that patients are put into a treatment group, called trial arms, by chance.

Randomization is needed to make sure that the people in all trial arms are alike. This lets scientists know that the results of the clinical trial are due to the treatment and not differences between the groups.

A computer program is often used to randomly assign people to the trial arms.

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There can be more than two treatment groups in phase III trials.


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