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Clinical Research and Trials

The biggest barrier to completing studies is the shortage of people who take part. All drug and many device trials target a subset of the population, meaning not everyone can participate. Some drug trials require patients to have unusual combinations of disease characteristics. It is a challenge to find the appropriate patients and obtain their consent, especially when they may receive no direct benefit because they are not paid, the study drug is not yet proven to work, or the patient may receive a placebo. Not all of these will prove to be useful, but those that are may be delayed in getting approved because the number of participants is so low.

For clinical trials involving potential for seasonal influences such as airborne allergies , seasonal affective disorder , influenza , and skin diseases , the study may be done during a limited part of the year such as spring for pollen allergies , when the drug can be tested. Clinical trials that do not involve a new drug usually have a much shorter duration. Exceptions are epidemiological studies, such as the Nurses' Health Study.

Clinical trials designed by a local investigator, and in the US federally funded clinical trials, are almost always administered by the researcher who designed the study and applied for the grant. Small-scale device studies may be administered by the sponsoring company. Clinical trials of new drugs are usually administered by a contract research organization CRO hired by the sponsoring company.

The sponsor provides the drug and medical oversight. A CRO is contracted to perform all the administrative work on a clinical trial. For phases 2, 3 and 4, the CRO recruits participating researchers, trains them, provides them with supplies, coordinates study administration and data collection, sets up meetings, monitors the sites for compliance with the clinical protocol, and ensures the sponsor receives data from every site. Phase 1 clinical trials of new medicines are often conducted in a specialist clinical trial clinic, with dedicated pharmacologists, where the subjects can be observed by full-time staff.

These clinics are often run by a CRO which specialises in these studies. At a participating site, one or more research assistants often nurses do most of the work in conducting the clinical trial. The research assistant's job can include some or all of the following: providing the local institutional review board IRB with the documentation necessary to obtain its permission to conduct the study, assisting with study start-up, identifying eligible patients, obtaining consent from them or their families, administering study treatment s , collecting and statistically analyzing data, maintaining and updating data files during followup, and communicating with the IRB, as well as the sponsor and CRO.

Janet Yang uses the Interactional Justice Model to test the effects of willingness to talk with a doctor and clinical trial enrollment. The reasoning behind this discovery may be patients are happy with their current care. Another reason for the negative relationship between perceived fairness and clinical trial enrollment is the lack of independence from the care provider. Results found that there is a positive relationship between a lack of willingness to talk with their doctor and clinical trial enrollment.

Lack of willingness to talk about clinical trials with current care providers may be due to patients' independence from the doctor. Patients who are less likely to talk about clinical trials are more willing to use other sources of information to gain a better insight of alternative treatments.

Clinical trial enrollment should be motivated to utilize websites and television advertising to inform the public about clinical trial enrollment. The last decade has seen a proliferation of information technology use in the planning and conduct of clinical trials. Clinical trial management systems are often used by research sponsors or CROs to help plan and manage the operational aspects of a clinical trial, particularly with respect to investigational sites.

Advanced analytics for identifying researchers and research sites with expertise in a given area utilize public and private information about ongoing research. Interactive voice response systems are used by sites to register the enrollment of patients using a phone and to allocate patients to a particular treatment arm although phones are being increasingly replaced with web-based IWRS tools which are sometimes part of the EDC system.

While patient-reported outcome were often paper based in the past, measurements are increasingly being collected using web portals or hand-held ePRO or eDiary devices, sometimes wireless. Access to many of these applications are increasingly aggregated in web-based clinical trial portals.

Summary points

In , the FDA approved a phase 1 trial that used telemonitoring, also known as remote patient monitoring, to collect biometric data in patients' homes and transmit it electronically to the trial database. This technology provides many more data points and is far more convenient for patients, because they have fewer visits to trial sites. Clinical trials are closely supervised by appropriate regulatory authorities. All studies involving a medical or therapeutic intervention on patients must be approved by a supervising ethics committee before permission is granted to run the trial.

The local ethics committee has discretion on how it will supervise noninterventional studies observational studies or those using already collected data. To be ethical, researchers must obtain the full and informed consent of participating human subjects. One of the IRB's main functions is to ensure potential patients are adequately informed about the clinical trial. In California , the state has prioritized the individuals who can serve as the legally authorized representative.

In some US locations, the local IRB must certify researchers and their staff before they can conduct clinical trials. The International Conference of Harmonisation Guidelines for Good Clinical Practice is a set of standards used internationally for the conduct of clinical trials. The guidelines aim to ensure the "rights, safety and well being of trial subjects are protected". The notion of informed consent of participating human subjects exists in many countries all over the world, but its precise definition may still vary.

Informed consent is clearly a 'necessary' condition for ethical conduct but does not 'ensure' ethical conduct. In compassionate use trials the latter becomes a particularly difficult problem. The final objective is to serve the community of patients or future patients in a best-possible and most responsible way. See also Expanded access. However, it may be hard to turn this objective into a well-defined, quantified, objective function. In some cases this can be done, however, for instance, for questions of when to stop sequential treatments see Odds algorithm , and then quantified methods may play an important role.

Additional ethical concerns are present when conducting clinical trials on children pediatrics , and in emergency or epidemic situations. In response to specific cases in which unfavorable data from pharmaceutical company-sponsored research were not published, the Pharmaceutical Research and Manufacturers of America published new guidelines urging companies to report all findings and limit the financial involvement in drug companies by researchers.

Drug researchers not directly employed by pharmaceutical companies often seek grants from manufacturers, and manufacturers often look to academic researchers to conduct studies within networks of universities and their hospitals, e. Similarly, competition for tenured academic positions, government grants and prestige create conflicts of interest among academic scientists.

In the United States, all clinical trials submitted to the FDA as part of a drug approval process are independently assessed by clinical experts within the Food and Drug Administration, [62] including inspections of primary data collection at selected clinical trial sites. In , the editors of 12 major journals issued a joint editorial, published in each journal, on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to review the studies prior to publication and withhold publication.

They strengthened editorial restrictions to counter the effect. Researchers may be restricted from contributing to the trial design, accessing the raw data, and interpreting the results. Responsibility for the safety of the subjects in a clinical trial is shared between the sponsor, the local site investigators if different from the sponsor , the various IRBs that supervise the study, and in some cases, if the study involves a marketable drug or device , the regulatory agency for the country where the drug or device will be sold.

For safety reasons, many clinical trials of drugs [65] are designed to exclude women of childbearing age, pregnant women, or women who become pregnant during the study. In some cases, the male partners of these women are also excluded or required to take birth control measures. Throughout the clinical trial, the sponsor is responsible for accurately informing the local site investigators of the true historical safety record of the drug, device or other medical treatments to be tested, and of any potential interactions of the study treatment s with already approved treatments.

This allows the local investigators to make an informed judgment on whether to participate in the study or not. The sponsor is also responsible for monitoring the results of the study as they come in from the various sites as the trial proceeds. In larger clinical trials, a sponsor will use the services of a data monitoring committee DMC, known in the US as a data safety monitoring board. This independent group of clinicians and statisticians meets periodically to review the unblinded data the sponsor has received so far.

The DMC has the power to recommend termination of the study based on their review, for example if the study treatment is causing more deaths than the standard treatment, or seems to be causing unexpected and study-related serious adverse events. The sponsor is responsible for collecting adverse event reports from all site investigators in the study, and for informing all the investigators of the sponsor's judgment as to whether these adverse events were related or not related to the study treatment.

The sponsor and the local site investigators are jointly responsible for writing a site-specific informed consent that accurately informs the potential subjects of the true risks and potential benefits of participating in the study, while at the same time presenting the material as briefly as possible and in ordinary language. FDA regulations state that participating in clinical trials is voluntary, with the subject having the right not to participate or to end participation at any time.

The ethical principle of primum non nocere "first, do no harm" guides the trial, and if an investigator believes the study treatment may be harming subjects in the study, the investigator can stop participating at any time. On the other hand, investigators often have a financial interest in recruiting subjects, and could act unethically to obtain and maintain their participation. The local investigators are responsible for conducting the study according to the study protocol, and supervising the study staff throughout the duration of the study.

In other words, they or their legally authorized representatives must give truly informed consent. Local investigators are responsible for reviewing all adverse event reports sent by the sponsor. These adverse event reports contain the opinion of both the investigator at the site where the adverse event occurred, and the sponsor, regarding the relationship of the adverse event to the study treatments. Local investigators also are responsible for making an independent judgment of these reports, and promptly informing the local IRB of all serious and study treatment-related adverse events.

When a local investigator is the sponsor, there may not be formal adverse event reports, but study staff at all locations are responsible for informing the coordinating investigator of anything unexpected. The local investigator is responsible for being truthful to the local IRB in all communications relating to the study. Approval by an Institutional Review Board IRB , or ethics board, is necessary before all but the most informal research can begin. In commercial clinical trials, the study protocol is not approved by an IRB before the sponsor recruits sites to conduct the trial.

However, the study protocol and procedures have been tailored to fit generic IRB submission requirements. In this case, and where there is no independent sponsor, each local site investigator submits the study protocol, the consent s , the data collection forms, and supporting documentation to the local IRB. Universities and most hospitals have in-house IRBs. Other researchers such as in walk-in clinics use independent IRBs. The IRB scrutinizes the study for both medical safety and protection of the patients involved in the study, before it allows the researcher to begin the study.

It may require changes in study procedures or in the explanations given to the patient. A required yearly "continuing review" report from the investigator updates the IRB on the progress of the study and any new safety information related to the study. In the US, the FDA can audit the files of local site investigators after they have finished participating in a study, to see if they were correctly following study procedures. This audit may be random, or for cause because the investigator is suspected of fraudulent data. Avoiding an audit is an incentive for investigators to follow study procedures.

A 'covered clinical study' refers to a trial submitted to the FDA as part of a marketing application for example, as part of an NDA or k , about which the FDA may require disclosure of financial interest of the clinical investigator in the outcome of the study. For example, the applicant must disclose whether an investigator owns equity in the sponsor, or owns proprietary interest in the product under investigation. The FDA defines a covered study as " Alternatively, many American pharmaceutical companies have moved some clinical trials overseas.

Benefits of conducting trials abroad include lower costs in some countries and the ability to run larger trials in shorter timeframes, whereas a potential disadvantage exists in lower-quality trial management. Beginning in the s, harmonization of clinical trial protocols was shown as feasible across countries of the European Union. At the same time, coordination between Europe, Japan and the United States led to a joint regulatory-industry initiative on international harmonization named after as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH [70] Currently, most clinical trial programs follow ICH guidelines, aimed at "ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner.

These activities are pursued in the interest of the consumer and public health, to prevent unnecessary duplication of clinical trials in humans and to minimize the use of animal testing without compromising the regulatory obligations of safety and effectiveness. Aggregating safety data across clinical trials during drug development is important because trials are generally designed to focus on determining how well the drug works. The safety data collected and aggregated across multiple trials as the drug is developed allows the sponsor, investigators and regulatory agencies to monitor the aggregate safety profile of experimental medicines as they're developed.

The value of assessing aggregate safety data is: a decisions based on aggregate safety assessment during development of the medicine can be made throughout the medicine's development and b it sets up the sponsor and regulators well for assessing the medicine's safety after the drug is approved. Clinical trial costs vary depending on trial phase, type of trial, and disease studied. The cost of a study depends on many factors, especially the number of sites conducting the study, the number of patients involved, and whether the study treatment is already approved for medical use.

The expenses incurred by a pharmaceutical company in administering a phase 3 or 4 clinical trial may include, among others:. In the US, sponsors may receive a 50 percent tax credit for clinical trials conducted on drugs being developed for the treatment of orphan diseases. In these cases, the investigator who writes the grant and administers the study acts as the sponsor, and coordinates data collection from any other sites. These other sites may or may not be paid for participating in the study, depending on the amount of the grant and the amount of effort expected from them.

Using internet resources can, in some cases, reduce the economic burden. Investigators are often compensated for their work in clinical trials. These amounts can be small, just covering a partial salary for research assistants and the cost of any supplies usually the case with national health agency studies , or be substantial and include 'overhead' that allows the investigator to pay the research staff during times between clinical trials. Participants in phase 1 drug trials do not gain any direct health benefit from taking part.

They are generally paid a fee for their time, with payments regulated and not related to any risk involved. In later phase trials, subjects may not be paid to ensure their motivation for participating with potential for a health benefit or contributing to medical knowledge. Small payments may be made for study-related expenses such as travel or as compensation for their time in providing follow-up information about their health after the trial treatment ends. Phase 0 and phase 1 drug trials seek healthy volunteers.

Most other clinical trials seek patients who have a specific disease or medical condition. The diversity observed in society should be reflected in clinical trials through the appropriate inclusion of ethnic minority populations. All volunteers being considered for a trial are required to undertake a medical screening. Requirements differ according to the trial needs, but typically volunteers would be screened in a medical laboratory for: [82]. It has been observed that participants in clinical trials are disproportionately white. This may reduce the validity of findings in respect of non-white patients.

Depending on the kind of participants required, sponsors of clinical trials, or contract research organizations working on their behalf, try to find sites with qualified personnel as well as access to patients who could participate in the trial. Working with those sites, they may use various recruitment strategies, including patient databases, newspaper and radio advertisements, flyers, posters in places the patients might go such as doctor's offices , and personal recruitment of patients by investigators. Volunteers with specific conditions or diseases have additional online resources to help them locate clinical trials.

For example, the Fox Trial Finder connects Parkinson's disease trials around the world to volunteers who have a specific set of criteria such as location, age, and symptoms. The risk information seeking and processing RISP model analyzes social implications that affect attitudes and decision making pertaining to clinical trials.

Cancer patients reported more optimistic attitudes towards clinical trials than the general population. Having a more optimistic outlook on clinical trials also leads to greater likelihood of enrolling. From Wikipedia, the free encyclopedia. For the journal, see Clinical Trials journal. Main article: Phases of clinical research. Main article: Clinical study design. Main article: Clinical trial protocol.


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