Science or Not?
October 14, 2018 2:10 PM   Subscribe

Who is qualified to conduct clinical trials? What are clinical trials?

I have met some people over the years in my community who do clinical trials. I'm wondering what this is and what are the qualifications to conduct clinical trials.

What is a clinical trial assistant? What education is required for a clinical trial assistant? What is contracted research and development?

It seems that drug companies use clinics and doctor offices to conduct clinical trials, or drug studies. I'm thinking of dialyis centers, and I know of a cardiologist in town who is always doing "drug studies". Are these trials or studies paid for by pharmaceutical companies? What is the difference between a study and a trial and what kind of people work in the clinical trial field.

It seems that some research companies or clinical trial places have offices all over the country. Some are very specialized as in renal failure. What is this?
posted by loveandhappiness to Work & Money (8 answers total) 3 users marked this as a favorite
 
For basic information about clinical trials in the USA, take a look at the National Institutes of Health Clinical Trails website.
posted by sciencegeek at 2:24 PM on October 14, 2018 [6 favorites]


The link that sciencegeek linked to is a good one: it's the National Library of Medicine's definitions for Clinical Trials (and what needs to be registered at ClinicalTrials.gov).

At the moment, there's an effort by NIH to expand the scope of "clinical trials" in ways that really don't make sense - for example, under the current interpretation, pretty much anything you do with human subjects might be a clinical trial, even if it's as unclinical as, say, making participants bored by having them look for Ts among Ls on a screen. It's a big mess at the moment for the basic research community, and I'm involved in pushing back against NIH's approach here - we need good clinical trials, and we probably want all research to register and report what's done, but not everything is a clinical trial.
posted by Making You Bored For Science at 3:02 PM on October 14, 2018 [1 favorite]


Doctors supervise clinical trials, but much work is done by other types of professionals, called clinical research associates.
posted by Ausamor at 4:12 PM on October 14, 2018


[Link removed from post; assuming all good intent, there's still zero reason to include a link to a spammy-looking pharma blog.]
posted by cortex (staff) at 4:19 PM on October 14, 2018 [2 favorites]


Sciencegeek's link to NIH is a really good introduction to how clinical studies and trials work (a trial is a particular kind of study, but studies include more things than trials). I am a PhD microbiologist who works on clinical trials for a biotechnology company, and so what I'm saying from here on out is from the perspective of a scientist who is heavily involved in clinical research at a drug company, where we are hoping to put a new drug on the market (for a rare infectious disease!).

Generally speaking, there are two major ways that a trial or study might be paid for and run. The first is what is called an "investigator-initiated" trial. In this case, a doctor has an idea that they want to learn more about, and that doctor is in charge of talking to lots of different groups to get permission and money to do their study. The second is what is called a "sponsor-initiated" trial. In a sponsor-initiated trial, a drug or medical device company is in charge of deciding what they want to study, finding the money to run the study, and getting permission to do the study.

Two big groups of people are in charge of whether a study happens. The first (in the US) is the Food and Drug Administration (in the EU it's the European Medicines Association, in Canada it's Health Canada, etc). The FDA/gov't regulatory agency is concerned, above all, with determining whether it's safe to run your study (or if your drug is super new and you don't know much about safety in humans yet, they're checking that you're being careful enough). To run a trial of a new drug (something your doctor can't just prescribe you, that you can't get at the pharmacy yet), you have to file what is called an Investigational New Drug (IND) application. And you have to submit your protocol (instructions on how the study will be done) to the FDA as well. You have to talk to the FDA about the kind of information you want to collect, and how you're going to analyze that information. The second group is called an IRB, or Institutional Review Board. These are the people who are in charge of making sure that the people who participate in your study are being treated ethically, and understand what they're agreeing to do, and understand that they can stop doing the study whenever they like.

As to how a study actually happens, well, there are A LOT of layers. In the case of an investigator-initiated study, the doctor who designed the trial may be treating patients in the trial themselves - it's their existing patients. They probably have staff, including a Clinical Trial Associate or Clinical Research Coordinator, who makes sure data entry is done properly, and appointments are scheduled at the right time, and paperwork is filed properly. CTAs/CRCs don't need more than a bachelor's degree, an exceptional attention to detail, and a desire to serve patients to be exceptional at their work (which is VERY well paid on the sponsor side of things, btw, especially if someone grows into management). For a sponsor-initiated study, the sponsor (drug company) may hire what's called a Contract Research Organization to do the study logistics, or they might do the logistics themselves. But they'll have many many "sites" for the study - these are doctors around the country/world who enroll patients in the trial, follow the study protocol, collect data, and otherwise participate in the study. These doctors will have CTAs/CRCs employed in their practice.

And yes, there are doctors and medical practices who focus on enrolling patients in clinical trials. They will sometimes focus on certain disease areas, like you've noticed - if a doctor has specialized their own training in renal diseases, they will be well-suited to working on studies of drugs for renal diseases: they understand the patient population, they know what has and hasn't worked in the past, they understand the science of a new drug and can decide which ones they think are promising and which ones they don't think are right for their own patients. Drug companies pay a fee to a site for every patient that is enrolled in a study, and with good reason - providing the appropriate amount of attention to a patient in a study to make sure that they are safe, and to collect all of the required data, takes a HUGE amount of a doctor's time.
posted by amelioration at 4:46 PM on October 14, 2018 [6 favorites]


What is the difference between a study and a trial

A “study”, among scientists and medical researchers, can be almost any scholarly investigation of a topic. There are case studies, statistical analyses of other work, modeling studies, etc.

The term ‘clinical trial’ is part of what is called controlled vocabulary, it has explicitly defined meaning in some formal scheme of terminology, in this case a scheme defined by the NIH and many others.

A clinical trial is a specific type of study. To my knowledge, “study” it is almost always used in a general sense, and it applies to zillions of things that are not clinical trials, but are still part of the research process.
posted by SaltySalticid at 6:09 PM on October 14, 2018


Clinical trials are usually run by/supervised by physicians, who may have an MD/PhD, or an MD + other training in clinical trials such as a Masters in Clinical Research. In the US, they are usually funded by NIH, pharma/device companies, or disease foundations such as the American Cancer Society or the Michael J Fox Foundation. Given the costs and paperwork involved with an IND, trials evaluating new drugs/devices are usually funded by the companies with an interest in bringing the drug/device to market; foundations and the NIH more often fund investigator-initiated work using things that are already available. There are, of course, exceptions.

The design of a clinical trial can range anywhere from the "gold standard" double-blind placebo-controlled randomized clinical trial, to an observational study tracking a group of people ("cohort") over time. Retrospective chart analysis or database analysis is not usually considered a clinical trial, even by the NIH's stringent criteria.

The staff involved in the trial include the steering committee (for a multi-center trial) who make sure that every site is on the same page, one or more site Principal Investigator/co-PIs who supervise events at their site and are responsible for the subjects enrolled at that time, and one or more study coordinators who do much of the actual data collection and data entry. Good clinical trials should also have a statistician involved at some point, usually for trial design and analysis of results. The physicians who refer their patients for a trial are not considered part of the study team (unless they also happen to be the site PI/co-PI). Study visits and any labs/imaging required for the study are paid for by the sponsor (pharma/NIH/foundation). Physicians who refer their patients for the study are not part of the study team and are explicitly not allowed to get kickbacks or brownie points for referrals, but for the site PI/co-PI, a portion of their time (whatever is needed for the study analysis) and possible travel funds to present results at a conference, may be covered by the sponsor.
posted by basalganglia at 5:13 AM on October 15, 2018


Thank you all. All great answers. I am better informed and now have a grasp on clinical trials. Thanks again.
posted by loveandhappiness at 2:50 PM on October 15, 2018


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