Establishing a Clinical Trials Practice

Running a clinical trial requires extra training, staff, and equipment, and it can be complicated to get started; however, the advantages are numerous. You can learn about and keep abreast of therapeutic and/or device advances in dermatology treatments before everyone else, and your patients who participate in the trial will also possibly be able to try something that will not be available to the public for 4 or 5 years if approved by the US Food and Drug Administration (FDA). You also gain the unique advantage of being able to educate other dermatologists about the new advances because you have already been working with the product for several years. In this article, I will answer frequently asked questions for those interested in establishing a clinical trials practice.

How Do I Get Started With Clinical Trials? 
 

Because trials are complicated and multifaceted to get up and running, the easiest way to start is to get help. If you have never run clinical trials, there are companies that will bring them in to your practice, set them up, and then run them for you. Depending on the contract you have with them, some of these companies will want to own your clinical trials practice, which means paying you as an employee, whereas others may allow you to retain ownership of the clinical trials practice, but they receive a significant percentage of the profits. These companies take all the worry out of learning how to conduct clinical trials because they handle everything from A to Z. They set you up, provide all the equipment you need, tell you what type of training you need and how to get patients into clinical trials, and even find you the clinical trials. They also negotiate the budget and can hire staff for you and find patients to participate. Keep in mind, the contract can last for several years, and you are locked in for the duration, which means you will be unable to run a clinical trials practice on your own during that time. On the other hand, you are learning how to run one on your own while the company does everything for you and takes care of all of your trial needs. If you are just getting started, this seems like a great way to start. Although you will certainly make extra income, you will not earn as much money as you would if you completely ran and owned your own active clinical trials practice. But this is a path to learn the nitty-gritty of how to recruit for and run clinical trials.

Conversely, starting your own clinical trials practice often takes years of connections and networking. The first thing that you need to do is network with the people who work in the medical affairs or research and development (R&D) departments at pharmaceutical companies. Medical affairs and R&D are the people who can help you with clinical trials because they know what clinical trials the pharmaceutical company is currently performing, what will be conducted soon, and what is coming up potentially farther down the line. For me, it took a few years of networking before I was able to land my first clinical trial. You will also need to have a good recruiting base of patients who would be interested in the clinical trial rather than using their own insurance. If not, you will need to create an advertising budget to help recruit for whatever clinical trial you are doing.

Another, perhaps more significant, way of finding clinical trials is working with clinical research organizations (CROs), which are hired by the pharmaceutical companies to run their clinical trial. In other words, pharmaceutical company A usually does not want to be directly involved in running its clinical trial, so the trial is not seen as being biased. Pharmaceutical company A pays the CRO a lump sum and the CRO takes care of all aspects of the clinical trial from there, and this includes finding investigators to run the trial. Once you have established relationships with the pharmaceutical companies, getting to know the CROs is important because they can also send you clinical trials, especially if they know you complete things on time and provide good data.

Do I Need Extra Training to Run Clinical Trials?
Every clinical trial requires different types of training for all staff, including the investigator, sub-investigator, and ancillary staff. Each trial has a different set of rules, so there is always associated online or in-person training on the protocol. All staff members must get trained on every detail of the protocol, along with completing trainings on equipment and the evaluations that will be used for each study. The investigator must also complete the relevant equipment and evaluation trainings. In addition, the investigator must complete training and then prove competence via evaluations in every investigator assessment that is contained in the protocol. For example, in psoriasis studies, there is training in pertinent assessment scales, such as the Physician Global Assessment and Psoriasis Area and Severity Index scoring. Even if you have done it a million times, it is necessary to complete training every time.

In addition, every 2 years, everyone who runs clinical trials in your office must be certified in good clinical practice, or GCP, guidelines. These are ethical principles and the rules that must be followed when performing clinical trials.

Do I Need Extra Staff to Run Clinical Trials?
You must have dedicated staff to run clinical trials. Usually, you will need to have almost 1 staff member for every clinical trial. For example, if you are running 4 clinical trials at the same time, you need 3 to 4 full-time staff members just to be dedicated to those trials. You must negotiate a budget for every clinical trial you do, and that budget encompasses everything from the equipment and supplies you will need to the amount the investigator and study coordinators get per assessment. In addition, every practice must develop standard operating procedures (SOPs) for a variety of potential scenarios, such as what happens if a patient has to go to the hospital. You are expected to have a set of SOP guidelines written up for possible adverse scenarios that can occur in the trial center. And all of this paperwork takes extra staff hours.

What Kind of Equipment Do I Need for Clinical Trials?
First, you need space to run a clinical trial that can be closed off so only those authorized have access to it. Dedicated storage facilities, such as locked closets and cabinets for supplies and any records you have in the office that you use in clinical trials, are also needed. In general, everyone needs computers and good internet service because it is sometimes a problem if you cannot transmit data quick enough, especially with large, high-quality photos or videos that need to be uploaded. There is also certain equipment that you are required to have for clinical trials in your office, such as different types of centrifuges. We have a -20° C freezer, a regular freezer, and a refrigerator, and these must always be locked. We also have an electrocardiogram (ECG) machine because ECGs are required for many trials, but if your office does not own one, it may be sent to you temporarily.

How Much Money Can I Make Doing Clinical Trials?
Clinical trials can be lucrative, but they are a lot of extra work. The more complicated the medication or treatment, the more complex, but also higher paying, the budget you will negotiate usually is. Generally, studies with creams are of shorter duration and pay less then biologics and newer technology studies. Keep in mind the dedicated time you will need to spend, including after-hours time signing off on material such as labs. For example, you must sign off on every blood test for every patient to ensure that it is not falling outside the parameters, and labs usually require a sign off on every page. Imagine if you have 1 trial with 10 participants, a second trial with 20 participants, and a third trial with another 10 participants and labs are done every 2 weeks. For those 40 patients, you are looking at hundreds of signatures every month, and that is just for the labs alone. In addition, every clinical trial sends a monitor to your site once a month or so to make sure you are doing everything according to protocol, which also requires your time, as well as your staff members’ time.

Can I Publish From Doing Clinical Trials?
If you are doing a trial for a pharmaceutical company through a CRO, they own all the data, which is part of the clinical trial agreement you sign, so the answer is “no.” If you do well in a particular clinical trial, you can ask if you can be part of any publications that come out of it. That is up to the pharmaceutical company, but they can put you on some of their publications if you express interest.  An investigator-initiated study (IIS) gives you the chance to publish on your own. An IIS is usually done to see if already approved FDA medications can be used in a novel way. For an IIS, you write the entire protocol and submit a proposal through a pharmaceutical company’s web portal. If your IIS is approved by the pharmaceutical company, you run the trial and can publish any of the results.

The Takeaway
If you are interested in starting with clinical trials, the best advice I can give is to get with someone who has experience running clinical trials and work with them. If you are part of a big dermatology group, there are probably people in your group who have experience and maybe you can be part of the group’s clinical trials. If you are in private practice and not part of a big group, I suggest you reach out to some of the pharmaceutical company’s medical affairs people and express your interest. It is important to keep networking with pharmaceutical companies and CROs to keep your clinical trials practice active. Clinical trials are not for clinicians who do not want to put in extra time outside the office, but if you are someone who enjoys the work, you will benefit from becoming familiar with therapeutic advances for several years before they are FDA approved, and so will your patients.