Here are some points to consider:
- First, think like a medical device company. By and large, companies are usually the ones funding the research. They want to save costs since many companies have limitations to their research budgets. Every step in clinical research, from the design of the trial to the support documentation and prototype patient consent form(s) should be carefully assembled to reduce delays in approval from an hospital's investigastional review board (IRB). Months of delays with IRB's can occur without this documentation and remember, time is money. An acceptable number of patients with the studied ailment must also be seen at your institution. For instance, if the trial requires congenital heart disease patients and your clinic only sees ten of these patients a quarter, you will probably find the trial will be completed before your center has an opportunity to enroll even a single patient. In return, you get nothing more than the enjoyment of completing tons of paperwork.
- Make sure your center can afford the trial. All research centers require budgets. Most require an itemization of direct costs and then an overhead fee for "indirect costs" (think lights, heating, facilities charges, etc). These costs cut both ways: centers that have "indirect costs" that are excessive will never be approached by companies for research work (unless they are suicidal) and likewise, companies that don't offer some amount for these real-life expenses to conduct the work, shouldn't be performed at your center. Working out the budget needs BEFORE the research is submitted to the IRB will save countless hours of work in the end.
- Learn to write. Most doctors are great at math and science, but far fewer are skilled at writing. The most productive researchers I have met are not only good doctors, but great writers as well. They can construct an organized research paper complete with a thorough literature review on their first pass. Learn this skill and you will be a highly sought-after researcher.
- Be a cheerleader. Patients have to believe in the work and so do your referring doctors. If you can't articulate the importance of the trial to these folks, you'll never be successful. Also, since trials take time, keeping your trial at the forefront of your collegue's minds will be one of the toughest challenges that any young researcher will encounter. Other doctors will not have the passion or commitment for your work, so frequent reminders about your trial (along with follow-up on patients that are enrolled) will go a long way to improve trial enrollment. Again, time is money.
- Be prepared to work after hours. The days of sheltered research time have long since passed. In today's clinical environment, you'll still need to see your usual cauldron of clinic and procedural patients, lest your clincal productivity (and maybe your salary) suffer. While some clinical trials can increase your clinic volume as patients are referred for evaluation in trials, this is usually not the norm.
- Be timely at returning e-mails and phone calls. Believe it or not, corporate time is just as important as yours.
- Be transparent. In today's world, it is not okay to keep your relationships with a device company private. Tell everyone what you're doing and how much you make doing it (they'll find out anyway). If a speaking or consulting junket sounds too good to be true, avoid it. Sticking to this advice will help keep your clinical research career not only viable, but fruitful, for years to come.
- Get help. In today's regulatory environment, the number and scope of rules for research are greater than ever. Many centers have people that can help young investigators stay out of trouble. Find out who these people are and use them. Often.
Hi Dr. Wes, my name is Diego Salfate, from Chile. I'm a Second year Medical Student. I think your blog is very interesting, because your post give a lot of experience to the people; particularly this article, because you expose a points to considerate for to dedicate to the Clinical Investigation, and with this help could have been careful in the course of the investigation.
Thanks for your time Dr. Wes
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