By expanding the number of investigators and research sites conducting clinical trials, we can improve access to a greater patient population. Expanding clinical trial diversity is necessary to validate the impact of drugs on a wider range of people from different ethnicities, genders and ages. Bringing clinical trials into underprivileged or rural communities could open treatment options for people who typically haven’t had access to advanced care.
This FAQ is designed to help address some of the questions from physicians who may be considering how to get into industry-sponsored clinical trials.
It is helpful to also read the guideline for Good Clinical Practice (GCP), the international ethical and scientific quality standard for designing, conducting, recording and reporting trials involving participation of human subjects. Among other aspects, it defines the roles and responsibilities of investigators.
The investigator is the person responsible for the conduct of a clinical trial at a site. If a trial is conducted by a team of individuals, the investigator is the responsible leader of the team and may be called the principal investigator.
The investigator must ensure that the trial is executed in a way that adheres to the protocol, protects the rights and safety of patients, meets data reporting standards, and complies with regulatory requirements. You oversee the activities of the research team, administer investigational products, and review any adverse events.
A coordinating investigator is responsible for the coordination of other investigators at different centers participating in a multicenter trial.
A sub-investigator is any individual member of the clinical trial team, supervised by the investigator at a trial site. They perform critical trial-related procedures and/or make important trial-related decisions (often medical staff in more junior grades such as residents or research fellows).
Generally, clinical trial investigators are qualified physicians. GCP states that you should be “qualified by education, training and experience to assume responsibility for the proper conduct of the trial.” You do not need to be associated with a medical school or teaching hospital to qualify as a clinical investigator.
Each physician will have their own individual reasons, which could be some or all of the following:
As a clinician researcher, you are an important figure in health research. You can experience and contribute to medical innovation. You can add prestige to your practice and/or institution and contribute to advancing your medical career. While realizing that all trials carry a high potential for failure of the investigational product, you may benefit your patients by giving them access to the latest therapies. It is accepted that participation in trials benefits patients overall, irrespective of the success or failure of the new treatment. A substantial number of physicians engage in clinical trials to supplement their incomes as well as enhance their prestige, knowledge, and professional reputation.
We should start to foster a research-oriented mentality with medical students, so that the mindsight follows them into their professional careers. Another method to consider, is aligning research objectives with a physician’s medical interests. It is debatable how much financial incentives help to attract more physicians, as some aren’t motivated as much by the financial aspect. And there’s certainly a case to be made about making it easier to conduct clinical trials. Working towards this will negate the current time burden that exists, so that physicians have the time to fulfill both their clinical and research obligations.
You can start with the fundamentals of Good Clinical Practice (GCP) to understand the various guidelines, regulations and other considerations for conducting clinical trials. The FDA also offers clinical investigator training courses. Likewise, the Association of Clinical Research Professionals (ACRP) offers a range of courses as well as a certification for principal investigators. Many commercial companies also provide training courses.
It is important that you think about this ahead of time so that you can put the right investment into your research infrastructure. For example, where will you carry out procedures and conduct visits? You also need to consider what equipment you will need as well as your staffing plans. In accordance with GCP guidelines, you will need to demonstrate that you can properly carry out clinical trials and your Institutional Review Board (IRB) or Clinical Research Ethics Committee (CREC) will need to be satisfied of this.
Payment to investigators varies based on the phase of the trial, therapeutic area, duration, and patient enrollment. It covers compensation to you as the investigator as well as overhead and administration costs. It is a quite detailed topic, this Clinical Leader article provides a good introduction.
There are databases such as Clinicaltrials.gov that list both publicly and privately funded clinical trials. Searching your area of interest as well as your geography, you could find suitable trials and register your interest with contract research organizations (CROs), as sponsors may outsource clinical trial operations. You can also express your interest directly to pharma and biotech companies. When their sales representatives call to your institution you can use this as a chance to pass on your inquiries to their research departments. Finally, at Teckro we work on trials with many sponsors and we can help to connect you.
Colleagues who already run clinical trial sites in your region can be useful in providing guidance at the beginning, and their staff can be a helpful, friendly informal resource. You could also consider working with a site management organization (SMO), which is a centralized organization sponsoring several clinical sites under one umbrella. While SMOs can give you an opportunity to gain research experience, there are some financial tradeoffs to consider.
Professional associations are a good way to draw on others’ experiences. There are regional investigator registries that may present networking opportunities. One such example is the Medical Center of the Americas Foundation. You could also attend annual meetings hosted by DIA, ACRP, SCOPE and others to network and learn more about the industry.