The primary goal of the biotechnology and pharmaceutical industry is to develop medications and medical devices for the treatment of patients, while earning financial gain for investors. An important component of achieving this goal is the role physicians play in the drug and medical device development process. In particular, a physician’s role is to combine their clinical expertise with their knowledge of industry products to better diagnose and treat the ailments of their patients. Thus, medicine and industry have a dependent relationship. In recent times this relationship has been fraught with turmoil as the public, scientific community, and federal government have discovered real and perceived conflicts of interest.
For example, there has been public outrage in the past with reports of doctors receiving gifts, money, and lavish trips in return for prescribing medications or using certain medical devices. Because of this, Congress passed the Sunshine Act, deeming it necessary to report all physician and industry engagements that have any perceived financial value. The passage of this act was in addition to local policies set forth by academic institutions, hospitals, and private practices.
Dr, Nitin Gupta
How Do I Get Started?
After checking with your institution, hospital or private practice administrator, the first step is to reach out to a local representative (“rep”) of a pharmaceutical or biotech company in which you are interested. You can accomplish this via the website of the company or by visiting the booth at major gastrointestinal conferences such as Digestive Disease Week (DDW®).
Pharma and device reps are quite knowledgeable about the latest clinical studies regarding their products, disease states, and various competing products in the market. In addition to being a source of valuable medical knowledge and disease-specific practice guidelines, they also can connect you with their medical science liaison (MSL). MSLs often have a background in pharmacy and/or research. Thus, they can provide insights into mechanisms of disease treatments and go beyond discussion of the product label, which pharmaceutical reps adhere to. They also know what therapies or diagnostic tools are in the phases of development and could be available for a clinical trial.
MSLs are also the gatekeepers for Investigator Initiated Studies (IIS). An IIS is a research project that is industry-funded and is solely designed and executed by the clinician. The application process is rigorous but awards may be easier to obtain for non-research-based clinicians who want to develop a disease-specific project that needs funding. Their grant application process can be brief, ideas may not require prior data, and turnaround time to funding may be shorter. IISs often lead to exploratory findings that may facilitate publications or lay groundwork for large-scale grants or even clinical trials. In some instances, you may be granted access to internal data and prescribing patterns, which can answer interesting clinical and research questions.
How Do I Get Started with Clinical Trials?
Being a primary investigator on a clinical trial is a big responsibility. You are responsible to the trial sponsor in addition to your patients. For young clinicians who lack experience with clinical trials, the first thing to do is to find a clinician in your department or another department, who has expertise in performing an industry-sponsored study. These individuals can be invaluable for you in terms of guiding you through the study feasibility process, study startup, and possibly being the lead or co-investigator with you. Partnering with someone with expertise in industry-sponsored clinical trials will help you gain the trust of the industry sponsor, which may be a requirement for some.
There are many additional requirements that need to be fulfilled aside from just having an appropriate and adequate patient population to pull from. You will need to have a coordinator for the study who will help you with patient care, data entry, and study- specific issues. Clinical trials require a significant amount of documentation and reporting that has to be performed within a timely manner. There is no degree prerequisite of the coordinator but it can simplify things for the clinician if they have a RN or LPN degree. Having such a degree will facilitate dual roles of patient care, lab draws, drug administration, medical charting, and other patient care matters.
In addition, you will need to have approval from either your local or central institutional review board (IRB). Also, you will have to review budget and study-specific requirements for equipment and infrastructure with your department manager. You will need to demonstrate adequate ancillary support to process, store, and ship biological specimens. In some instances, you will need a dedicated pharmacist to mix or dispense study drugs.
The process is lengthy and involved, but rewarding in terms of being involved in the drug development process. You will have opportunities to attend meetings at which you can network with other clinicians and provide the sponsor feedback on how the study is going.
