What Pharma Can Do To Make Clinical Research Easier For New PI’s To Participate?
This post will be about how the pharmaceutical industry in general can make clinical research more worthwhile of a pursuit for brand new sites, and as a consequence, new Principal Investigators, to get started in this business and to continue thriving in the long term.
As mentioned in the last post, most PIs who have never done a study before and start with their first study, never do another one. This is a huge problem because it is directly related to the lack of adequate patient enrollment, which leads to delayed and costlier studies because the doctors who have all the patients to enroll don’t want to participate in clinical research themselves. The big picture is better treatments are not getting into the market on time. Clinical trials are costlier, slower and not as efficient as they can be. The high amount of PIs not returning to do another study is in fact a big problem. Physicians that have a high volume of patients would be able to help recruit qualified study patients into clinical studies and they would be much more motivated to do so if they were the principal investigators of their own research sites. These physicians should be doing clinical trials. The irony is that physicians that are typically doing clinical trials do not see enough patients in the “real world” in order to be effective at enrolling subjects into the studies while physicians that are NOT doing trials have a high volume of potential patients that will sadly never get enrolled into (or even made aware of) a clinical trial.
Pharma can definitely help solve some, if not most, of this dilemma. One thing pharma and CRO’s created was the “gold standard” of clinical research clinics, sites they established relationships with and helped develop into successful research sites . They started doing this back in 2012 when CROs birthed the idea of a “preferred site model”. The CROs primarily did this so they can market themselves as having a more “hands on” exclusive relationship with their sites, thus selling the idea to sponsors that they should choose them to run their study because they had a list of these valuable sites. This also allowed CROs to claim that their sites have experienced physicians as PIs who can refer a high volume of patients quickly for their particular studies.
Sponsors recently have tried breaking down some physician barriers to participating in clinical research studies, most notably through the Transcelerate initiative as well as the emergence of drugdev.org which is essentially a network of investigator portals where investigators can sign up to be notified of studies that they might be interested in participating in. To learn more aboutdrugdev.org please check out my interview with their CEO here https://www.youtube.com/watch?v=oc1Zm_qcc3M . This website matches physicians who are interested in research with the studies that are available. Sponsors can also help the research industry by creating less intimidating studies (such as phase 4 studies) and approach physicians who expressed interest in doing clinical research but have never before participated in order to get their feet wet. Phase 4 studies are studies on drugs that are already approved by the FDA but more data still may be needed. Creating easier studies for inexperienced physicians can allow these physicians to gain crucial experience in research while also encouraging them to participate in other studies.
Another thing pharma can do a better job of is to use their existing infrastructure of sales reps to educate physicians about research opportunities. The sales reps should discuss their companies’ current research studies and be proactive about informing physicians about upcoming medications that are to arrive in the marketplace in the near future. A medical liaison is an individual at the pharma company (usually a pharmacist or another physician) who coordinates between sales team and the research and development team within the pharmaceutical company. These individuals are literally at the intersection of sales and research, and are a perfect candidate for exploring clinical research opportunities with the physicians in their territories. I always push my clinics to find their medical liaisons for every drug company sales rep that ever visits their offices. This relationship will give you opportunities to find out more about researches that are available to your site.
A lot of physicians have the misconception that clinical research is solely conducted in academic institutions or non-profit organizations. They likely have no idea that their colleagues are doing clinical research right out of their private practice offices, generating additional streams of revenue and have insight on the new medications that are about to hit he market.
Finally, the Sunshine Act is a big deterrent for physicians to get involved in clinical research. The Sunshine Act essentially makes all the money being paid by pharma companies to research sites publicly available, but instead of listing the research site as the rightful recipient, they list the principal investigator as the recipient of the entire gross amount of the funds paid out to the site even if the investigator did not profit the majority of the funds for himself. Remember, research clinics incur numerous expenses such as study coordinator and administrative personnel salary, overhead and the like (see previous blog post for more details). Yes, I understand that it is important to have transparency and we do need to disclose pharma payments to physicians, especially when it comes to marketing and sales. However, the Sunshine Act includes clinical research gross revenue as a direct payment to the principal investigator of that clinic, therefore grossly exaggerating and misleading the public on how much the physician actually profited from his involvement in the trial. Sometimes the PI is not the owner of the research clinic but simply an employee or an independent contractor. The Sunshine Act nevertheless shows the gross revenue of the research clinic as a direct payment to the PI. This results in an inflated amount of the actual payment to the physician from the drug companies when in reality, this payment occurred on paper alone. If we can somehow change the technical reporting requirements in the Sunshine Act to correctly list the name of the clinical research site instead of the PI as the payee of a particular study, I believe more PI’s will be comfortable participating in research trials.
A lot of pharma companies need to understand that the physicians who participate in a clinical trial for a medication are more likely to prescribe that medication as opposed to the physicians who don’t. It’s a win-win situation for everyone as long as the pharmaceutical industry is able to capitalize on the opportunity.
