Clinical research is a fundamental health care tool that brings life-saving products and treatments to the market each year. It is a fundamental component of the health care wellbeing of society as a whole.
All new medications undergo rigorous trials that seek to demonstrate the safety of the new drug as well as its effectiveness at treating the underlying indication. These trials are conducted in many settings such as hospitals and academic institutions. In the United States, many of these trials are successfully conducted in independently owned clinical research sites. These sites are the backbone of a successful trial, since they involve experienced Private Investigators (PIs) that are passionate about a specific indication and are intimately involved with their patients and their community.
Managing a successful clinical research site requires hard work, dedication and a passion for excellence. A successful clinical research site is not only a critical component of the development of life saving medications, but it can also be a profitable business if managed well. Below are the five most important characteristics in ensuring that your clinical research site is successful.
- Highly experienced PIs:
The backbone of all clinical trials is the Principal Investigator. A successful site must have highly experienced PIs that are specialized in the indication being studied and has a strong relationship with his/her patients.
The PI will be a determining factor in establishing the most important component of clinical trials: trust. A good PI will advise and counsel their trial participants about the merits and potential of the drug being studied as well as the risks involved. Without a good PI it will be impossible to have a successful site.
- Having a great Clinical Research Coordinator:
If the PI is the key to a successful trial then the CRC is the gatekeeper. Everything in the study will go through the CRC, they are the essential piece of the puzzle.
A good research site will have an experienced CRC that is well versed in the industry and has participated in numerous trials. They must have a proactive approach and have incredible attention to detail. Clinical trials must be run with impeccable organization so it’s imperative that the CRC is a good manager and organizer.
- A large and diverse patient database:
Meeting trial enrollment targets is fundamental for a site to achieve a good reputation with Sponsors and CROs. The only way to ensure that your site consistently meets the targets and is considered for future studies is to have a large patient database.
The FDA has issued recommendations in the past year that seek to greatly increase the diversity of participants in clinical trials. The industry is expecting a government mandate to make diversity a requirement in future clinical trials. For this reason, it is imperative that successful sites have a diverse patient population and database. Diversity not only refers to race and ethnicity but to other characteristics such as age, gender, sexual orientation and rural location. If your site is located in an area that is not very diverse from a racial/ethnicity standpoint you can still enroll diverse subjects based on capturing other populations that are considered diverse.
Many sites wonder how to increase their patient database and how to enroll more patients in their trials to meet their targets. The most important tool here is to establish a solid connection within the community where the site operates and undertake concrete actions such as visiting local health community centers and explaining the benefits of participating in clinical trials for their patients.
Other community engagement actions such as participating in community fairs and offering free blood pressure readings outside supermarkets and other community stores is very effective in letting patients know about clinical trials and about how you can help their health care needs. The most important thing is to establish trust in your community and realize that community involvement and outreach requires a long-term commitment to ensure your site becomes well known.
- Sound finances.
Running a successful site requires strong financial discipline and planning. Just like any business, keeping a good control of finances and cash flow discipline is critical. Running a site will require making upfront payments to many vendors.
The patient stipend is particularly an area where sites will need to have a solid revolving capital to be able to cover this expense while awaiting payment from Sponsors/CROs. There are studies where this takes longer than others and being unable to cover these expenses because of a lack of cash flow can lead to a successful site running into financial difficulties.
It is strongly recommended that sites maintain a prudent cash reserve for their operations and if the revolving capital is used then it should also be replenished when the site is paid by the Sponsor or CRO.
- A steady stream of studies.
This is of course obvious but it’s critical to ensure that a site is financially successful. How can your site get more studies? That is the question all sites ask themselves. The first step is to invest in business development. This includes a professional and attractive website, a strong presence in LinkedIn and other industry outlets where you can reach out to Sponsors and CROs and let them know about your site’s capabilities and experience.
Another very important component of participating in more studies is to work with established research networks. An established research network like MplusM Research Network can bring you a steady stream of studies based on your experience and capabilities. By working with a network, you also have more opportunities to increase your budgets overall since the network negotiates on your behalf with a large footprint of sites. In MplusM Research Network’s case, over 60 sites are part of the network, thus increasing your budgeting power through the economies of scale of the network.
Having a successful clinical research site is one of the most rewarding businesses out there. You are at the forefront of the pharmaceutical industry’s development of potentially life saving treatments. When a trial participant benefits from a breakthrough medication you are responsible in part for that. The keys to a successful site have been laid out above. With good management and building a long-lasting relationship of trust with your patients and in your community, your site will ensure long term financial success.