In this Industry Viewpoint, Clinical Trials Arena (CTA) sat down with Rita Nigam PhD, who is a Clinical Consultant.
Dr Nigam assists companies in managing clinical trials. Part of her role is to forecast budgets and timelines for prospective trials. She is also involved in designing clinical trials and implementing protocols all while ensuring studies are run in a cost-efficient and timely manner.
In this interview, Dr. Nigam speaks to CTA editor, Henry Kerali, about some of the challenges she faces working with a small company as the organization moves from Phase I to Phase II.
Clinical Trials Arena: Working in a small company, what would you say are some of the biggest issues you face?
Rita Nigam: Working with a small clinical team and supervising the clinical operations team, while overseeing two-three sponsor trials simultaneously can be challenging. What’s more, these trials are all primarily in oncology. Oncology trials are very complex and can require at least one manager per trial. It is a very competitive field and very difficult to recruit patients. Most trials are conducted at multiple sites to meet study targets and therefore require a lot of management with a relatively small team.
Currently, combination immunotherapy trials are being conducted. As a result, you have to work with partners that may have different ways of governing their trials and therefore you need to accommodate your partners. It is challenging for a small team to ensure there is proper oversight of the trial and at the same time manage partners. Moving forward from Phase I to Phase II, combination trials will become very complex.
CTA: To what extent is resourcing an issue and how does the company manage trials with limited staff?
RN: Small companies should depend on clinical research organizations (CROs) and other vendors. Departments that are not being developed in-house should be outsourced to a vendor. Furthermore, the sponsor should ensure they have at least one qualified person designated to manage the CRO and other vendors.
As new people are hired, especially for more senior positions (Project Management, QA Director, HR, CMO), prior to developing new systems and processes, it is important any new employee talks to the appropriate people in the company to see what is in place, and what is working to avoid duplicating pre-existing processes.
Part of the growing pain is the time it takes to get new employees knowledgeable about all aspects of the company, while at the same time keeping existing employees motivated. Therefore, internal promotions should occur within organizations. However, companies should provide appropriate training to existing employees prior to promotions to ensure a smooth transition.
CTA: In your experience, what have you found to be the best practices of working with limited resources?
RN: Over the course of my career, I have seen companies fully outsource their trials and the sponsor does not identify someone internally to manage the CRO. Firstly, it is essential sponsors choose a sponsor representative with appropriate experience to provide CRO oversight to ensure the company achieves their goals.
Secondly, try and cultivate a team with diverse backgrounds. In clinical trials, issues will always arise and as a company if you can draw on various insights from people who have experience in different areas that will enable you to resolve any developing problems in a timely manner.
Another reason why it is important to assign one manager per trial is to provide excellent customer service. It is important to have a 24 to 48-hour response turnaround to any questions or issues that arise at clinical sites. That will allow you to maintain the clinical site’s interest in your trial and study timelines.
CTA: Could you provide a real life example of dealing with an underperforming vendor?
RN: With one company, we decided to conduct certain aspects of a clinical trial in-house for a small Phase Ib oncology trial at two clinical sites. More specifically, the sponsor conducted clinical trial management and monitoring in-house, and outsourced data management to a small local group. The data management group had limited experience in oncology and resources. As a result, study timelines were extended to resolve all data queries at the clinical sites prior to database lock.
The sponsor also realized that it was a lot of work maintaining the trial master file (TMF), monitoring and developing standard operating procedures (SOPs) to conduct clinical trials in-house with limited staff. At the time, the company had budgetary constraints, but no matter how small or the phase of the trial, you require all types of skill sets in the various departments (medical, regulatory, clinical trial management, project management, data management, etc.) to successfully conduct a clinical trial. So it’s best for small companies to outsource to full-service CROs. In the long run you will save time and money.
CTA: Lastly, what advice would you give to another small company dealing with similar resourcing issues while conducting complex studies?
RN: It is critical to have the right people in place who are knowledgeable in managing clinical trials prior to hiring a CRO. You need to develop your clinical resourcing plan based on the clinical phase of your company. For example, when a company progresses from Phase I to Phase II, quality assurance (QA) is very important, especially for manufacturing and product development. Moving forward into Phase II, and potentially Phase III, regulatory becomes a priority. Based on the clinical phase of your company, you need to hire the appropriate resources well in advance of proceeding to the next phase.
*Rita Nigam, PhD is a Clinical Consultant. To follow-up with Rita with any questions or concerns, she can be reached at: [email protected]. Or feel free to post a comment below!