1) Narrow down prospective countries and selecting the right sites
In prepping for a clinical trial, sponsors need to decide where the study will take place. There are a number of factors that could influence where you carry out the trial, such as the patient population. In this case, the strategy you adopt may necessitate your study be performed in a specific country, so it's vital sponsors bear this mind before moving forward. Once you've determined where you will conduct your trial, ensure the sites you select are equipped to meet the needs of your study, and make sure the site staff has the necessary competencies.
2) Choosing in-house collaborators; determining essential characteristics of your staff
When it comes to putting together the clinical team, the end goal should always be in mind, so plan long-term. As clinical trials are complex and arduous in nature, the team you put together need to be in it for the long haul. Be sure to create a team that's enthusiastic and curious, willing to work hard. Furthermore, select a CRO whose team composition matches your own. While not everyone involved in the trial needs specialist knowledge of the therapeutic area, the team leader must have a solid grounding in the drug and its pathology.
3) Prepare your budget, consider the regulatory requirements
When it comes to budgeting a clinical trial, it's not uncommon for sponsors to wait for the CRO to submit a budget before determining how much the study may cost. However, experts say this is the wrong course of action. When developing your budget, sponsors must be proactive and have a fair idea of how much everything will cost. What's more, the sponsor must do due diligence when filling out the case report form to ensure the drug or device is approved by the relevant legal authority. They should also understand the regulatory environment of the therapeutic area while having a good relationship with the agencies.
4) Developing a Protocol
It's important that sponsors develop a protocol that has had input from key stakeholders. Additionally, as the standard of care can vary from country to country, the protocol must factor this into the equation.
5) CRO selection
It goes without saying that selecting the right vendor is one of the most important stages in the drug development process. More often than not, CRO selection is rushed to the detriment of the trial. Therefore, sponsors should thoroughly vet prospective vendors by initially gauging whether they are the right fit. Establish common ground with each company while clarifying what would be expected of them if chosen as the sponsor's preferred partner. Don't select a CRO based on the budgets they may put forward, assess everything from their personalities to the competencies of individuals, as well as the methods proposed by the companies. Although it can take time and personal involvement, the study will ultimately benefit.
6) Real-time auditing
Once a preferred provider has been selected, work on the trial begins at full speed. After the first patient is enrolled, the clinical trial manager should carry out an early audit to validate the competency of not only the monitor, but site staff all while ensuring the protocol is being carried out effectively. Ensure the process this is repeated at the various sites in participating countries for consistency. Carrying out an audit at the start of your subject enrolment (and in the middle) is important as it allows you to identify, where possible, issues (protocol deviations, staff inadequacy, etc.) that can be addressed. By identifying and tacking potential problems early on, you can improve the overall quality of your data.
*For more information on the core tenets of starting a clinical trial, read Pierre Corin's Reflections on how to successfully start a Clinical Trial here