Essential Site Matters
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Do Site Matters Matter?
Yes! There are three parties involved in developing new medicinal products—the regulatory authority, the trial sponsor, and the clinical investigative site. There is also a fourth and essential party involved in the drug development process—the trial investigator, normally a doctor who will lead the clinical development program. Some doctors are keen to participate, while others are not. Because in reality, a majority of clinicians do not need to be involved in sponsored trials. The primary responsibility of a doctor, after all, is taking care of patients in everyday medical practice. In fact, only a few doctors will ever participate in an industry-sponsored clinical trial.
Doctors who embark on sponsored trials will many times be reluctant to be involved in a second sponsored trial. Around 40-50% will only participate in one trial. The reasons for this will be discussed below.
In this section — Site Matters — of the CTM website, we will address issues that are important for a physician to consider when taking part in a sponsored clinical trial. It is widely recognized that with good administrative support, many doctors would be keen to conduct sponsored trials. However, very few doctors have any experience in conducting clinical trials or have any access to administrative support. For doctors without clinical research experience, they will find that conducting a sponsored trial differs vastly from taking care of patients in the clinic.
Before a physician decides whether to participate in trial, there are a number of issues to consider. As mentioned above, around 40%-50% of investigators will never be involved in a second sponsored trial. The reason for this is the doctors have not understood the responsibilities of an investigator and the sponsor has adopted a poor investigator selection practice.
More Site Matters
The life sciences industry has a large network, many dedicated conferences and supporting media groups that all are focused on the industry's needs.
However, there is few similar activities that support the needs and interests of clinical investigators. Let us jointly make this website a resourceful platform for investigative sites.
Content and Format
We have listed seven different site matter issues that will be addressed separately:
Incentives Incentives to participate in sponsored trials: The incentives are different for each doctor and are dependent on age, interest, therapeutic area, hospital/clinic setting, etc.
Site Evaluation Site Evaluation: A clinical investigator should make an evaluation of his/her site to understand how well prepared the site is to embark on a sponsored trial. The evaluation also serves as an instrument to improve the site's administration and performance, but also as preparation for marketing the site to the industry.
Trial Evaluation Trial Evaluation: It is a large commitment for a clinical investigator to embark on an industry-sponsored clinical trial. The investigator must critically review the final trial protocol and the Investigator’s Brochure to understand if a certain trial is suitable or not.
Subject Recruitment Subject Recruitment: Subject recruitment is the single most important issue in clinical trials. A majority of sites are not able to meet the pre-defined number of subjects, totaling to approximately 80%.
Trial Agreement Agreement: Each trial or study is bound by a trial agreement that addresses a number of issues that are difficult to grasp for a layperson. It is not of interest for the industry to make changes to the agreement. It is therefore worthwhile for the investigator to consult an experienced legal advisor.
Trial Budget Budget: There are different ways to estimate a trial budget. The sponsor must pay for all trial-induced activities, because conducting a sponsored clinical trial is a 'fee-for-service' activity. Setting the budget too low will eventually lead to underperformance of the site. It is therefore important for both parties to discuss all the activities, procedures and responsibilities described in the protocol and to negotiate accordingly. There are additional items not mentioned in the protocol, e.g. study site set-up activities, investigator meetings, monitoring visits, etc.
Site Marketing Marketing of the study site: Study sites that are fully or partially dedicated research sites must actively promote and market themselves. The sponsor selects sites more or less by random and not necessarily based on past track records, experience and patient population available. An active marketing strategy is the only way to be successful.
Format: The seven site matter issues mentioned above can be explored in more detail from the pull-down list 'Site Matters'. Each topic includes some basic information and polling about the specific issues. There are Member Forums for each of the five topics, which can be found under the webpage Forum.