Often the first partner to be consulted when setting up a clinical trial is the principal investigator. Taking up a special role throughout the course of a study, they are responsible for overseeing the conduct and quality of the trial at the clinical site centre, to stay within regulatory and sponsor requirements, as well as to ensure good clinical practice (GCP) and perhaps most importantly patient safety.
An often underestimated process, the right or wrong choice for an investigator can influence and modify the course of a trial dramatically.
The sponsor company, the outsourced contract research organisation (CRO), study coordinators and clinical site staff, all have to work for the same purpose to deliver a successful trial untouched by any potential flaws in clinical practice.
This often lies in the hands of the principal investigator, who as the leader in the study centre is the first point of contact for all study partners.
The imperative role of investigators will also be discussed at Arena International’s Outsourcing in Clinical Trials West Coast congress, taking place on 15-16 February 2012 in Burlingame in California, US.
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Ahead of the event, we talk to APT Pharmaceuticals’ vice-president of clinical affairs Wendy Verret about the delicate process of investigator selection, and unveil some of the tips, tricks and best practices for a successful clinical outcome from a sponsor’s point of view.
Elisabeth Fischer: How do you identify potential investigators for a clinical trial?
Wendy Verret: I would say that for us at ATP it might be a little bit different then at other companies with larger trials. We conduct lung transplant trials which, in the grand scheme of things, are quite small.
Companies that concentrate on a smaller therapeutic area generally know all of the available investigators in the area, and if they don’t know them in person they at least know about the professionals available in the field.
If I was to work in a larger therapeutic area then we would rely very heavily on CROs who have the necessary expertise in certain therapeutic areas. such as for instance oncology or neurology to help identify a large group of investigators. We would use the same CROs in the same field of study.
For a larger therapeutic study you do have special relationships with certain investigators that you will maintain throughout the course of the clinical programme. That’s the combination.
Investigators are involved from the very start of a clinical trial. Generally, they are the first contact, even before we try to get a study coordinator contact for general administrative issues. Generally the first contact is the investigator and project leader when we send out the feasibility questionnaires. Investigator relations are therefore quite important from the very first beginning.
EF: Should site selection and investigator selection go hand in hand?
WV: Site and investigator selection should definitely go hand in hand. You can have a great investigator but, with no study staff, who can get your study done?
It’s key for the investigator to be well-staffed because they are generally very busy and they don’t get the study done – their staff do.
Obviously they are the study leaders and therefore should be heavily involved but they’re not going to do the day-to-day work for the most part – at least not in the US.
Therefore, the selection and evaluation of an investigator and clinical site definitely belong together and are critical for the successful completion of a trial within budget and timelines.
EF: Who is responsible for the training of investigators for a trial?
WV: I think it is a mistake to rely on a CRO to do 100% of the training of your investigators and study sites.
For a clinical trial to start off right and be successful, the sponsor company needs to be heavily involved throughout the course of the study but particularly in the trainings. I would suggest that the sponsor conducts the majority or a large portion of the investigator training.
The first step is the investigator meeting, typically held before the beginning of a clinical trial. The purpose of this meeting is for the site staff and the sponsor study team to meet and discuss the trial in general.
I think this is the one of the best opportunities for the research teams to learn what the clinical trial will be like, to discuss potential issues and share strategies and best practices from previous studies.
The CRO is left with training on CRO-specific items such as the electronic data capture system. But in terms of the therapeutic area, the protocol and any specific study-related procedures that are important for the primary endpoint – that should all be done by the sponsor company.
It also shows the sponsor company is committed, that they want the trial to become a success and really want to cooperate with the investigator. I believe it starts the study off right.
EF: How can companies tighten investigator and site relationships in order to get the best possible patient and trial outcome?
WV: As I said, I think it’s crucial for the sponsor to be involved in all the aspects of the trial. It would be wrong for a sponsor to chose the CRO and then say "Ok you guys run it".
I find that generally leads to a faulty trial ending. In my experience, maintaining close relationships with the investigator and study site staff throughout the trial is the best bet.
We at the sponsor company are in touch with the site everyday. Obviously, we try not to overlap our communication with the CRO and make sure we have a very open communication plan and that everyone can understand this plan, including the site, so there’s no confusion. That’s the most important thing: to maintain contact with your site and maintain a close relationship.
The other thing we find is really helpful is to have periodical meetings. This entails not only investigator meetings, let’s say at a conference where you have a brief lunch, but also to have yearly study coordinator meetings to make sure they understand that we appreciate them. We have to make sure they know that we want to listen to their thoughts of how we could improve a study, as well as also keep them well-trained on the study by giving updates.
Often if you have those meetings at big conferences the study coordinators don’t go, so they feel a little left out. Therefore it’s important to have them as the primary audience for the yearly meetings, which they highly appreciate and it seems to help recruitment for the clinical trial a lot.
If I had to put an umbrella over that whole process of organising a clinical trial I would say communication is central.
EF: How dependant is the success of a clinical trial on the right selection and training of an investigator?
Without a good clinical investigator you are not going to have a good clinical trial. But that said, I think the strength of their study team can often make up for any potential weaknesses of an investigator.
If you have an investigator is not 100% on top of everything, you can still have a successful trial. It’s a partnership between an investigator and their study team.
You can’t have a successful study without a good investigator but you can’t have a successful study without a good study team. An investigator alone is not going to lead to success.
In general, I would like to say that I think sponsors fall into traps of relying too much on their CROs. CROs are great but they can’t do everything.
Even though you are paying a lot of money for their service it doesn’t mean you can just sit back and let the trial go on auto-pilot. The sponsors have to work just as urgently as the CROs on a day-to-day basis to keep the trial moving forward.
Arena International’s Outsourcing in Clinical Trials West Coast takes place on the 15 and 16 February 2012 in Burlingame, California, US.
