1. Its not all difficult to do that.
Primary thing that need to be done is the watching the naive site from the closest.
Get all the details of the site, then see what all things are missing and/or that can be modified for the use in clinical trial. We can install the things with the requirements.
SOP should be developed for that site that should be customized for the individual study.
Training can be done in session for the staff and doctors. Training them with PPT presentation can be a great help to them, afterwards, practical training can be given.
2. There are merits as well as demerits of working with such site.
Since site has no established practices to conduct the trial, site can be trained on CROs or sponsor's SOPs very easily and also site wont be hesitant to accept such procedures since they will not have established practices of there own. Several times when site has there established practices, they hesitate to accept new or different procedure which may be sponsor and / or project specific.
Real challenge will be training. The training should be consummate. The concept of clinical trial and GCP should be made very clear to personnel of site. Also through out the trial constant communication of monitor with coordinator and investigator will make huge difference as such sites will require more than usual monitoring.
I think if training is given effectively and consummately and communication kept continuously then new site can be managed and trained very effectively.
3. It is not at all difficult to setup a site which is not involved in clinical research previously. But it is very much interesting to do that. It is necessary to start a clinical research in new site as well in new area so can get more patients in short time. To start a clinical research at new site, the key factor involved is the interest of PI as per my viewpoint.
If once PI is interested then all the training and things related to CR can be developed very easily. To make site staff aware regarding GCP and other regulatory involved in CR can be done by the different type of training. Conduct of the weekly seminar related to different topic of CR at new site will be more helpful as per my view. Site SOP also help a lot to develop a new site as training can be provide as per site SOP very easily.
The experience CRC should be place at new site so all the things can be handle and trained by CRC very smoothly over there. It will reduce the frequent monitoring from the sponsor/CRO. For the same, SMO may help to burden off the investigator, sponsor/CRO to set up a new site which was never be involved in CR.
4. There are two Considerations for these questions.
Consideration 1:
• If you want to develop & train a new site it is very difficult to keep watch on each individual activity on site,as site is not comprise of only PI or Sub-I.
• Requires more energy, efforts, your valuable time & funding.
• Are they really following GCP & required guidelines in the trial related activities, as they are not aware of ICH-GCP & other regulatory required guidelines.
• You may not know the people surround you, are they really eligible?
• Not only GCP & regulatory required training is essential, but there are lot many things to be taken care of.
• Does the site have there own interest for conducting trials.
•Research staff is comprise of many individuals, Research Sub-I/Co-I, Trial coordinator, Nursing staff, Pharmacist
• Lab head, Phlebotomist, & PI. All must be motivated.
• Are they able to perform trials in the most efficient manner? As you imagined.
• A new site doesn’t know about the recruitment strategies.
Consideration 2:
There is no requirement as such of forming a new site, as there are good sites available for conducting clinical trials,Little training will suffice your need.
• Consuming less energy, efforts &; valuable time.
• Need to Work on lesser extent as they are previously trained site or established sites & give you good output.
• Already established hence not required much funding
• Hence it is always better to have those sites that have all these facilities already & committed to do work as upon your SOPs.
Disadvantage:
• There is still no guarantee of conducting trials in good manner, as you wish, but this is less obvious.
• There might be competitive trials present on site, hence recruitment may hamper.
Hence ,only training & providing few facilities won’t work out for forming a good, productive &; responsible site.
