In a previous article we considered some of the advantages of working with clinical trial research organizations or contract research organizations (CROs). There are also some possible disadvantages that should be weighed with the advantages when making a decision about whether to use one. Here are 4 such points to consider.
1. Conducting trials offshore may raise ethical issues
There has been criticism of offshore clinical trials in that some have claimed some companies have taken advantage of populations in distress in order to conduct clinical trials which they would not have conducted elsewhere. Perhaps the trial that attracted the most criticism was the 1996 Trovafloxacin Trial held in Kano, Nigeria. This trial was conducted during a meningitis epidemic. US pharmaceutical company Pfizer conducted a clinical trial to test its antibiotic drug, trovafloxacin aka Trovan. 200 children we involved in this trial. 100 were given trovafloxacin, and the other 100 were given a standard treatment called ceftriaxone. Local authorities from where this trial was conducted report that more than 50 children died in this experiment, while many others developed mental and physical deformities. A lawsuit ensued in which Pfizer denied the deaths resulted from the clinical trial although Pfizer eventually agreed to settlements with some of the families of those who died.
When deciding whether or not to use a CRO to conduct a trial offshore whether or not doing so could attract criticism or be seen as taking advantage should be kept in mind. Also you may want to take measures to make sure that all trials conducted offshore still comply with the ethical requirements of your own country e.g. making sure appropriate consent is obtained from participants. It may be advisable to draft appropriate terms to ensure this occurs in your contracts and agreements with the CRO with whom you engage.*2. Drugs may react differently to those of different ethnic backgrounds
It is unclear whether the result of the Pfizer trial would have been different had it been conducted on a population of a different ethnicity. It is possible that certain drugs will respond differently to persons of different ethnic backgrounds. This is something which needs to be kept in mind when deciding whether to conduct a clinical trial offshore using a CRO. It may be wise to make sure the clinical trial is conducted on a population of similar ethnicity of the one to which the company intends to primarily market and sell the end product.
3. Possible confidentiality loss
When engaging a CRO your company will be sharing confidential information (including intellectual property information). It is important that you engage a CRO which your organization is confident will maintain your company’s confidence (you should also have a watertight written agreement to this effect with them). You should also keep in mind that if you are engaging the services of a CRO that is based in another country, or that will conduct part of the trial in another country, that the laws relating to intellectual property may be different in that other jurisdiction. Make sure you allow for this in all written agreements relating to your engagement of them.
4. Project control loss - possible loss of control over quality
When engaging a CRO to assist in conducting a clinical trial keep in mind you will lose control over some of the trial process. You should make sure that you engage a CRO that has similar professional standards to that of your own. You may also want to specify in your agreement what these standards are and how any aspect of the trial process with which you are specifically concerned should be carried out.
Keep in mind when doing this that if you are conducting the trial offshore there may be different regulations and standards that apply to conducting clinical trials to those which apply in your own country. The medical professionals who are carrying out the trial may also have different training than those of the same profession within your home country. You may also want to make sure you are aware of all the professionals involved in the clinical trial process, the training they have received and accreditations they hold and maintain the right to veto any professionals from being involved with whom you do not feel meet the appropriate standards of qualifications.
So there you have some possible disadvantages of engaging a CRO for a clinical trial. What are your thoughts? Have you engaged a CRO for a clinical trial? What do you believe are the pros and cons of doing so?
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*For an example of a trial where informed consent was not obtained have a read of this article .
This article was written with the assistance of Jennifer Tran who interned with ContractRoom over the summer.