There are so many documents, contracts and people involved in clinical trials. These include:
a) Non-disclosure agreements;
b) Clinical Trial Agreements that need to be agreed to by all corporations and entities involved;
c) Protocol and policy documents; and
d) Letters of indemnity and consent forms for test patients.
Some tips for ensuring all documents are appropriately drafted and trials are carried out efficiently and effectively include the following.
1. Make sure those who are responsible for carrying out the day-to-day work under the trial are involved in the drafting process for documents and contracts. The document which appears to involve the most amount of negotiating and back-and-forth is the Clinical Trial Agreement itself. If parties involved in the day to day carrying out of the trial are not consulted in drafting this agreement some clauses may be included by legal professionals as a matter of course that are inappropriate.
For example, Lucy Robins, JD, attorney at law and legal consultant to the University of Maryland Medical System in Baltimore, MD, explained to AHC Media that a standard clause in clinical trial agreements is one that generically explains the disposal process for unused drugs. She found out when speaking to those involved in a particular trial that the disposal of unused drugs would be very costly and time consuming as well as subject to environmental regulatory requirements. It was important in this case that all parties involved in carrying out the trial discussed and came to an agreement about how unused materials would be disposed of and who would bear the costs before the clause relating to this was drafted and added to the agreement.*
Other clauses which may cause issues, if not properly discussed, include those relating to the intellectual property - e.g., when can the results of the study be published, which parties own the IP discovered during the trial and clauses relating to budget and payment terms.*
2. Establish a process for monitoring contracts. This not only includes ensuring that all contracts, disclosures, consent and other agreements are properly executed before the commencement of the trial but also that they are properly complied with during the trial’s duration.
This may mean choosing one person or a establishing a team who will have the responsibility for ensuring all contracts are properly signed and submitted, keeping all the contracts in a place where they can easily be retrieved and ensuring all contractual obligations are kept on track by obtaining regular status updates from relevant parties and communicating these to all those affected.
Once the trial is completed, this person or team will also have the responsibility for ensuring all tasks, such as disposal of unused drugs, are carried out in accordance with the contract. They will also be responsible for reviewing whether the contracts were adequate or whether any clauses may need to be redrafted or discarded for future trials.
3. Ensure all international issues including interjurisdictional and cultural issues are identified and appropriately addressed.
Many clinical trials that are run today involve international and interjurisdictional elements. Contracts and other agreements or policies may need to be adjusted for different jurisdictions to allow for different laws and regulatory systems. However, it’s important also to keep agreements as similar as possible across jurisdictions to minimize confusion and maintain efficiencies. In order to ensure all documents are drafted appropriately, some pharmaceutical companies employ an international law firm with offices in all the countries to which the clinical trial agreement relates. Others employ one attorney who is familiar with the laws in all jurisdictions to oversee the legal processes but employ different attorneys in each jurisdiction.
Cultural differences also need also be considered in the practical application of the clinical trial. For example, the questions posed to participants to elicit whether drugs are causing certain symptoms may need to be adapted. For example in one study a question “Do you prefer to stay at home, rather than going out and doing new things?”, was meant to determine whether a particular medication made participants depressed. However, this question was posed to people living in Malaysia where there is a great emphasis on family living. This question elicited a higher positive response from participants living there than from other cultures without the same emphasis due to the cultural difference rather than any effect the drug being tested was having upon them.**
Another example of a cultural difference that needs to be understood is that in relation to pain. Several studies have shown that perceptions of how pain should be addressed have had an effect on reporting its presence in clinical trials. In Asian cultures pain is seen as something that should be accepted as a part of your illness. As a result, in cancer studies involving Asian American patients those of Asian ethnicity underreport their experience of pain.**
To ensure all cultural issues are appropriately addressed, it may be advisable to retain someone who is specialised in addressing cultural issues in this context such as an anthropologist with experience in the cultures with whom you are working and one who is also familiar with the clinical trial process.
4. It may be worthwhile engaging a clinical research organization to help with the entire clinical trial process. Some of the things such organizations can assist with include planning the strategy of a trial, all the logistics of the execution of it as well as patient engagement. In a forthcoming article we will provide you with some tips for deciding whether or not to engage such an organization and how to choose the clinical research organization with which to engage.
So there you have 4 tips for keeping your clinical trial documentation on track. What are your thoughts? Have you been involved in a clinical trial? What worked and what didn’t? What would you advise those planning future clinical trials?
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*Efficient Contracting Processes for Clinical Trials...From The Legal Perspective by Sara Grimball - http://ow.ly/bKYe300gdAi
** Language and Culture in Clinical Trials by Faiz Kermani, Phd and Karen Politis Virk - http://ow.ly/jcES300gdiV